BioLogiQ, recently announced that test results show its NuPlastiQ MB BioPolymer, produced by blending NuPlastiQ GP with PBAT (polybutylene adipate terephthalate), is marine biodegradable. Performed by Eden Research Laboratory, results show 97% biodegradation of a GP/PBAT film in ocean water within a one-year period, according to ASTM-D6691 standards for marine biodegradability.
The key to this innovative new plastic compound is BioLogiQ’s NuPlastiQ GP General Purpose BioPolymer. GP is a 100% natural, renewably-resourced, plant-based resin (derived from the excess starch produced–and usually discarded–during potato processing) that has been certified by TUV Austria to marine biodegrade in 28 days. When PBAT is mixed with NuPlastiQ GP, it will also biodegrade in marine environments.
“Our ability to produce a marine biodegradable film using a material that was previously not marine biodegradable is a huge technical accomplishment that can significantly reduce both plastic marine debris and the negative effects this debris can have in our oceans. Given the current concern regarding plastics and ocean pollution, we are working on NuPlastiQ MB marine biodegradable formulations of NuPlastiQ GP with polyethylene and polypropylene. Our target applications are drink cups, straws, lids, and grocery sacks,” said BioLogiO’s president and founder Brad LaPray. He also noted that because the ability for plastics to biodegrade in a marine environment is so new and unusual, acceptable certification standards do not exist and that the company plans to work with industry and governments to develop new standards.
HAL Allergy announced the registration of SUBLIVAC® Birch 40.000 AUN/ml and SUBLIVAC® Trees 40.000 AUN/ml in Germany. These are the first marketing authorisations granted by the Paul Ehrlich Institute following the German Therapieallergene‑Verordnung (TAV).
The TAV was initiated by the German Federal Ministry of Health on 14November, 2008, and regulates the marketing authorisation requirements for frequent therapeutic allergens, in order to guarantee quality, effectiveness and safety.
“We are proud to be the first company that registers two products in line with the German Therapieallergene‑Verordnung”, says Harry Flore, CEO of HAL Allergy Group. “We acknowledge that the regulations set by the German authorities, are important for allergic patients in Germany, the largest European allergy market. Therefore, we were determined to register our sublingual birch and trees products. The studies to obtain these marketing authorisations are part of our extensive clinical development program and follow the new EMA requirements.”
The studies confirm that SUBLIVAC® Birch 40.000 AUN/ml shows significant and clinically relevant improvement for adults in all primary and secondary endpoints versus placebo.
Principal investigator Prof. Dr. Oliver Pfaar, Scientific Head at the Allergy Center Wiesbaden and Professor at the Medical Faculty Mannheim, University Heidelberg, Germany, also member of the Scientific Advisory Board of HAL Allergy Group explains: “In the phase II study we identified the optimal dose of allergen. Phase III demonstrated a strong clinical efficacy of 32% in the combined symptom and medication score, compared to placebo. There was a significant improvement in quality of life scores as well as important changes in immunoglobulins.”
https://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svg00hollandbiohttps://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svghollandbio2018-08-14 16:32:382018-08-21 16:35:10HAL Allergy first company to achieve marketing authorisations in line with Therapieallergene Verordnung (TAV)← #nieuws
Abbott opent woensdag officieel een nieuwe fabriek op haar productielocatie in Weesp. Met de opening van het nieuwe gebouw breidt de farmaceut de productie uit van dydrogesteron, een geneesmiddel dat wordt gebruikt om een progesteron-insufficiëntie bij vrouwen te behandelen.
De nieuwe fabriek vertegenwoordigt een totale investeringswaarde van 80 miljoen Amerikaanse dollar en bevat dezelfde moderne technologie als het reeds bestaande gebouw. Door deze investering verwacht Abbott haar totale productiecapaciteit met 60 procent te verhogen. Door deze investering blijft Abbott de grootste fabrikant van dydrogesteron in de wereld.
“We zien een toenemende vraag naar dydrogesteron in snelgroeiende landen zoals China, India en Rusland”, zegt Sieneke Bult, site director van Abbott’s fabriek in Weesp. “Een van de geneesmiddelen die we hier in Weesp met dydrogesteron produceren is levensreddend. Het heeft al een blijvende impact gehad op het leven van miljoenen vrouwen wereldwijd doordat het hen helpt zwanger te raken en te blijven.”
Groeiende vraag naar medicijnen
Vanwege een “groeiende vraag naar medicijnen van hoge kwaliteit” blijft Abbott continue investeren in het vergroten van haar productiecapaciteit in Weesp. Naast dydrogesteron produceert het bedrijf in deze plaats nog twee andere producten: Duphalac (lactulose) en Influvac (griepvaccin). In 2015 heeft Abbott een nieuwe influenza-fabriek gebouwd, die de productiecapaciteit vergrootte van 34 miljoen doses naar 54 miljoen doses.
https://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svg00hollandbiohttps://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svghollandbio2018-08-14 13:49:352018-08-14 13:49:35Abbott opent nieuwe fabriek in Weesp← #nieuws
Hoe de Europese regels rond genbewerking een poging om de banaan te redden torpederen.
Het valt niet op wanneer je in de supermarkt langs de goed gevulde schappen loopt, maar het gaat niet goed met de banaan. Ziektes tasten wereldwijd plantages aan. Eet je een banaan, dan is dat doorgaans een Cavendish. Het gros van de wereldhandel in gestoeld op die ene variëteit. ‘Het is een monocultuur van quasi genetisch identieke planten die jaarlijks vijftig miljoen ton bananen voortbrengt’, zegt Roel Sterken. Sterken is een biotech-ondernemer. In samenwerking met wetenschappers van de KU Leuven en het Vlaams Instituut voor Biotechnologie (VIB) werkte hij aan een start-up die met CRISPR-Cas9 bananen wou veredelen om ze beter bestand te maken tegen ziekte.
‘Tot ‘zwarte woensdag’’, zegt Sterken. Op woensdag 25 juli besliste het Europese Hof voor Justitie immers dat planten die het resultaat zijn van genbewerkingstechnieken zoals CRISPR-Cas9 onder de ggo-wetgeving vallen en dus dezelfde strenge en dure markttoelatingsprocedure moeten doorlopen als genetisch gemodificeerde gewassen. ‘Sindsdien is ons initiatief een doodgeboren kind’, aldus Sterken. ‘Dat is niet alleen jammer voor ons, maar ook voor miljoenen lokale boeren in meer dan 120 landen die afhankelijk zijn van de banaan.’
Vijftig keer sproeien
De wereldwijde monocultuur maakt de banaan kwetsbaar. Twee ziektes bedreigen de bananenhandel. ‘De Panamaziekte is een schimmelziekte van de wortels die de planten doet afsterven’, zegt Sterken. ‘Daar is niets tegen te beginnen. Een aangetaste plantage wordt in quarantaine geplaatst en is verloren voor toekomstige bananenteelt. In de Filipijnen, één van de grootste bananenproducenten ter wereld, is in sommige gebieden meer dan de helft van de plantages verloren gegaan.’
‘De tweede ziekte, Black Sigatoka, is een bladschimmel. Die is wel onder controle te houden, maar enkel door intensief gebruik van fungiciden. De gemiddelde plantage wordt 50 maal per jaar besproeid.’
Sterken ziet in CRISPR-Cas9 een mogelijke oplossing. ‘Er bestaan bananenvariëteiten die resistent zijn tegen Black Sigatoka of de Panamaziekte. Ze zijn echter niet commercieel interessant: ze brengen te weinig op, rijpen te snel of smaken niet lekker. De resistentie overbrengen naar de Cavendish via klassieke veredeling kan niet, want de bananenplanten zijn steriel en worden door stekken vermeerderd. Wil je opnieuw vertrekken van de oerbanaan om tot een commercieel interessante banaan mét resistentie te komen, dan ben je minstens vijftig jaar zoet. Wat we wel kunnen doen is kijken welke genetische verschillen aan de basis liggen van de resistentie. Met CRISPR zou je de genetische code van de Cavendish vervolgens zo kunnen aanpassen dat ze identiek is aan die van de resistente variëteit.’
De hele wereld volplanten met dezelfde banaan, is dat niet om problemen vragen? ‘Die situatie is het gevolg van het feit dat geen enkele andere variëteit even geschikt is voor export als de Cavendish en veredeling zo moeilijk is’, zegt Rony Swennen, bananenexpert aan de KU Leuven en ook bij het initiatief betrokken. ‘Was dat niet zo, dan zouden er net zoals bij appels verschillende variëteiten op de markt kunnen komen. Ook daar zou CRISPR bij kunnen helpen.’
The Food and Drug Administration approved Alnylam’s patisiran for the treatment of peripheral nerve disease (polyneuropathy), which is caused by hereditary transthyretin-mediated amyloidosis (hATTR). This is the first FDA-approved treatment for patients with polyneuropathy caused by hATTR, a rare, debilitating and often fatal genetic disease characterized by the buildup of abnormal amyloid protein in peripheral nerves, the heart and other organs. It is also the first FDA approval of a new class of drugs called small interfering ribonucleic acid (siRNA) treatment.
“This approval is part of a broader wave of advances that allow us to treat disease by actually targeting the root cause, enabling us to arrest or reverse a condition, rather than only being able to slow its progression or treat its symptoms. In this case, the effects of the disease cause a degeneration of the nerves, which can manifest in pain, weakness and loss of mobility,” said FDA Commissioner Scott Gottlieb, M.D. “New technologies like RNA inhibitors, that alter the genetic drivers of a disease, have the potential to transform medicine, so we can better confront and even cure debilitating illnesses. We’re committed to advancing scientific principles that enable the efficient development and review of safe, effective and groundbreaking treatments that have the potential to change patients’ lives.”
RNA acts as a messenger within the body’s cells, carrying instructions from DNA for controlling the synthesis of proteins. RNA interference is a process that occurs naturally within our cells to block how certain genes are expressed. Since its discovery in 1998, scientists have used RNA interference as a tool to investigate gene function and its involvement in health and disease. Researchers at the National Institutes of Health, for example, have used robotic technologies to introduce siRNAs into human cells to individually turn off nearly 22,000 genes.
This new class of drugs, called siRNAs, work by silencing a portion of RNA involved in causing the disease. More specifically, Onpattro encases the siRNA into a lipid nanoparticle to deliver the drug directly into the liver, in an infusion treatment, to alter or halt the production of disease-causing proteins.
Affecting about 50,000 people worldwide, hATTR is a rare condition. It is characterized by the buildup of abnormal deposits of protein fibers called amyloid in the body’s organs and tissues, interfering with their normal functioning. These protein deposits most frequently occur in the peripheral nervous system, which can result in a loss of sensation, pain, or immobility in the arms, legs, hands and feet. Amyloid deposits can also affect the functioning of the heart, kidneys, eyes and gastrointestinal tract. Treatment options have generally focused on symptom management.
Onpattro is designed to interfere with RNA production of an abnormal form of the protein transthyretin (TTR). By preventing the production of TTR, the drug can help reduce the accumulation of amyloid deposits in peripheral nerves, improving symptoms and helping patients better manage the condition.
“There has been a long-standing need for a treatment for hereditary transthyretin-mediated amyloidosis polyneuropathy. This unique targeted therapy offers these patients an innovative treatment for their symptoms that directly affects the underlying basis of this disease,” said Billy Dunn, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research.
The efficacy of Onpattro was shown in a clinical trial involving 225 patients, 148 of whom were randomly assigned to receive an Onpattro infusion once every three weeks for 18 months, and 77 of whom were randomly assigned to receive a placebo infusion at the same frequency. The patients who received Onpattro had better outcomes on measures of polyneuropathy including muscle strength, sensation (pain, temperature, numbness), reflexes and autonomic symptoms (blood pressure, heart rate, digestion) compared to those receiving the placebo infusions. Onpattro-treated patients also scored better on assessments of walking, nutritional status and the ability to perform activities of daily living.
The most common adverse reactions reported by patients treated with Onpattro are infusion-related reactions including flushing, back pain, nausea, abdominal pain, dyspnea (difficulty breathing) and headache. All patients who participated in the clinical trials received premedication with a corticosteroid, acetaminophen, and antihistamines (H1 and H2 blockers) to reduce the occurrence of infusion-related reactions. Patients may also experience vision problems including dry eyes, blurred vision and eye floaters (vitreous floaters). Onpattro leads to a decrease in serum vitamin A levels, so patients should take a daily Vitamin A supplement at the recommended daily allowance.
The FDA granted this application Fast Track, Priority Review and Breakthrough Therapy designations. Onpattro also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.
Approval of Onpattro was granted to Alnylam Pharmaceuticals, Inc.
EuropaBio is delighted to announce European Biotech Week 2018. Between 24 – 30th of September, the EU will, for the sixth time, witness a week packed full of biotech-focused activities and events. European Biotech Week will be held alongside simlar initiatives, planned across 4 continents as part of Global Biotech Week.
This year, we build on the success of European Biotech Week 2017, where a record-breaking number of 19 European countries held over 150 events and activities. This annual initiative, aimed at increasing dialogue around and understanding of biotech, comprises of a diverse set of activities that include open doors visits, symposiums, round table discussions, fun runs, flashmobs, competitions, roving labs, theatre plays, hands-on experiments and much more.
Commenting on the event, Chair of EuropaBio, Tjerk de Ruiter, said “Biotech has been benefitting people and planet for many years now, providing solutions to some of society’s most pressing challenges. It helps us to use our resources more efficiently, provides food and feed for a growing population and develops treatments for unmet medical needs. In biotech week, we take time out to celebrate these acheivements, together with a growing community of biotech enthusiasts of all ages and nationalities.’’
He concluded: ‘’One of the best things about the events that this week brings together is the creativity on show and the shared passion and enthusiasm for communicating on biotech. In the EU, we have a wealth of success stories to share which are being created by the young people studying biotech and by those innovating in this field. Ultimately, they are the ones who make Biotech week the success that it is’’
“We invite you to see what is going on near you on www.biotechweek.org and www.globalbiotechweek.ca, and we wholeheartedly thank all the biotech supporters who have contributed to this year’s amazing programme already. Lastly, it’s not too late to hold your own eventsto show why there is no science like biotech science!”
The company have together with the UK Cystic Fibrosis Gene Therapy Consortium (GTC), consisting of Imperial College London and the Universities of Oxford and Edinburgh, Imperial Innovations, and Oxford BioMedica (OXB) announced a global collaboration to develop a first-in-class, long-term therapy for patients with cystic fibrosis (CF).
The new partnership brings together the academic partners’ leading expertise in developing gene therapy for CF and OXB’s leading expertise in manufacturing lentiviral vector-based therapies with Boehringer Ingelheim’s capabilities in drug discovery and the clinical development of novel breakthrough therapeutic agents, reports the collaborators.
A possible universal treatment option
The collaboration will focus on a novel approach using a replication-deficient lentiviral vector in an inhaled formulation, to introduce a healthy copy of the CFTR gene into the cells of the lung. This method has demonstrated high gene transfer efficiency and offers the possibility of repeated administration to maintain the therapeutic effect. Gene therapy is the only therapeutic approach to date that can address all CFTR gene mutations, thus potentially offering a universal treatment option.
Three-way partnership
“This novel three-way partnership brings together an unparalleled combination of clinical, scientific, manufacturing and commercial skills in an effort to develop new treatments and make a major contribution to the lives of patients affected by cystic fibrosis,” stated John Dawson, Chief Executive Officer of Oxford BioMedica. “The GTC has been working determinedly for over 15 years to get to this exciting point of forming a partnership with Boehringer Ingelheim, a global pharmaceutical company with respiratory expertise. Our contribution to this partnership reaffirms our leading position in the development and manufacturing of lentiviral vector gene therapy products at large scale. We look forward to working with our new academic and industry partners.”
“Through this collaboration, we are joining forces with some of the top talents in this disease space to propel treatment advances forward,” said Clive R. Wood, Ph.D., Senior Corporate Vice President, Discovery Research at Boehringer Ingelheim. “Bringing together our existing expertise as a leader for nearly a century in the discovery and development of therapies that have advanced patient care in respiratory diseases with the gene therapy knowledge of our partners, we aim to unlock unprecedented opportunities for patients with this devastating disease, who are desperately waiting for better treatment options.”
Collaboration details
Boehringer Ingelheim has received an option to license the exclusive global rights to develop, manufacture, register, and commercialise this lentiviral vector-based gene therapy for the treatment of cystic fibrosis. Financial terms are not disclosed. During the option period the partners will work closely together to pursue the development of this innovative approach financed by Boehringer Ingelheim. The new collaboration is a joint initiative of Boehringer Ingelheim’s Respiratory Therapeutic Area and Research Beyond Borders (RBB), which is one of the pillars of Boehringer Ingelheim’s research and development strategy and explores emerging science, disease areas and technology. It builds on Boehringer Ingelheim’s commitment to early science and its comprehensive approach to respiratory research and development to investigate new treatments that have significant clinical value in areas of high unmet need.
https://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svg00hollandbiohttps://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svghollandbio2018-08-09 11:57:422018-08-14 11:58:54Boehringer Ingelheim takes its first step into gene therapy← #nieuws
Mooi nieuws: adaptive pricing van geneesmiddelen, waarbij de hoogte van vergoeding aan de onzekerheid en grootte van het effect aangepast wordt, wint aan draagvlak. In een interview in het NRC noemt niemand minder dan Martin van der Graaff (secretaris WAR, ZIN) adaptive pricing een logische regeling. HollandBIO popelt dan ook om deze oplossing uit haar “Sneller, Beter-programma” samen met het Zorginstituut en andere stakeholders verder uit te werken.
Vergoedingsbeslissingen leiden steeds vaker tot verhitte discussies. Vooral bij weesgeneesmiddelen is het keer op keer raak. Juist door de kleine patiëntengroepen is het voor weesgeneesmiddelen doorgaans lastig om aan de door het Zorginstituut gevraagde bewijslast te voldoen. En zolang er onzekerheid bestaat over de grootte van het effect, is vergoeding en toegang voor nieuwe patiënten geen uitgemaakte zaak. Een vicieuze cirkel, die duidt op een systeem dat vastloopt.
Adaptive pricing heeft alles in zich om deze impasse te doorbreken. Vanwege de kleine populaties en het minimaal beslag dat zij leggen op de zorgkosten (0,24% voor alle weesgeneesmiddelen totaal[1]) ziet HollandBIO in weesgeneesmiddelen de ideale proeftuin. Laten we daarom de handen ineen slaan en werk maken van deze oplossing waarbij gezondheidswinst, betaalbaarheid en innovatie hand in hand gaat.
[1] Zorginstituut, ´Monitor Weesgeneesmiddelen 2017’, 21 december 2017
https://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svg00Hollandbiohttps://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svgHollandbio2018-08-08 16:36:582018-08-08 16:36:58Adaptive pricing: van woorden naar daden← #nieuws
There’s a buzz among researchers across the Tasman as they recruit native Australian bees to fight the war on waste by helping create a new bioplastic.
The biotech start-up Humble Bee aims to take the nesting material from Banksia bees to produce a water-repellent and flame-resistant form of natural plastic. The New Zealand-based company is attempting to reverse engineer the material to create a biodegradable alternative on an industrial scale.
Founder and chief executive Veronica Harwood-Stevenson has been collecting Banksia bees (Hylius nubilosus) in south-east Queensland with the help of Chris Fuller from Kin Kin Native Bees. Her work involved trying to understand the cellophane-like bioplastic that lines the bees’ nest.
“They’re a small black bee, and if you keep an eye out for them you can see them in your backyards,” she told ABC Radio Brisbane’s Emma Griffiths.
“Chris supplies stingless bees to the macadamia industry, so his great knowledge on what material to do analysis on has helped us start.”
Ms Harwood-Stevenson said the idea came about when she was doing research on different science disciplines. “I have a strong interest in biology and I read an article on native bees and this bee lines its nests with material that looked promising,” she said.
“The author of the article made a throwaway comment that it behaved liked a plastic, and I knew that packaging was a leading cause of plastic pollution so I thought this could be part of the solution.”
Creating a new type of ‘natural plastic’
Along with a team of scientists, Ms Harwood-Stevenson said the aim was to make the product biologically.
Phil Lester, an entomologist and professor of biological science at Victoria University of Wellington, has been helping study the bees.
By examining their DNA, the researchers hope to identify the genes that give the bees the ability to make the special bioplastic.
“We will do a similar thing to how insulin was made in the 1970s — the gene that coded insulin was put into an E. coli bacteria and could then be produced en masse,” Ms Harwood-Stevenson said.
“You can’t take biological material in its entirety from Australia into New Zealand, so we did a dissection in Queensland and brought the parts of the bee we were interested in back to New Zealand.
“Any further work we do will be back in Australia due to the biological difficulty of going between the two countries.”
She said New Zealand didn’t have the native bee expertise or husbandry, which prompted her to travel to Australia.
“We had people in New Zealand who had done a lot of research, but where you could go to find them [the bees] was something that Australia had that we didn’t.”
An alternative to single-use plastic
Despite being in its early stages, Ms Harwood-Stevenson said creating a bioplastic was within reach.
“Plastic is a word that is like sport or religion; it encompasses so many different types of chemistry and so many materials with many properties and uses.”
Ms Harwood-Stevenson said a form of plastic would always be needed, not for single-use items, but for many industries it was a material that could not be substituted out.
“It has performance properties that make it important in many industries and you can’t just stop using it, given today’s society and the technology that we rely on.”
She said she hoped this form of bioplastic could fill the gap across industries and would like to see the material ready to sell in five years.
https://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svg00hollandbiohttps://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svghollandbio2018-08-06 13:13:252018-08-14 13:24:40How a humble Australian bee could help the world’s plastic problem← #nieuws
Scientists believe a new feed solution for Atlantic farmed salmon – created from a genetically modified plant – could help relieve pressure on stressed marine resources.
The University of Stirling, in collaboration with Rothamsted Research, is conducting a study into the potential benefits of using the customised feed to improve access to omega-3 fish oils, credited as being a key component of a balanced diet.
Wild fisheries – which currently provide the beneficial oils – are at their sustainable limits and, therefore, existing stocks are not able to provide enough of the beneficial omega-3 for a global population.
In a bid to tackle the issue, current practice involves giving farmed fish a feed blended with both marine fish oil, sourced from the sea, and vegetable oil. However, the new study could revolutionise the industry – and return levels of omega-3 fatty acids in farmed fish to the levels of a decade ago.
The research is jointly led by plant scientist Professor Johnathan Napier, from Rothamsted Research, and fish nutritionist Professor Douglas Tocher, of Stirling’s Institute of Aquaculture.
“The joint project allows us to culture salmon to market size in sea pens while extracting data to ensure new feeds support good growth, feed use and product quality”, Professor Tocher said.
Professor Napier added: “This is the largest feeding trial to validate the efficacy of the project. It’s extremely significant because it will demonstrate the ability to use omega-3 fish oils from plants across the whole production cycle of salmon.”
The study will see the farmed fish – which are not genetically modified (GM) – being given a feed which includes oils pressed from a GM oilseed crop plant, Camelina. The modified plant has high-levels of the beneficial omega-3 fatty acids, proving to be a safe and cost-effective source of these for aquaculture feeds.
During the course of the trial, Dr Monica Betancor, a Research Fellow at Stirling, will play a crucial role by checking on the salmons’ health and collecting data.
“Collecting samples and analysing the data are imperative to the project. To test the performance of the fish, I’ll be measuring the weight and growth of the fish, but also looking at tissue and molecular samples comparing results of fish fed the new fish feed to salmon fed a standard diet,” said Dr Betancor.
The project will both serve as a proof of concept and a potential solution to the sustainability issue in supplying fish oils to farmed fish.
Professor Napier has long been exploring how to develop a sustainable source of omega-3 using transgenic plants.
“It’s taken a decade to develop plants able to produce the oils and be used in aquaculture,” he said.
“This GM technology shows great promise as a potential solution to help fish farming remain even more sustainable while continuing to grow as an industry.”
Studies have suggested a link between omega-3 fish oils – also known as omega-3 long chain polyunsaturated fatty acids such as EPA and DHA- and benefits to human health.
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Marine Biodegradable Plastic
Voedsel en materialenBioLogiQ, recently announced that test results show its NuPlastiQ MB BioPolymer, produced by blending NuPlastiQ GP with PBAT (polybutylene adipate terephthalate), is marine biodegradable. Performed by Eden Research Laboratory, results show 97% biodegradation of a GP/PBAT film in ocean water within a one-year period, according to ASTM-D6691 standards for marine biodegradability.
The key to this innovative new plastic compound is BioLogiQ’s NuPlastiQ GP General Purpose BioPolymer. GP is a 100% natural, renewably-resourced, plant-based resin (derived from the excess starch produced–and usually discarded–during potato processing) that has been certified by TUV Austria to marine biodegrade in 28 days. When PBAT is mixed with NuPlastiQ GP, it will also biodegrade in marine environments.
“Our ability to produce a marine biodegradable film using a material that was previously not marine biodegradable is a huge technical accomplishment that can significantly reduce both plastic marine debris and the negative effects this debris can have in our oceans. Given the current concern regarding plastics and ocean pollution, we are working on NuPlastiQ MB marine biodegradable formulations of NuPlastiQ GP with polyethylene and polypropylene. Our target applications are drink cups, straws, lids, and grocery sacks,” said BioLogiO’s president and founder Brad LaPray. He also noted that because the ability for plastics to biodegrade in a marine environment is so new and unusual, acceptable certification standards do not exist and that the company plans to work with industry and governments to develop new standards.
HAL Allergy first company to achieve marketing authorisations in line with Therapieallergene Verordnung (TAV)
GezondheidHAL Allergy announced the registration of SUBLIVAC® Birch 40.000 AUN/ml and SUBLIVAC® Trees 40.000 AUN/ml in Germany. These are the first marketing authorisations granted by the Paul Ehrlich Institute following the German Therapieallergene‑Verordnung (TAV).
The TAV was initiated by the German Federal Ministry of Health on 14 November, 2008, and regulates the marketing authorisation requirements for frequent therapeutic allergens, in order to guarantee quality, effectiveness and safety.
“We are proud to be the first company that registers two products in line with the German Therapieallergene‑Verordnung”, says Harry Flore, CEO of HAL Allergy Group. “We acknowledge that the regulations set by the German authorities, are important for allergic patients in Germany, the largest European allergy market. Therefore, we were determined to register our sublingual birch and trees products. The studies to obtain these marketing authorisations are part of our extensive clinical development program and follow the new EMA requirements.”
The studies confirm that SUBLIVAC® Birch 40.000 AUN/ml shows significant and clinically relevant improvement for adults in all primary and secondary endpoints versus placebo.
Principal investigator Prof. Dr. Oliver Pfaar, Scientific Head at the Allergy Center Wiesbaden and Professor at the Medical Faculty Mannheim, University Heidelberg, Germany, also member of the Scientific Advisory Board of HAL Allergy Group explains: “In the phase II study we identified the optimal dose of allergen. Phase III demonstrated a strong clinical efficacy of 32% in the combined symptom and medication score, compared to placebo. There was a significant improvement in quality of life scores as well as important changes in immunoglobulins.”
Abbott opent nieuwe fabriek in Weesp
InnovatieklimaatAbbott opent woensdag officieel een nieuwe fabriek op haar productielocatie in Weesp. Met de opening van het nieuwe gebouw breidt de farmaceut de productie uit van dydrogesteron, een geneesmiddel dat wordt gebruikt om een progesteron-insufficiëntie bij vrouwen te behandelen.
De nieuwe fabriek vertegenwoordigt een totale investeringswaarde van 80 miljoen Amerikaanse dollar en bevat dezelfde moderne technologie als het reeds bestaande gebouw. Door deze investering verwacht Abbott haar totale productiecapaciteit met 60 procent te verhogen. Door deze investering blijft Abbott de grootste fabrikant van dydrogesteron in de wereld.
“We zien een toenemende vraag naar dydrogesteron in snelgroeiende landen zoals China, India en Rusland”, zegt Sieneke Bult, site director van Abbott’s fabriek in Weesp. “Een van de geneesmiddelen die we hier in Weesp met dydrogesteron produceren is levensreddend. Het heeft al een blijvende impact gehad op het leven van miljoenen vrouwen wereldwijd doordat het hen helpt zwanger te raken en te blijven.”
Groeiende vraag naar medicijnen
Vanwege een “groeiende vraag naar medicijnen van hoge kwaliteit” blijft Abbott continue investeren in het vergroten van haar productiecapaciteit in Weesp. Naast dydrogesteron produceert het bedrijf in deze plaats nog twee andere producten: Duphalac (lactulose) en Influvac (griepvaccin). In 2015 heeft Abbott een nieuwe influenza-fabriek gebouwd, die de productiecapaciteit vergrootte van 34 miljoen doses naar 54 miljoen doses.
Bron: Skipr
‘Niemand zal onze CRISPR-banaan willen’
Voedsel en materialenHoe de Europese regels rond genbewerking een poging om de banaan te redden torpederen.
Het valt niet op wanneer je in de supermarkt langs de goed gevulde schappen loopt, maar het gaat niet goed met de banaan. Ziektes tasten wereldwijd plantages aan. Eet je een banaan, dan is dat doorgaans een Cavendish. Het gros van de wereldhandel in gestoeld op die ene variëteit. ‘Het is een monocultuur van quasi genetisch identieke planten die jaarlijks vijftig miljoen ton bananen voortbrengt’, zegt Roel Sterken. Sterken is een biotech-ondernemer. In samenwerking met wetenschappers van de KU Leuven en het Vlaams Instituut voor Biotechnologie (VIB) werkte hij aan een start-up die met CRISPR-Cas9 bananen wou veredelen om ze beter bestand te maken tegen ziekte.
‘Tot ‘zwarte woensdag’’, zegt Sterken. Op woensdag 25 juli besliste het Europese Hof voor Justitie immers dat planten die het resultaat zijn van genbewerkingstechnieken zoals CRISPR-Cas9 onder de ggo-wetgeving vallen en dus dezelfde strenge en dure markttoelatingsprocedure moeten doorlopen als genetisch gemodificeerde gewassen. ‘Sindsdien is ons initiatief een doodgeboren kind’, aldus Sterken. ‘Dat is niet alleen jammer voor ons, maar ook voor miljoenen lokale boeren in meer dan 120 landen die afhankelijk zijn van de banaan.’
Vijftig keer sproeien
De wereldwijde monocultuur maakt de banaan kwetsbaar. Twee ziektes bedreigen de bananenhandel. ‘De Panamaziekte is een schimmelziekte van de wortels die de planten doet afsterven’, zegt Sterken. ‘Daar is niets tegen te beginnen. Een aangetaste plantage wordt in quarantaine geplaatst en is verloren voor toekomstige bananenteelt. In de Filipijnen, één van de grootste bananenproducenten ter wereld, is in sommige gebieden meer dan de helft van de plantages verloren gegaan.’
‘De tweede ziekte, Black Sigatoka, is een bladschimmel. Die is wel onder controle te houden, maar enkel door intensief gebruik van fungiciden. De gemiddelde plantage wordt 50 maal per jaar besproeid.’
Sterken ziet in CRISPR-Cas9 een mogelijke oplossing. ‘Er bestaan bananenvariëteiten die resistent zijn tegen Black Sigatoka of de Panamaziekte. Ze zijn echter niet commercieel interessant: ze brengen te weinig op, rijpen te snel of smaken niet lekker. De resistentie overbrengen naar de Cavendish via klassieke veredeling kan niet, want de bananenplanten zijn steriel en worden door stekken vermeerderd. Wil je opnieuw vertrekken van de oerbanaan om tot een commercieel interessante banaan mét resistentie te komen, dan ben je minstens vijftig jaar zoet. Wat we wel kunnen doen is kijken welke genetische verschillen aan de basis liggen van de resistentie. Met CRISPR zou je de genetische code van de Cavendish vervolgens zo kunnen aanpassen dat ze identiek is aan die van de resistente variëteit.’
De hele wereld volplanten met dezelfde banaan, is dat niet om problemen vragen? ‘Die situatie is het gevolg van het feit dat geen enkele andere variëteit even geschikt is voor export als de Cavendish en veredeling zo moeilijk is’, zegt Rony Swennen, bananenexpert aan de KU Leuven en ook bij het initiatief betrokken. ‘Was dat niet zo, dan zouden er net zoals bij appels verschillende variëteiten op de markt kunnen komen. Ook daar zou CRISPR bij kunnen helpen.’
Bron: EOS wetenschap
FDA approves first-of-its kind targeted RNA-based therapy
GezondheidThe Food and Drug Administration approved Alnylam’s patisiran for the treatment of peripheral nerve disease (polyneuropathy), which is caused by hereditary transthyretin-mediated amyloidosis (hATTR). This is the first FDA-approved treatment for patients with polyneuropathy caused by hATTR, a rare, debilitating and often fatal genetic disease characterized by the buildup of abnormal amyloid protein in peripheral nerves, the heart and other organs. It is also the first FDA approval of a new class of drugs called small interfering ribonucleic acid (siRNA) treatment.
“This approval is part of a broader wave of advances that allow us to treat disease by actually targeting the root cause, enabling us to arrest or reverse a condition, rather than only being able to slow its progression or treat its symptoms. In this case, the effects of the disease cause a degeneration of the nerves, which can manifest in pain, weakness and loss of mobility,” said FDA Commissioner Scott Gottlieb, M.D. “New technologies like RNA inhibitors, that alter the genetic drivers of a disease, have the potential to transform medicine, so we can better confront and even cure debilitating illnesses. We’re committed to advancing scientific principles that enable the efficient development and review of safe, effective and groundbreaking treatments that have the potential to change patients’ lives.”
RNA acts as a messenger within the body’s cells, carrying instructions from DNA for controlling the synthesis of proteins. RNA interference is a process that occurs naturally within our cells to block how certain genes are expressed. Since its discovery in 1998, scientists have used RNA interference as a tool to investigate gene function and its involvement in health and disease. Researchers at the National Institutes of Health, for example, have used robotic technologies to introduce siRNAs into human cells to individually turn off nearly 22,000 genes.
This new class of drugs, called siRNAs, work by silencing a portion of RNA involved in causing the disease. More specifically, Onpattro encases the siRNA into a lipid nanoparticle to deliver the drug directly into the liver, in an infusion treatment, to alter or halt the production of disease-causing proteins.
Affecting about 50,000 people worldwide, hATTR is a rare condition. It is characterized by the buildup of abnormal deposits of protein fibers called amyloid in the body’s organs and tissues, interfering with their normal functioning. These protein deposits most frequently occur in the peripheral nervous system, which can result in a loss of sensation, pain, or immobility in the arms, legs, hands and feet. Amyloid deposits can also affect the functioning of the heart, kidneys, eyes and gastrointestinal tract. Treatment options have generally focused on symptom management.
Onpattro is designed to interfere with RNA production of an abnormal form of the protein transthyretin (TTR). By preventing the production of TTR, the drug can help reduce the accumulation of amyloid deposits in peripheral nerves, improving symptoms and helping patients better manage the condition.
“There has been a long-standing need for a treatment for hereditary transthyretin-mediated amyloidosis polyneuropathy. This unique targeted therapy offers these patients an innovative treatment for their symptoms that directly affects the underlying basis of this disease,” said Billy Dunn, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research.
The efficacy of Onpattro was shown in a clinical trial involving 225 patients, 148 of whom were randomly assigned to receive an Onpattro infusion once every three weeks for 18 months, and 77 of whom were randomly assigned to receive a placebo infusion at the same frequency. The patients who received Onpattro had better outcomes on measures of polyneuropathy including muscle strength, sensation (pain, temperature, numbness), reflexes and autonomic symptoms (blood pressure, heart rate, digestion) compared to those receiving the placebo infusions. Onpattro-treated patients also scored better on assessments of walking, nutritional status and the ability to perform activities of daily living.
The most common adverse reactions reported by patients treated with Onpattro are infusion-related reactions including flushing, back pain, nausea, abdominal pain, dyspnea (difficulty breathing) and headache. All patients who participated in the clinical trials received premedication with a corticosteroid, acetaminophen, and antihistamines (H1 and H2 blockers) to reduce the occurrence of infusion-related reactions. Patients may also experience vision problems including dry eyes, blurred vision and eye floaters (vitreous floaters). Onpattro leads to a decrease in serum vitamin A levels, so patients should take a daily Vitamin A supplement at the recommended daily allowance.
The FDA granted this application Fast Track, Priority Review and Breakthrough Therapy designations. Onpattro also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.
Approval of Onpattro was granted to Alnylam Pharmaceuticals, Inc.
Source: FDA
Celebrating European Biotech Week 2018
Gezondheid, InnovatieklimaatEuropaBio is delighted to announce European Biotech Week 2018. Between 24 – 30th of September, the EU will, for the sixth time, witness a week packed full of biotech-focused activities and events. European Biotech Week will be held alongside simlar initiatives, planned across 4 continents as part of Global Biotech Week.
This year, we build on the success of European Biotech Week 2017, where a record-breaking number of 19 European countries held over 150 events and activities. This annual initiative, aimed at increasing dialogue around and understanding of biotech, comprises of a diverse set of activities that include open doors visits, symposiums, round table discussions, fun runs, flashmobs, competitions, roving labs, theatre plays, hands-on experiments and much more.
Commenting on the event, Chair of EuropaBio, Tjerk de Ruiter, said “Biotech has been benefitting people and planet for many years now, providing solutions to some of society’s most pressing challenges. It helps us to use our resources more efficiently, provides food and feed for a growing population and develops treatments for unmet medical needs. In biotech week, we take time out to celebrate these acheivements, together with a growing community of biotech enthusiasts of all ages and nationalities.’’
He concluded: ‘’One of the best things about the events that this week brings together is the creativity on show and the shared passion and enthusiasm for communicating on biotech. In the EU, we have a wealth of success stories to share which are being created by the young people studying biotech and by those innovating in this field. Ultimately, they are the ones who make Biotech week the success that it is’’
“We invite you to see what is going on near you on www.biotechweek.org and www.globalbiotechweek.ca, and we wholeheartedly thank all the biotech supporters who have contributed to this year’s amazing programme already. Lastly, it’s not too late to hold your own events to show why there is no science like biotech science!”
Source: EuropaBIO
Boehringer Ingelheim takes its first step into gene therapy
GezondheidThe company have together with the UK Cystic Fibrosis Gene Therapy Consortium (GTC), consisting of Imperial College London and the Universities of Oxford and Edinburgh, Imperial Innovations, and Oxford BioMedica (OXB) announced a global collaboration to develop a first-in-class, long-term therapy for patients with cystic fibrosis (CF).
The new partnership brings together the academic partners’ leading expertise in developing gene therapy for CF and OXB’s leading expertise in manufacturing lentiviral vector-based therapies with Boehringer Ingelheim’s capabilities in drug discovery and the clinical development of novel breakthrough therapeutic agents, reports the collaborators.
A possible universal treatment option
The collaboration will focus on a novel approach using a replication-deficient lentiviral vector in an inhaled formulation, to introduce a healthy copy of the CFTR gene into the cells of the lung. This method has demonstrated high gene transfer efficiency and offers the possibility of repeated administration to maintain the therapeutic effect. Gene therapy is the only therapeutic approach to date that can address all CFTR gene mutations, thus potentially offering a universal treatment option.
Three-way partnership
“This novel three-way partnership brings together an unparalleled combination of clinical, scientific, manufacturing and commercial skills in an effort to develop new treatments and make a major contribution to the lives of patients affected by cystic fibrosis,” stated John Dawson, Chief Executive Officer of Oxford BioMedica. “The GTC has been working determinedly for over 15 years to get to this exciting point of forming a partnership with Boehringer Ingelheim, a global pharmaceutical company with respiratory expertise. Our contribution to this partnership reaffirms our leading position in the development and manufacturing of lentiviral vector gene therapy products at large scale. We look forward to working with our new academic and industry partners.”
“Through this collaboration, we are joining forces with some of the top talents in this disease space to propel treatment advances forward,” said Clive R. Wood, Ph.D., Senior Corporate Vice President, Discovery Research at Boehringer Ingelheim. “Bringing together our existing expertise as a leader for nearly a century in the discovery and development of therapies that have advanced patient care in respiratory diseases with the gene therapy knowledge of our partners, we aim to unlock unprecedented opportunities for patients with this devastating disease, who are desperately waiting for better treatment options.”
Collaboration details
Boehringer Ingelheim has received an option to license the exclusive global rights to develop, manufacture, register, and commercialise this lentiviral vector-based gene therapy for the treatment of cystic fibrosis. Financial terms are not disclosed. During the option period the partners will work closely together to pursue the development of this innovative approach financed by Boehringer Ingelheim. The new collaboration is a joint initiative of Boehringer Ingelheim’s Respiratory Therapeutic Area and Research Beyond Borders (RBB), which is one of the pillars of Boehringer Ingelheim’s research and development strategy and explores emerging science, disease areas and technology. It builds on Boehringer Ingelheim’s commitment to early science and its comprehensive approach to respiratory research and development to investigate new treatments that have significant clinical value in areas of high unmet need.
Source: Nordic life science
Adaptive pricing: van woorden naar daden
Gezondheid op maat, Hollandbio, GezondheidMooi nieuws: adaptive pricing van geneesmiddelen, waarbij de hoogte van vergoeding aan de onzekerheid en grootte van het effect aangepast wordt, wint aan draagvlak. In een interview in het NRC noemt niemand minder dan Martin van der Graaff (secretaris WAR, ZIN) adaptive pricing een logische regeling. HollandBIO popelt dan ook om deze oplossing uit haar “Sneller, Beter-programma” samen met het Zorginstituut en andere stakeholders verder uit te werken.
Vergoedingsbeslissingen leiden steeds vaker tot verhitte discussies. Vooral bij weesgeneesmiddelen is het keer op keer raak. Juist door de kleine patiëntengroepen is het voor weesgeneesmiddelen doorgaans lastig om aan de door het Zorginstituut gevraagde bewijslast te voldoen. En zolang er onzekerheid bestaat over de grootte van het effect, is vergoeding en toegang voor nieuwe patiënten geen uitgemaakte zaak. Een vicieuze cirkel, die duidt op een systeem dat vastloopt.
Adaptive pricing heeft alles in zich om deze impasse te doorbreken. Vanwege de kleine populaties en het minimaal beslag dat zij leggen op de zorgkosten (0,24% voor alle weesgeneesmiddelen totaal[1]) ziet HollandBIO in weesgeneesmiddelen de ideale proeftuin. Laten we daarom de handen ineen slaan en werk maken van deze oplossing waarbij gezondheidswinst, betaalbaarheid en innovatie hand in hand gaat.
[1] Zorginstituut, ´Monitor Weesgeneesmiddelen 2017’, 21 december 2017
How a humble Australian bee could help the world’s plastic problem
Voedsel en materialenThere’s a buzz among researchers across the Tasman as they recruit native Australian bees to fight the war on waste by helping create a new bioplastic.
The biotech start-up Humble Bee aims to take the nesting material from Banksia bees to produce a water-repellent and flame-resistant form of natural plastic. The New Zealand-based company is attempting to reverse engineer the material to create a biodegradable alternative on an industrial scale.
Founder and chief executive Veronica Harwood-Stevenson has been collecting Banksia bees (Hylius nubilosus) in south-east Queensland with the help of Chris Fuller from Kin Kin Native Bees. Her work involved trying to understand the cellophane-like bioplastic that lines the bees’ nest.
“They’re a small black bee, and if you keep an eye out for them you can see them in your backyards,” she told ABC Radio Brisbane’s Emma Griffiths.
“Chris supplies stingless bees to the macadamia industry, so his great knowledge on what material to do analysis on has helped us start.”
Ms Harwood-Stevenson said the idea came about when she was doing research on different science disciplines. “I have a strong interest in biology and I read an article on native bees and this bee lines its nests with material that looked promising,” she said.
“The author of the article made a throwaway comment that it behaved liked a plastic, and I knew that packaging was a leading cause of plastic pollution so I thought this could be part of the solution.”
Creating a new type of ‘natural plastic’
Along with a team of scientists, Ms Harwood-Stevenson said the aim was to make the product biologically.
Phil Lester, an entomologist and professor of biological science at Victoria University of Wellington, has been helping study the bees.
By examining their DNA, the researchers hope to identify the genes that give the bees the ability to make the special bioplastic.
“We will do a similar thing to how insulin was made in the 1970s — the gene that coded insulin was put into an E. coli bacteria and could then be produced en masse,” Ms Harwood-Stevenson said.
“You can’t take biological material in its entirety from Australia into New Zealand, so we did a dissection in Queensland and brought the parts of the bee we were interested in back to New Zealand.
“Any further work we do will be back in Australia due to the biological difficulty of going between the two countries.”
She said New Zealand didn’t have the native bee expertise or husbandry, which prompted her to travel to Australia.
“We had people in New Zealand who had done a lot of research, but where you could go to find them [the bees] was something that Australia had that we didn’t.”
An alternative to single-use plastic
Despite being in its early stages, Ms Harwood-Stevenson said creating a bioplastic was within reach.
“Plastic is a word that is like sport or religion; it encompasses so many different types of chemistry and so many materials with many properties and uses.”
Ms Harwood-Stevenson said a form of plastic would always be needed, not for single-use items, but for many industries it was a material that could not be substituted out.
“It has performance properties that make it important in many industries and you can’t just stop using it, given today’s society and the technology that we rely on.”
She said she hoped this form of bioplastic could fill the gap across industries and would like to see the material ready to sell in five years.
Source: ABC
GM Plants Could Provide Balanced Diet for Salmon
Voedsel en materialenScientists believe a new feed solution for Atlantic farmed salmon – created from a genetically modified plant – could help relieve pressure on stressed marine resources.
The University of Stirling, in collaboration with Rothamsted Research, is conducting a study into the potential benefits of using the customised feed to improve access to omega-3 fish oils, credited as being a key component of a balanced diet.
Wild fisheries – which currently provide the beneficial oils – are at their sustainable limits and, therefore, existing stocks are not able to provide enough of the beneficial omega-3 for a global population.
In a bid to tackle the issue, current practice involves giving farmed fish a feed blended with both marine fish oil, sourced from the sea, and vegetable oil. However, the new study could revolutionise the industry – and return levels of omega-3 fatty acids in farmed fish to the levels of a decade ago.
The research is jointly led by plant scientist Professor Johnathan Napier, from Rothamsted Research, and fish nutritionist Professor Douglas Tocher, of Stirling’s Institute of Aquaculture.
“The joint project allows us to culture salmon to market size in sea pens while extracting data to ensure new feeds support good growth, feed use and product quality”, Professor Tocher said.
Professor Napier added: “This is the largest feeding trial to validate the efficacy of the project. It’s extremely significant because it will demonstrate the ability to use omega-3 fish oils from plants across the whole production cycle of salmon.”
The study will see the farmed fish – which are not genetically modified (GM) – being given a feed which includes oils pressed from a GM oilseed crop plant, Camelina. The modified plant has high-levels of the beneficial omega-3 fatty acids, proving to be a safe and cost-effective source of these for aquaculture feeds.
During the course of the trial, Dr Monica Betancor, a Research Fellow at Stirling, will play a crucial role by checking on the salmons’ health and collecting data.
“Collecting samples and analysing the data are imperative to the project. To test the performance of the fish, I’ll be measuring the weight and growth of the fish, but also looking at tissue and molecular samples comparing results of fish fed the new fish feed to salmon fed a standard diet,” said Dr Betancor.
The project will both serve as a proof of concept and a potential solution to the sustainability issue in supplying fish oils to farmed fish.
Professor Napier has long been exploring how to develop a sustainable source of omega-3 using transgenic plants.
“It’s taken a decade to develop plants able to produce the oils and be used in aquaculture,” he said.
“This GM technology shows great promise as a potential solution to help fish farming remain even more sustainable while continuing to grow as an industry.”
Studies have suggested a link between omega-3 fish oils – also known as omega-3 long chain polyunsaturated fatty acids such as EPA and DHA- and benefits to human health.
Source: technology networks