Process Development, Scale-up and Technology Transfer Services
Our extensive process development experience will ensure that your process technology is translated into a robust, scalable, economic and validatable manufacturing process quickly. Whether for clinical or commercial production, we can help your organization:
- Plan bench-top process development for recombinant proteins, monoclonal antibodies and vaccines produced in bacterial fermentations, mammalian cell culture or eggs.
- Incorporate scalable unit operations into your process.
- Scale-up the production process to produce clinical supplies.
- Ensure your process meets all relevant regulatory requirements.
- Define and execute formulation development, in-process testing, bulk and final product testing and release.
- Coordinate technology transfer of a scaled-up cGMP manufacturing process.
- Develop and deliver on a defined project timeline.
BioPharm Process Associates