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