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As cell, gene, and tissue-based therapies continue to redefine the frontiers of medicine, specialized ATMP CDMO companies have become essential partners in bringing these complex treatments to life. Advanced therapy medicinal products (ATMPs), including CAR-T cells, stem cell therapies, and gene-modified treatments, demand state-of-the-art manufacturing, rigorous compliance, and customized development approaches.
Whether you´re a biotech startup developing a first-in-class gene therapy or a pharma company scaling a tissue-engineered product, working with a trusted provider of advanced therapies contract manufacturing ensures your innovation moves smoothly from concept to clinic.
Not all CDMOs are equipped for advanced therapies. Here’s what to consider when selecting an ATMP CDMO:
Regulatory readiness: Proven experience with GMP requirements for ATMPs, including ATMP-specific guidelines under EMA and FDA
Specialized facilities: Cleanrooms for aseptic processing, viral vector suites, and segregated environments for autologous vs. allogeneic therapies
Scalability: Capacity to support your transition from preclinical batches to commercial manufacturing
QC and analytics: Advanced characterization tools for potency, purity, and safety of cell- and gene-based therapies
Tech transfer expertise: Seamless integration from academic, R&D, or early-phase platforms into GMP operations
Choosing the right partner early can prevent costly delays and compliance risks down the road.
Top advanced therapies contract manufacturing providers offer end-to-end support tailored to the needs of ATMPs, including:
Process development for viral vectors, stem cells, and genetically modified cells
GMP manufacturing for Phase I through commercial scale
Viral vector production (lentivirus, AAV, adenovirus, retrovirus)
Cell therapy services, including expansion, transduction, and cryopreservation
Fill & finish services under aseptic conditions
Analytical method development and validation for potency and identity testing
Cold chain logistics and controlled distribution
These services are critical for ATMPs where the product is often living, highly sensitive, and patient-specific.
Collaborating with experienced ATMP CDMO companies brings major advantages:
Reduced risk: ATMP-experienced CDMOs anticipate complex regulatory and scientific hurdles
Faster timelines: Integrated development and GMP readiness speed up IND/IMPD submissions
Tailored infrastructure: Facilities and processes are purpose-built for high-complexity therapies
Compliance assurance: These CDMOs have passed rigorous inspections specific to advanced therapies
Focus on innovation: Your internal teams can concentrate on R&D while the CDMO handles scale-up and manufacturing
The right Advanced Therapies CDMO doesn´t just produce your therapy — they become a core part of your development strategy.
Some of the leading ATMP CDMO companies in the global market include:
VIVEbiotech: Leading GMP-certified CDMO exclusively dedicated to the production of lentiviral vectors. [See CDMO profile]
Histocell: ATMP CDMO that develops and manufactures cell therapies from iPSCs, MSCs, secretomes, exosomes and other type of cells, as well medical devices and dermocosmetics. [See CDMO profile]
These companies are equipped to meet the strict demands of ATMP development while supporting rapid growth and innovation.
At MAI CDMO, we help you navigate the complex world of ATMP CDMO companies. Whether you need viral vector development, clinical cell therapy manufacturing, or support scaling a commercial gene therapy, we connect you with the most qualified advanced therapies contract manufacturing experts worldwide.
Ready to accelerate your ATMP development? Contact us today to find a CDMO that matches your therapy, timeline, and regulatory strategy.
If you have any questions or suggestions, click here. We will be happy to assist you.