PharmaCell was founded in 2005 as a Contract Manufacturing Organisation in Europe for Cell Therapy and Regenerative Medicine supporting Phase I to Phase III clinical trial and support launch commercialization for European market.
PharmaCell has a license for manufacturing ATMPs in clinical trials and is solely focussing on Cell Therapy and Regenerative Medicine. Their experience ranges from clinical trials from Phase I to preparation for commercial manufacturing. PharmaCell can ensure manufacturing up to commercial stage.
PharmaCell’s Cell Therapy CMO services include:
- Thorough transfer of technologies, using a Technology Transfer Scan System
- Process development expertise, including cell culture scale-up
- Design and Validation of aseptic cell processing in class B environment
- Thorough assessments in case of conditional release (when safety data or not fully available) -Manufacturing of autologous, allogeneic, adherent and suspension cell types
- In-house Cell Assay QC tests, including FACS analysis
- QP release of products for the EU market, including parametric release
- Flawless controlled temperature transportation worldwide, including assistance in design and validation of controlled transportation of cell material.
Collaborations in research consortia and industrial partners/suppliers to promote platforms for centers of excellence in ATMPs, participate in grants to promote, accelerate implementation of automation-, upscaling-, formulation devices in GMP compliant manufacturing of ATMPs.
Lead Scientist: Dr. Sönke Brunswieck
Institution: Pharmacell BV
Position: Head of Business Development and Project Management
Address: The Netherlands
The planned work will be lead be Sönke Brunswieck. Sönke is head of Business Development and Project Management at PharmaCell. He has 15 years international marketing, sales and business development experience covering the full range of Life Science industry – Pharmaceutical, Diagnostic, Medical Device and Biotechnology Industry.
The planned work will be executed by several disciplines within PharmaCell. Business Development will be involved in setting-up contacts with clinical trialist. Quality Assurance and Technology development will assist in preparation of the training program.
Tasks: Mr Brunswieck has expertise in commercial manufacture of ATMPs and participates in WP2, WP3 and WP4.