Process Development

• Research cell and virus banks generation and testing

• Upstream Process development activities using single-use technologies for suspension and adherent cell lines (small scale and scale-up for process verifications) and establishment of processes for harvest, lysis, clarification

• Downstream Process development activities using column and membrane chromatography, variety of bioprocess filtration platforms (tangential flow, hollow fiber, depth filtration)

• Development of aseptic process for product that cannot be sterile filtered

cGMP Manufacturing

• 6,000 square-foot upstream and 9,000 square-foot downstream manufacturing areas for the production of BSL2 biologics for clinical trials

• State-of-the-art GMP facilities with capabilities to cover various upstream and downstream production platforms for cell culture and virus manufacturing

• Quality Control and Quality Assurance practices and processes throughout the entire production process covering equipment validation, facility release, and approval of required documents to release of cGMP product

• Validated change-over and cleaning procedures between each project

Fill / Finish

• Grade A clean room for aseptic liquid filling of clinical trial materials for liquid
and lyophilized drug product
• Filling of vaccines, vectors, antibodies, recombinant protein therapies, and other biologics
• Automated fill line up to 7,000 vials, semi-automated fills
up to 2,000 vials and lyophilization up to 4,000 vials
• Inventory of standard 13mm container/closure stock for 2mL and 3mL vials
• Work with clients to develop custom configurations to
best meet product and storage requirements
• After filling, final product undergoes QC inspection, labeling
and storage at the appropriate temperature