Upstream & Downstream Process Development
A Broad Range of Expertise From Early to Late Phase Clinical Programs
No matter what phase in the development journey, opportunities for process improvements are ever-present. With the knowledge that a well-defined, scalable process will certainly lend itself well to acceleration through the remaining phases of pharmaceutical or biotech development, the time is now to ensure your processes are not only compliant, but also commercially viable.
At ProPharma Group, we offer a broad range of expertise in upstream and downstream bioprocessing within the different Chemistry, Manufacturing, and Control (CMC) development stages from early to late phase clinical programs. Products supported include (recombinant) proteins, monoclonal antibodies, biosimilars, Antibody Drug Conjugates (ADC), and Advanced Therapy Medicinal Products (ATMPs) including cell therapy and gene therapy.
Additionally, we provide solutions for facility modifications and improvement of plant output by applying principles from Lean Six sigma and Quality by Design. Our team of experts guarantees a multidisciplinary approach for any issue in the development and production of biopharmaceuticals that you might encounter.
- Cell line development
- Further up- and downstream process development
- Definition of analytical requirements
- Upscaling and improvement of manufacturing processes
- Technology transfer
- Single-use / disposable technologies
- Continuous chromatography and simulated moving bed