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