Covid update

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.”

 

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.

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.

Contacts

BioConnection, Oss,
The Netherlands
Alexander Willemse, CEO
T: +31 412 637 937
Send a mail

For Media

LifeSpring LifeSciences Communication, Amsterdam,
The Netherlands
Leon Melens
T: +31 6 538 16 427
Send a mail

bioconnection

Covid-19 update BioConnection

BioConnection has taken precautions related to the global outbreak of the Covid-19 virus. To start with; we are currently in full operation and running on-schedule with regard to our planned productions. Our production department is on full strength and we have no shortages of material(s) nor do we foresee them.

For our personnel we are following the guidelines as issued by the Dutch National Institute for Public Health and the Environment, RIVM (www.rivm.nl). This means that people stay at home when they show (early) symptoms connected to Covid-19. Furthermore BioConnection employees work from home as much as possible. We avoid shaking hands and keep distance from each other. We take every precaution as advised to prevent the spread of the Covid-19 virus and will fully comply to the requests as stated and/or enforced by the authorities.

Our expansion project (expansion.bioconnection.eu) is running as planned to start GMP production in Q2 2021. We stay in close contact with our suppliers for the production equipment.

We review for Covid policy changes by the authorities on a daily base and adapt to them. If changes occur, this statement will be updated accordingly so you always have the latest information. In case you have any questions, please do not hesitate to contact us via our general number or website. Current customers of BioConnection, can contact their dedicated program manager. In case you want BioConnection to become a partner in your development or manufacturing, please contact our Business Development department via contact@bioconnection.eu.

The BioConnection Management Team.

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