Choosing the right cell therapy manufacturing partner isn’t just a box to check—it’s a crucial decision that can shape your project’s success. With high stakes, strict regulations, and tight timelines, how do you know which U.S. factory stands out from the rest? Selecting a top-tier supplier can mean faster development, uncompromising quality, and serious peace of mind. Curious which manufacturers rise above the noise? Dive in to discover the best options for your next breakthrough.

Related Video

FrontPage | NSF Engineering Research Center for Cell Manufacturing …

Product Details:
CMaT (Cell Manufacturing Technologies) develops engineered processes for the large-scale, lower-cost, reproducible, and high-quality manufacture of cell-based therapeutics for industry and clinical use. CMaT also offers training, research experience, and professional development programs in cell manufacturing.

Technical Parameters:
– Focus on large-scale, reproducible, and lower-cost manufacturing processes for
– Emphasis on high-quality, engineered, and standardized cell production processes
– Integration with academia-industry partnerships for manufacturing solutions and

Application Scenarios:
– Mass manufacturing of cell-based therapeutics for clinical treatments
– Industry adoption of engineered cell manufacturing processes for product
– Educational and research training for students, teachers, and postdoctoral

Pros:
– Reduces manufacturing costs and increases reproducibility for cell therapeutics
– Improves quality and scalability of cell-based products for broader clinical
– Collaborative network involving academic, industry, and policy groups for rapid
– Offers hands-on training and career development for students, teachers, and

Cons:
– Limited information on commercially available or market-ready products
– May require substantial infrastructure and expertise for implementation

AstraZeneca expands US manufacturing footprint to accelerate ambitions …

Product Details:
AstraZeneca is advancing next-generation cell therapy platforms, focusing mainly on T-cell therapies (CAR-T and TCR-T) for cancer. The new $300 million Rockville, MD facility will manufacture these therapies to support clinical trials and future commercial supply, initially targeting oncology with potential expansion into other disease areas. Lead assets include GPC3-targeted CAR-T (AZD5851), Claudin 18.2 CAR-T (AZD6422), STEAP2 CAR-T (AZD0754), and a pipeline of individualized and mutant-specific TCR-T therapies (NT-125, NT-175, NT-112).

Technical Parameters:
– Manufacturing facility designed for scalable cell therapy production, focusing
– Pipeline includes armoured autologous CAR-Ts (e.g., AZD5851 targeting GPC3 in
– TCR-T pipeline includes NT-125 (fully individualized), NT-175 (TP53 mutant

Application Scenarios:
– Treatment of various solid tumors, including hepatocellular carcinoma and
– Use in clinical and potential commercial settings for oncology indications with
– Empowering immune system T-cells to overcome the immune-suppressive tumor

Pros:
– State-of-the-art manufacturing facility with capacity for rapid scale-up and
– Highly innovative portfolio targeting both commonly mutated cancer genes and
– Pipeline includes potential for fully individualized T-cell therapies and
– Integration within Maryland’s strong life sciences ecosystem provides access to

Cons:
– Major assets are still in early-phase clinical development, so regulatory
– Initial focus is limited to clinical trial supply, with commercial-scale
– Success in development of cell therapies for solid tumors remains

cGMP cell therapy development and manufacturing services – Patheon

Product Details:
Patheon Pharma Services offers cGMP cell therapy development and manufacturing services as part of its advanced therapies portfolio, supporting biologics and cell therapy projects from early development through commercialization.

Technical Parameters:
– Compliance with current Good Manufacturing Practice (cGMP) standards for cell
– Integrated solutions for development, manufacturing, and clinical supply chain
– Flexibility to support both clinical and commercial-scale needs

Application Scenarios:
– Development and manufacturing of cell-based therapies for clinical trials or
– Advanced therapy medicinal product (ATMP) projects requiring regulatory-complian
– Support for pharmaceutical and biotech companies in scaling up novel cell

Pros:
– Fully integrated approach covering development, manufacturing, and supply chain
– Expertise in regulatory compliance and clinical trial support
– Flexible solutions tailored to different therapy scales and stages

Cons:
– Potentially limited information available on specific cell therapy platforms or
– May require further contact to clarify detailed technical capabilities or

Bayer Opens First Cell Therapy Manufacturing Facility

Product Details:
Bayer has opened its first cell therapy manufacturing facility to advance regenerative medicines on a global scale. The company also provides solutions in agriculture (crop science), pharmaceuticals, and consumer health.

Application Scenarios:
– Manufacturing of cell therapies for regenerative medicine
– Healthcare and therapeutic innovations
– Advancement of agricultural solutions for improved crop efficiency

Pros:
– Supports the global scale production of advanced regenerative medicines
– Demonstrates leadership in both healthcare and agriculture sectors
– Offers tailored agricultural solutions for efficient use of land, water, and

Cell Therapy Contract Manufacturing Services | SK pharmteco – CBM

Product Details:
Cell therapy contract manufacturing services (CDMO) offered at all scales and development phases. Expertise in both autologous (e.g., CAR-T) and allogeneic cell therapies, including critical component production such as plasmid DNA and viral vectors. Services include single-site manufacturing and world-class analytical testing within a Philadelphia, USA campus.

Technical Parameters:
– Single-site operation for manufacturing and analytical testing, reducing
– Expertise in autologous and allogeneic cell therapy manufacturing
– Capability for production of plasmid DNA and viral vectors
– Partner-in-Plant program allowing client collaboration during CGMP operations

Application Scenarios:
– Manufacture of adoptive cell therapies (e.g., CAR-T) for clinical use
– Production of cell therapies for the treatment of cancers, neurological
– Scale-up and development of new cell and gene therapy programs entering

Pros:
– End-to-end capabilities in a single site, offering seamless hand-off between
– Reduced vein-to-vein time for adoptive cell therapies, improving patient benefit
– Deep domain expertise with experience in bringing first-in-class cell therapies
– Flexible and transparent collaboration models, such as Partner-in-Plant

Cons:
– Cell therapy manufacturing is inherently complex and requires batch-specific,
– No specific technological limitations or bottlenecks are detailed, but general

Cell Therapy & Gene Engineering Facility | Moffitt

Cell therapy operations and manufacturing fact sheet

Cell Therapy Manufacturing | Thermo Fisher Scientific – US

Cell Therapy Manufacturing – MilliporeSigma

Product Details:
The company offers products and tools for cell therapy manufacturing, including the CryoSOfree™ DMSO-free Cryopreservation Medium and Mobius® 2D and 3D single-use assemblies and systems for sterile fluid management.

Technical Parameters:
– CryoSOfree™ is a DMSO-free cryopreservation medium.
– Mobius® assemblies are available in 2D and 3D single-use formats for sterile

Application Scenarios:
– Upstream and downstream cell therapy processing
– Sterile fluid management from media and buffer preparation to final fill
– Cryopreservation of cell therapies without DMSO

Pros:
– DMSO-free medium reduces toxicity for cell preservation.
– Single-use assemblies minimize risk of contamination and provide manufacturing
– Comprehensive solutions cover multiple manufacturing stages, reducing process

Cons:
– Reliance on single-use systems may generate more disposable waste.
– Potentially higher costs associated with specialized single-use or DMSO-free

Bayer’s Cell Therapy Manufacturing Facility, California, USA

Comparison Table

Frequently Asked Questions (FAQs)

How do I find reputable cell therapy manufacturing factories in the USA?
Start by researching online directories, industry associations, and attending relevant conferences. Networking in biotech forums and consulting with industry experts can also provide valuable recommendations. Always check for company credentials, experience, and reviews before reaching out.

What certifications should a cell therapy manufacturing facility have?
Look for facilities that are FDA-registered and compliant with cGMP (current Good Manufacturing Practices). Additional certifications like ISO 13485 (for medical devices) and specific quality control certifications can add to their credibility.

How can I evaluate a manufacturer’s experience with my specific cell therapy product?
Ask for case studies, references, and information on previous projects similar to your therapy. An experienced manufacturer should provide details about their process, success stories, and regulatory submissions related to your specific cell type or modality.

What should I consider when comparing manufacturing costs?
Compare quotes carefully, considering not just the per-batch price but also services included, minimum order quantities, setup fees, scalability options, and post-manufacturing support. Remember, the cheapest option may not always offer the best value or quality.

Is it possible to tour a cell therapy manufacturing facility before choosing a supplier?
Yes, most reputable manufacturers welcome facility tours as part of their transparency and quality assurance. Scheduling a visit allows you to assess their equipment, cleanliness, staff expertise, and overall operations firsthand. Always request a tour before making any long-term commitment.