Oss, The Netherlands, March 13, 2019.
BioConnection opens this month, after an intensive engineering and validation program its Flexible GMP area. The area consists of several small scale cleanrooms ranging from class B up to class D. The Flexible GMP area is located on the 5th floor in its GMP facility in Oss, The Netherlands. Embedded in a GMP environment (with a track record of more than 14 years) and supported by a crew of GMP compliant trained operators, the Flexible GMP area provides several opportunities for clients such as:
- Manual Fill (class A, aseptic) of liquids and suspensions;
- Early stage manufacturing process development (for Drug Products);
- Assembly projects (under GMP conditions);
- Support of ATMP and BSL-2 projects;
- Cleanroom rental.
On March 12, 2019 the Manual Fill (class A) production unit passed an inspection from the Dutch Healthcare Inspectorate (IGJ). Initial productions slots have already been confirmed by clients for coming April. Besides small scale aseptic manual filling in standard vial formats (up to around 1,000 units) also other formats such as bottles and bags can be processed.
Dr. Alexander Willemse, CEO of BioConnection: “We are very excited to open this Flexible GMP area in our facility for which there is a clear market need. Moreover it is also a logic addition to our existing business as we can now provide our clients with even more flexibility and a greater window of service opportunities. Besides the contemporary aseptic manual filling of (bio)pharmaceutical products we can now offer clients also support for their novel ATMP and BLS-2 projects; in addition we offer the possibility to rent (some of) the GMP cleanrooms in the Flexible GMP area”
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.