Expertise and Capabilities

scientist looking in microscope

Process Development for Manufacturing

  • Cell line development
  • Small- to pilot-scale fermentation and cell culture
  • Protein/virus isolation and purification
  • Formulation/lyophilization
preclinical and CGMP manufacturing

Preclinical and CGMP Manufacturing

  • CGMP-qualified cell banking
  • Mammalian cell culture (40–1000 L)
  • Fermentation/bioreactors (100–500 L)
  • Purification
  • Fill/finish/lyophilization
  • Virus production
female scientist

Process Analytics/Quality Control

  • Protein characterization
  • Assay development
  • Product release and stability testing
  • Mass spectrometry
  • Bioactivity and potency testing
  • Physio-chemical analysis
  • Process Analytical Technology (PAT)
book cover

Quality Assurance Oversight/Regulatory Affairs

  • CGMP compliance
  • Document review and product release
  • FDA and international regulatory submissions and support
  • Cross reference to BDP’s facility master file at FDA
glass tubes

Technology Transfer

  • Transfer of technology to companies for commercial production
  • Provide development and manufacturing methods, specifications, and regulatory documentation