Examples of Services by Category

Biopharmaceutical Product Development Services

Examples of Services by Category

Product development planning and evaluation

  • Assess feasibility of development program and preparation of Phase I/II clinical materials
  • Develop Product Development Plan for candidate products

Assay development and product release testing

  • Develop and validate analytical methods for product characterization
  • Perform comparability studies, redevelop or improve existing assays

Process development and formulation

  • Carry out process development, characterization and production of biopharmaceutical products for use in preclinical and Phase I/II clinical studies
  • Generate master and working cell/viral banks
  • Develop GMP-suitable and scalable process
  • Conduct formulation optimization studies
  • Complete stability indicating assays throughout process development and pilot manufacture

GMP manufacturing

  • Prepare Master Production Records
  • Manufacture biopharmaceutical products in compliance with FDA cGMP regulations
  • Perform QC release testing and execute stability testing program

Regulatory CMC documentation support

  • Support interactions with FDA at pre-IND and IND stages
  • Provide the required documentation for IND submission (e.g., Chemistry, Manufacturing and Controls (CMC) Information; Master Files)
Content last reviewed on April 20, 2016