Find and compare companies providing Drug Substance (CDMO/CRO) services for:
Cell and gene therapy (DS)
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CDMO-CRO
Pioneering in advanced delivery technologies and development solutions.
Extensive global network ensuring supply chain resilience.
Tailored services across biologics, gene therapies, and pharmaceuticals.
All certificates
Replies slower than most
CDMO-CRO
Plants in:
Established in: 2002
Production scale:
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
CDMO-CRO
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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Drug Substance (CDMO/CRO)
Drug Substance CDMOs and CROs provide end-to-end solutions for pharmaceutical companies developing and manufacturing active pharmaceutical ingredients (APIs). These organizations offer critical support in R&D, process development, scale-up, and GMP manufacturing, enabling pharma and biotech companies to accelerate time-to-market while ensuring compliance with global regulatory standards.
Cell and gene therapy (DS)
Cell and gene therapy outsourcing focuses on producing advanced therapy drug substance such as viral vectors, plasmid DNA, or cell-based materials.
A pharmaceutical CDMO manages process development, GMP manufacturing, and specialized analytical testing for these modalities.
Typical steps include plasmid production, vector manufacturing, purification, and release testing.
Key constraints often involve biosafety controls, chain-of-identity, and cold chain logistics.
Practical answers for buyers sourcing CDMO services for cell and gene therapy drug substance manufacturing.
A cell and gene therapy CDMO produces advanced therapy drug substance such as viral vectors, plasmid DNA, or cell-based materials.
Services include process development, GMP manufacturing, and analytical testing specific to advanced modalities.
Include modality type, vector or cell process details, target scale, and required release tests.
Add storage requirements, chain-of-custody needs, and target markets.
Many do, supporting AAV, lentiviral, or adenoviral vectors.
Confirm platform experience, biosafety controls, and scale capability.
Typical steps include plasmid production, upstream vector production, purification, and fill of bulk drug substance.
Process steps vary by vector type and production platform.
CDMOs use tracking systems, barcoding, and controlled workflows to maintain chain-of-identity.
Ask about documentation, segregation, and audit trails.
Scales range from small clinical batches to larger commercial runs, often in modular or single-use systems.
Provide demand forecasts to align capacity planning.
Confirm GMP inspection history, biosafety controls, and validated release testing.
Ensure the facility meets regulatory expectations for advanced therapy products.
Critical analytics include potency assays, vector genome quantification, purity, and safety testing.
Confirm whether assays are in-house or outsourced.
Some CDMOs provide cryopreservation and cold chain logistics support.
Confirm temperature ranges, storage capacity, and transport controls.
Pitfalls include inadequate analytics, unclear chain-of-custody plans, and late changes to process parameters.
Early alignment on release criteria reduces delays.
Yes, many CDMOs support tech transfer with comparability studies and process documentation.
Provide detailed process parameters and critical quality attributes.
Timelines depend on vector platform maturity and assay readiness.
Early-stage programs often require additional development cycles to stabilize yields.
Most provide documentation for CMC sections, batch records, and release data.
Confirm the level of regulatory writing support needed.
Filter by region, modality, and services, then confirm platform experience and analytical capabilities.
Shortlist partners with proven GMP track records for your therapy type.
What is cell and gene therapy outsourcing (CDMO)?
When to choose a CDMO for cell and gene therapy
Common buyer requirements
Cell and gene therapy CDMO services FAQ
What does a cell and gene therapy CDMO do for drug substance?
What should I include in an RFQ for cell and gene therapy CDMO services?
Do CDMOs support viral vector manufacturing?
What are common steps in gene therapy drug substance manufacturing?
How do cell therapy CDMOs handle chain-of-identity?
What scale ranges are typical for cell and gene therapy CDMO manufacturing?
How do I evaluate GMP readiness for advanced therapy drug substance?
What analytics are critical for cell and gene therapy CDMO services?
Do cell and gene therapy CDMOs offer cryopreservation?
What are common pitfalls in cell and gene therapy outsourcing?
Can a CDMO support tech transfer for cell and gene therapy?
How long does advanced therapy process development take?
Do cell and gene therapy CDMOs support regulatory documentation?
How do I shortlist cell and gene therapy CDMO companies in this directory?
