Microbiology and Infectious Diseases Resources

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)