Facility Features

• Secure spaces: receiving/holding material and QA records, and product storage
• Lab area for process development (PD)
• 1 clean room for BSL-2 GMP cell culture
• 1 clean room for BSL-2 GMP bio-mfg
• QC lab for environmental assays
• HVAC for single-pass, HEPA-filtered airflow
• Conference rooms and offices for client consulting
• Generator backup power
• Existing, lowest cost, expansion path for additional facilities

Services

• Consulting with clients for IND applications
• PD and scale-up services for pre- and post-IND applications
• Process optimization
• Master cell line development and storage
• Ph-1/2/3 BSL-2 biologics manufacturing
• Consulting with clients for NDA applications
• Technology transfer to client post
• scale-up
• Graduation to commercial production
• Pre-arranged facility expansion path (real estate, construction, operation)
• Highly trained staff