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


Biopharmaceutical cGMP Manufacturing Consulting Services

BioPharm Process Associates
Our firm delivers strategic biopharmaceutical cGMP manufacturing consulting services for biotherapeutics, vaccines and novel drug-delivery products produced with robust manufacturing bioprocesses at production sites worldwide.

We provide strategic guidance and essential industrial expertise for the bioprocess development, scale-up, design, manufacture, quality assurance and validation of your biopharmaceutical products. We identify and analyze potential partnerships, perform due diligence, evaluate bioprocess manufacturing alternatives and provide quantitative models of your biopharmaceutical manufacturing operations. In addition, we work closely with clients to achieve bioprocess manufacturing operational excellence and optimization of the biopharmaceutical manufacturing process, production planning and materials management systems. We have significant expertise with all of the bioprocess unit operations, including mammalian cell culture, bacterial fermentation, purification and final drug product processing.

We work closely with company management—and provide the critical skills necessary—to develop strategies that minimize the time to your successful FDA filings, thereby getting your biopharmaceutical products into the commercial marketplace quicker. Much of our work is strategic in nature, providing input on the most cost-effective biopharmaceutical and bioprocess development, definition of transferable manufacturing bioprocesses, identification of manufacturing alternatives, efficient production planning and finally integration of all of the necessary cGMP compliance components and quality assurance support systems. We specialize in both biopharmaceutical manufacturing optimization and organizational excellence, assisting our clients to implement the best technology and involve the best people to achieve world-class biopharmaceutical manufacturing operational results.

Biopharmaceutical cGMP Manufacturing Consulting Services

We provide the following consulting services:

  • Biopharmaceutical Manufacturing Strategy
  • Outsource/Partner Manufacturing
  • Design/Build Manufacturing Facilities
  • Bioprocess Development, Scale-up and Technology Transfer
  • Quality/Regulatory
  • Due Diligence and Technology Assessment

BioPharm Process Associates
(803)-548-9979 Telephone

5111 Telegraph Avenue, #116
Oakland, CA 94609

7121 Topsail Circle
Tega Cay, SC 29708

bioprocess scale-up