BioPharm Process Associates biopharmaceutical manufacturing, bioprocess development and due diligence consulting
biopharmaceutical process development

scale-up and technology transfer services

Biopharmaceutical Process Development Services


process development for recombinant proteins, monoclonal antibodies and vaccines
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
info@biopharmprocess.com
(510)-985-0336 Telephone

 

 
 
technology transfer of a scaled-up cGMP manufacturing process