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    CDMOHUB

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    © 2026 CDMOHUB. All rights reserved.

    CDMO Hub, Inc. Registered in Delaware, USA

    CDMOHUBCDMOHUB
    Find ExpertsBriefingsPricing
    CDMOHUB

    Connecting biotech and pharma teams with verified manufacturing partners worldwide.

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    • Find CDMOs
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    • Expert Matchmaking
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    © 2026 CDMOHUB. All rights reserved.

    CDMO Hub, Inc. Registered in Delaware, USA

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    1. Home
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    3. /Cell & Gene Therapy CDMOs
    Category

    Cell & Gene Therapy CDMOs

    Compare CDMOs with advanced therapy manufacturing capabilities for viral vectors, cell therapies, and gene therapies. Filter by vector type, scale, and regulatory experience.

    About Advanced Therapy Manufacturing

    Cell and gene therapy manufacturing is the most technically demanding segment in pharma outsourcing. Viral vector production (AAV, lentiviral, adenoviral) requires specialized biosafety facilities and purification platforms. CAR-T manufacturing adds patient-specific logistics for autologous therapies.

    Capacity is scarce. Global demand for AAV vector manufacturing exceeds supply by an estimated 3-5x. CDMOs with suspension-adapted production systems running at 200L+ scale are particularly sought after. For allogeneic cell therapies, look for CDMOs with experience scaling from research-grade to cGMP production.

    Regulatory complexity is higher than for conventional biologics. In the US, gene therapies follow the BLA pathway with additional Chemistry, Manufacturing, and Controls (CMC) requirements. The EU classifies these as ATMPs (Advanced Therapy Medicinal Products) with dedicated oversight from the EMA's CAT committee. Your CDMO needs direct experience with these filing pathways.

    No companies found in this category yet. Check back soon.

    Browse all CDMOs

    Frequently Asked Questions

    What makes cell therapy manufacturing different from other biologics?+
    Cell therapy manufacturing involves processing living cells as the final product, not as a production tool. Autologous therapies (like CAR-T) are made from each patient's own cells, creating unique supply chain and scheduling challenges. The manufacturing process must maintain cell viability, identity, and potency throughout. Cleanroom requirements are typically ISO 5/Class 100 for open processing steps.
    What regulatory requirements apply to gene therapy CDMOs?+
    Gene therapy CDMOs must comply with cGMP and biosafety requirements for handling viral vectors. In the US, FDA requires Investigational New Drug (IND) applications with detailed CMC sections covering vector production, purification, characterization, and potency testing. Facilities need Institutional Biosafety Committee (IBC) approval. The EU requires ATMP classification and additional quality dossiers for the EMA's Committee for Advanced Therapies.

    Related Categories

    Biologics CDMOsOncology CDMOsCDMOs in North AmericaCDMOs in EuropeFDA-Registered CDMOs

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    CDMOHUB

    Connecting biotech and pharma teams with verified manufacturing partners worldwide.

    Platform

    • Find CDMOs
    • Find Experts
    • CDMO Matchmaking
    • Expert Matchmaking
    • Modality Guides
    • Supplier Maps
    • Join as Partner

    Company

    • About Us
    • Contact

    Legal

    • Terms of Service
    • Privacy Policy

    © 2026 CDMOHUB. All rights reserved.

    CDMO Hub, Inc. Registered in Delaware, USA