Records Management

PRODUCTS

  • What is included in Forge's DMF?

    DMFs come in all shapes and sizes, but Forge's DMF includes the following components:

    • Information on our critical raw materials, including our Ignition Cells™ and pEMBR™ adenovirus helper plasmid
    • An overview of our platform AAV manufacturing process
    • Process controls
    • Facility layout and engineering information
    • And more!
  • Getting a novel therapy through the clinical development process to approval is complicated. Unearth how to advance novel medical therapies from Phase I-III clinical development to market with confidence.

  • Navigating the technical challenges of mAbs production and scalability

    Monoclonal antibodies (mAbs) offer promising immunotherapy treatments, targeting antigens and diseases. Manufacturing these complex therapies presents challenges in scaling up, cost, and consistency. Germfree’s expertise in tailored cleanroom solutions addresses these obstacles, ensuring sterility and seamless equipment integration. By providing advanced facilities for both small-scale clinical trials and larger-scale production, Germfree contributes to the successful development and commercialization of mAbs, ultimately improving patient outcomes and transforming healthcare landscapes.

  • AGC Biologics’ quality organization provides a comprehensive suite of Quality Assurance (QA) and Quality Control (QC) services. At each of our manufacturing facilities, highly trained Quality Units maintain strict quality systems to support our cGMP manufacturing efforts and to ensure compliance with all regulatory requirements.

WHITE PAPERS AND CASE STUDIES

NEWS