Records Management

PRODUCTS

  • Standalone, turnkey, process ready cGMP modular cleanrooms

    Germfree cGMP modular cleanrooms are a platform solution that unlock standalone manufacturing capacity for a variety of applications. Serving processes from cell therapy to sterile fill-finish manufacturing cGMP modular facilities offer unmatched finishes, layout flexibility, controls, timeline assurance, and cost benefits for the biopharmaceutical industry. This is why Germfree has been chosen by 12 of the top 20 biopharmaceutical companies as their modular cleanroom providers.

    Modular cleanrooms highlights: Biopharma, International building codes, IBC, NFPA, ISO. BSL-2 BMBL, FDA, EMA, cGMP compliant

    Applications: Aseptic Filling, Cell Therapy, Gene Therapy, Viral Vector, Plasmids

  • Scientific knowledge to strategize viable and efficient drug and device development pathways to achieve successful outcomes.

  • Controlled by software designed to meet 21 CFR Part 11 regulatory standards, Prometheus Panta C facilitates data integrity through distinct user access groups, while Active Directory integration provides centralized user authentication. Features such as electronic signatures, electronic records, and comprehensive audit trails further strengthen regulatory alignment.

  • Review how a comprehensive cGMP manufacturing facility is poised to support the development and manufacture of your mammalian cell program.

  • Find what you need to move your Alzheimer’s research forward faster, with antibodies to 95% of core AD genes validated in imaging applications with human samples.

WHITE PAPERS AND CASE STUDIES

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