Oss, The Netherlands, 29 November 2021
BioConnection, an independent CDMO (Contract Development Manufacturing Organization) based in Oss, The Netherlands, specialized in GMP-certified manufacturing of sterile drug products in vials and syringes, today announced that Nykode Therapeutics AS, (formerly Vaccibody) (Euronext Growth Oslo: VACC), selected BioConnection for the aseptic drug product manufacturing of its lead vaccine candidate. Nykode Therapeutics AS is a clinical stage biotechnology company, developing vaccines and novel immunotherapies for the treatment of cancer and infectious diseases with a high unmet medical need.
Mette Husbyn, CTO of Nykode Therapeutics, said:
“We chose to partner with BioConnection for the manufacturing of Nykode Therapeutics’ precious clinical trial material because of their tailored solutions for production, matching the requirements for small scale batches. Moreover, BioConnection has an excellent broad manufacturing and regulatory track record, including EMA and FDA certification.”
BioConnection’s CEO Alexander Willemse adds:
“Phase I trials usually require small batches of drug products that have to be delivered in a precise manner. Capitalizing on our years of experience, we offer automated filling in large volumes up to 40 million vials per year, and importantly also manual fill and finish. I’m very happy that our manufacturing capabilities, perfectly match Nykode Therapeutics’ exact early phase clinical trial needs.”
BioConnection, based in Oss, The Netherlands, is a contract manufacturer for the GMP production of sterile drug products (in vials or syringes) for clinical trial programs and commercial purposes. Its state-of-the-art GMP manufacturing facility is EMA and US-FDA certified, the company has more than fifteen years of experience and serves a global customer base. BioConnection offers complete drug product service packages, including filling and freeze drying, technical transfer, scale-up, process validation, analytical support, stability studies, label & pack (incl. serialization) and final batch certification to clinic or market. Delivering from four aseptic filling lines (class A), BioConnection can match quantities that are required for personalized medications, clinical trial programs and commercial purposes.
Recently, BioConnection has been granted GMP Certification for production of sterile drug products on their brand new large scale filling line, significantly increasing its production capacity and thus ensuring future company growth. The new production line, which has been validated as per the EMA and US-FDA quality guidelines, has an annual production capacity of up to 40 million vials for liquid products and up to 4 million vials for freeze-dried products.