Friday, November 22, 2024

BioConnection to manufacture clinical trial material for Nykode Therapeutics’ vaccine

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, announced that Nykode Therapeutics AS, (formerly Vaccibody) (Euronext Growth Oslo: VACC), selected BioConnection for the aseptic drug product manufacturing of its lead vaccine candidate.

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Nykode Therapeutics 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, said:

“We chose to partner with BioConnection for the manufacturing of Nykode’s 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’s exact early phase clinical trial needs.”

About BioConnection

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.

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