Since BioConnection has state-of-the-art facilities, we can offer the best conditions for GMP Manufacturing or Personalized Medicines.
BioConnection offers state-of-the-art GMP manufacturing facilities and a broad range of support services. BioConnection operates from its proprietary FDA and EMA approved facility in Oss, the Netherlands. From this facility, we can provide you with clinical scale manufacturing in a wide variety of formats and techniques, including freeze-drying. Besides our expertise in development and manufacturing of clinical trial medication, we are your partner in proven track-record for global commercial manufacturing for small indications and orphan drugs. This is a unique proposition where you can rely on our experienced team and AAA-class facility.
As per 2019, BioConnection offers new cleanrooms for Advanced Therapy Medicinal Products (ATMP) manufacturing, including Personalized Medicines and cell-based therapies (BSL2 classification). These areas can also be rented for (short) terms to, for example, your complex production process.
BioConnection has multi-purpose suites (GMP grade D to A) which can be used to perform GMP activities upon your specification. We can either perform these steps for you, or you can rent these areas for (short) terms for example for Medical Device projects requiring a GMP process step.
Since 2019 BioConnection also offers manual filling for small scale batches and/or custom size vials or other primary packs within our state-of-the-art GMP manufacturing facilities. The actual fill is performed in a grade A cabinet, situated in a Grade B environment. All product contact components are disposable or dedicated, allowing us to work with a wide range of different products. Manufacturing on this line can also be completed with and a broad range of BioConnection support services.
Summary of our services
Drug product development
- Formulation development
- Process and analytical development & validation
- Lyo-cycle development and/or optimization
- Transfer and scale-up to clinic
- Transfer and scale-up to market
- Shelf areas ranging from 3 m² up to 10 m²
Clinical trial material services
- Clinical trial packaging
- QP release
Fill and Finish
- Batch sizes: from 1 unit up to 161,000 units per batch
- Clinical and commercial scale
- Automated fill and hand fill
- Aseptic filling
- Vials: from 2 RDIN up to 50 RDIN
- Syringes: from 0.5 ml up to 10 ml
- Other primary packs: via handfill
- Terminal sterilization