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Oss, The Netherlands, April 8, 2019.

BioConnection will invest €12 million in a second, commercial scale, manufacturing line to keep up with the growing customer demand and to ensure its future company growth.

BioConnection, Contract Manufacturing Organization (CMO), proudly announces that it will make a significant investment of €12 million in a new production line for vials in its facility in Oss. Due to the growing demand of its current customers but also due to growing market needs, BioConnection will invest in a fully automated fill and finish line coupled to a fully automated freezedryer. This combination provides significant increases in batch size as well as in total annual production capacity. BioConnection currently is inspected and approved by EMA and US-FDA. The new production line will also be built and validated according to EMA and FDA guidelines and is expected to be fully operational, including GMP certification, in the first quarter of 2021. In the meantime the company will continue to grow on the basis of its existing filling line for vials, syringes and freeze-drying. BioConnection also recently announced (March 13, 2019) the opening of new flexible GMP areas for manual fill, rental of cleanrooms and support of ATMP’s to enable an even more flexible approach for their customers.

Dr. Alexander Willemse, CEO of BioConnection: “Although BioConnection is already 13 years young, the last 3 years have been exciting when we took over our current manufacturing facility from Merck/MSD in 2016. Based on the success of our customers and the growing market demand we will now take a major step forward by adding this new production line. I am convinced that we will further dynamically grow the company while maintaining our unique approach. The enthusiasm and spirit of our team coupled to the experience of our business development, project management, operational, technical and quality people we have on board will make it a continued success. I invite all interested companies to contact Sjaak Stevense to discuss possibilities and early transfers to our new commercial scale production line. Where needed we can already start of to date with fill and finish and freeze-drying services through our current (smaller scale) FDA certified production line

If you want to learn what we can do for your product or project, contact us or visit our (new) website.

About BioConnection B.V.

BioConnection B.V. (www.bioconnection.eu) is a Dutch CMO which offers flexible state-of-the-art development and GMP compliant manufacturing services for sterile Drug Products in batch sizes ranging from a few vials (manual fill) up to 18.000 vials (automated fill). BioConnection is specialized in Fill and Finish including freeze drying, technology transfers, scale-up and validations. BioConnection offers complete Drug Product manufacture service packages based on tailor made solutions and customer-oriented flexibility from its own facility in Oss (which is EMA and US FDA certified) in cooperation with various best-in-class partners. BioConnection supplies its clients (since 2005) with injectable Drug Products (e.g. vials and syringes) for either clinical trial programs and/ or commercial purposes.

If you want to learn more about how BioConnection can bring value to your projects, please contact us.

Alexander Wilemse, PhD

Alexander Wilemse, PhD

CEO

Sjaak Stevense, MD

Sjaak Stevense, MD

Director of Commercial Productions

Marco Jaspers, PhD

Marco Jaspers, PhD

Director Program Management & Business Development

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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