Drug Substance
In our state-of-the-art GMP, mammalian cell based production facility, we offer a wide range of upstream technologies, stainless steel and single-use production lines and two independent purification lines in a fully automated facility, providing flexibility to meet your requirements in technology transfer, production and GMP- compliant documentation. Our facility is operated by experienced professionals to provide high quality services and customized solutions for your needs. Our experts in microbial-derived biopharmaceuticals are Richter-Helm Biologics in Hamburg, Germany.
Equipment, systems available
- Stainless steel bioreactors (1000L and 2x5000L) for large volume commercial scale production.
- Single-use technology (SUT) bioreactors (4x2000L ) for fast and cost-effective production of different products.
- 250L & 500L single-use bioreactors for initial development, clinical and scale-up batches.
- Flexible purification facility to meet any purification need.
- Process automation system (PAS): provides compliance, full control and reliability for every batch.
Process capabilities
- 2 x different DCS systems (ABB & Delta V)
- Recipe driven technology