Find and compare companies providing Drug Product (CMO) services for:
Cell and gene therapy (DP)
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Established in: 2002
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large
Specialized in biologics CDMO services with a focus on monoclonal antibodies.
Advanced facilities for clinical and commercial-scale manufacturing.
Strong commitment to quality and regulatory compliance.
All certificates
Replies slower than most
Expertise in cell therapy development and manufacturing.
Tailored solutions for autologous and allogeneic cell therapies.
Cutting-edge technology for scalable and efficient cell therapy production.
All certificates
Replies slower than most
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Find a list of providers specializing in CMOs/CDMOs Services for Cell and gene therapy (DP). Navigate through our extensive selection to identify the supplier that aligns with your specific needs.
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Drug Product (CMO)
Drug Product CMOs (contract pharmaceutical manufacturing) specialize in formulating, manufacturing, and packaging finished dosage forms such as tablets, capsules, injectables, and liquids. These organizations enable pharmaceutical companies to bring safe, effective, and compliant medicines to market by offering GMP-certified production capabilities, scalability, and regulatory support.
Cell and gene therapy (DP)
Cell and gene therapy outsourcing is partnering with a Contract Manufacturing Organization to manufacture advanced
therapy drug products. Typical steps include formulation, aseptic filling, cryopreservation, labeling, and controlled shipping.
Key constraints include chain of identity, small batch workflows, closed processing systems, and strict cold chain requirements. Advanced
therapy CMOs coordinate traceability and scheduling to protect patient-specific materials.
Use this guide to evaluate advanced therapy contract manufacturing services and avoid traceability gaps.
Answers to common questions about advanced therapy drug product manufacturing and cryopreservation.
Cell and gene therapy CMOs manufacture advanced therapy drug products, including autologous and allogeneic cell therapies and viral vector products. Services include aseptic processing, fill finish, and cryopreservation. Cell therapy contract manufacturing for drug product focuses on final formulation, aseptic filling, and cryogenic storage. Chain of identity and chain of custody controls are critical. Some CMOs support viral vector fill finish into vials or syringes with cold chain handling. Confirm biosafety level and containment requirements. Formats include cryovials, bags, and syringes depending on therapy type. Container selection impacts stability and administration. CMOs use controlled-rate freezing, cryogenic storage, and continuous temperature monitoring. Confirm temperature ranges and shipping logistics. Yes. Closed systems reduce contamination risk and support sterility. Ask about closed processing and single-use technologies. Batch sizes are often small and patient-specific for autologous therapies. Provide your workflow details to confirm scheduling and capacity. Many provide labeling, kit assembly, and serialization aligned to chain of identity. Confirm packaging and labeling workflows early. Pitfalls include cold chain gaps, chain of identity errors, and limited slot availability. Early planning and clear documentation reduce risk. Compare aseptic processing, cryopreservation capability, quality systems, and regulatory experience. Use this directory to shortlist advanced therapy CMOs. Advanced therapy outsourcing is a subset of finished dosage form manufacturing focused on cell and gene therapy drug products. Requirements are more specialized due to living materials. Yes. Provide process descriptions, critical quality attributes, and chain of identity requirements to support transfer and validation. Expect requirements for sterility, traceability, and donor or patient documentation. Confirm experience with FDA and EMA advanced therapy guidelines. Include therapy type, container format, cold chain needs, batch size, and target markets. Clear inputs help CMOs confirm facility fit and scheduling.What is cell and gene therapy outsourcing (CMO)?
When to choose a CMO for cell and gene therapy
Common buyer requirements
Drug Product buyer guide (CMO)
How to choose the right Contract Manufacturing Organization for cell and gene therapy
RFQ template: what to include for cell and gene therapy
Common pitfalls in cell and gene therapy outsourcing
Validation and regulatory notes for cell and gene therapy
Cell and Gene Therapy CMO services FAQ
What does a cell and gene therapy CMO manufacture?
What is cell therapy contract manufacturing for drug product?
Do CMOs support viral vector fill finish?
What are common container formats for cell and gene therapy drug product?
How do CMOs manage cryopreservation and cold chain?
Are closed systems important for advanced therapy manufacturing?
What batch sizes are typical for cell and gene therapy CMOs?
Do advanced therapy CMOs provide pharmaceutical packaging services?
What are common pitfalls in cell and gene therapy outsourcing?
How do I compare pharmaceutical contract manufacturing organizations for cell therapy?
Is finished dosage form manufacturing the same as advanced therapy outsourcing?
Can a pharma CMO services team support tech transfer for advanced therapies?
What regulatory expectations are common for cell and gene therapy CMOs?
What should I include in a cell and gene therapy RFQ?
