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