Pepscan’s GMP production capacity has doubled. Pepscan is an all-in-one partner in peptides, building on 25 years of experience in advancing and applying peptide expertise to facilitate clients in the development and production of peptides. The doubled GMP production capacity enables Pepscan to guarantee short production timelines. It also gives clients the benefit of collaborating with a single expert partner on the way from R&D to the clinic, resulting in maximum efficiency while also saving time. Specifically, researchers active in personalized peptide medicine, where both timelines and flexibility are key, will benefit from these new developments.

Hans de Backer, CEO of Pepscan, explains the new capacity additions. “Earlier this year, we started producing GMP peptides for clinical studies phases 1 and 2, which made it possible to provide peptides for purposes beyond R&D: directly for the benefit of patients. Our new production line, consisting of a new synthesizer, a preparative HPLC and lyophilizer in our cleanroom, and the strengthened QMS and process documentation that were put in place for this, have proven to facilitate the efficient execution of the process. Using this proven concept, we have now doubled the complete production line.” Current production includes both therapeutic peptide projects as well as personalized peptide medicine projects (e.g. neoantigen vaccines).

“Given our role in the field of personalized medicine, short and reliable delivery times are crucial,” adds Hanne Kho, Chief Operations Officer of Pepscan. “This demands a set of rigorous processes and a certain level of flexibility that we, together with outstanding product quality, are able to deliver. I’m very proud that the recent GMP customer audits that were conducted have confirmed this.”

De Backer continues, “Doubling our GMP production capacity is a major milestone that transforms our newly developed GMP capabilities into a solid pillar of our peptide services portfolio. In the last 25 years, we have built extensive knowledge and a reputation for our expertise in developing and producing peptides, specifically constrained peptides.  I’m glad that we are now able to use this expertise to provide peptides for purposes beyond R&D: directly for the benefit of patients.”

Source: Pepscan

Every year, an estimated 300.000 hemodialysis patients worldwide die as they run out of medical alternatives. One of the main reasons for these deaths is failure of the vascular access site, the blood vessel where blood is removed, filtered and returned to the body during dialysis. To solve this problem, a medical device was developed that enables a patient’s body to create blood vessels using the patient’s own cells. Vacis, the company commercializing this technology, has successfully closed a further funding round to set up GMP production, execute clinical trials and obtain CE certification.

The company received funding from Netherlands-based Brightlands Venture Partners and LIOF through their Limburg Business Development Fund (LBDF), as well as the German High-Tech Gründerfonds (HTGF). This was supplemented with a so-called Innovation Credit from RVO (the Netherlands Enterprise Agency). “The financing and support of the investors will enable us to quickly scale up the clinical trial and accelerate the route to market by at least a year”, says Ken Messier.

“Vacis combines elegant science with a solid management team. Brightlands truly is the ecosystem in which Vacis can validate its technology in patients and go to market fast.”, says Casper Bruens – Director at Brightlands Venture Partners. Tys van Elk, Director at LIOF adds: “Vacis is an exciting addition to the local community of regenerative medicine and realizing this consortium fits perfectly with LIOF’s increasing cross border ambition in the Euregio.”

The medical device is a synthetic rod with a specialized surface that is inserted under the skin. This induces the body to form a tissue capsule, which in the right environment, further matures into a functional blood vessel that is used as a vascular access site for hemodialysis. “We found the simplicity of the solution and the biocompatibility data very convincing and are delighted to support Vacis” adds Anke Cassing, Investment Manager at HTGF.

The team has been expanded with two seasoned biotech managers, Ken Messier and Josephine Brackman. Ken brings a wealth of clinical development and regulatory expertise, with over 30 years’ experience in Biotech. He has held various Director and Sr. Program Management positions within biotech companies such as Genzyme and DSM Biomedical. Josephine brings a broad expertise that covers (project) management, intellectual property and R&D. She has over 25 years’ experience in materials and biotech and has held several senior positions within DSM. They both join Dominik Klump, the Chief Technology Officer of Vacis, in the management team at the location in Geleen.

Leiden University Medical Center and Maastricht University played a key role in the development of the technology. The project was also supported by The Dutch Kidney Patients Association and the Biomedical Materials Program (BMM), a public-private partnership of leading industrial and academic players and the Dutch government.

Source: Vacis