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PRODUCTS

  • The importance of strategic process development (PD) as a program advances cannot be overstated. It is critical to increasing yields, achieving product quality expectations, and lowering the cost of goods while meeting clinical development milestones.

    The Center for Breakthrough Medicines (CBM) has a PD team with unrivaled experience building and optimizing processes for commercial cell and gene therapies.

  • Connect your entire operations across internal and external sites

    Product Lifecycle Data

    Consolidate data for each stage of a drug’s lifecycle in one place.

    • Expedite compliance by centralizing product lifecycle data for each stage
    • Shorten the time between one stage to the next
    • Streamline tech transfer and accelerate to commercial rollout

    Enterprise Recipe Management

    Optimize enterprise recipe management  across environments and sites.

    • Create and manage a core set of enterprise-wide templates
    • Get access to customizable resources for every stage
    • Easily assign your templates and resources to individual sites and teams

    External Manufacturing Collaboration

    Ditch email and calls for automated communications.

    • Grant direct view-only access and batch review options as needed
    • Provide customers with a self-service approach to their sponsored batches
    • Make real-time, data-driven decisions

    Tech Transfer

    Quickly and easily move all your master resources and data.

    • Securely store batch templates, procedures, materials and equipment classes
    • Easily share process knowledge and data through transferable global recipes
    • Shift a product ad-hoc from one team to another
  • 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

  • Ideal tool for characterizing nanoparticles

    The Corning Videodrop utilizes the principles of interferometry in conjunction with microscopy to sense, detect, characterize, and track single nanoparticles in real time. The operation of this bioproduction analytical device is seamless thanks to its intuitive software interface and efficient sample handling protocol.

  • Freeze-Pak™ STS (FP-STS) Storage and Transport Solution Bio-Containers are designed for ultra-low temperature frozen storage and transport applications.

WHITE PAPERS AND CASE STUDIES

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