Transform Your Research-Scale Protocols into Scalable Manufacturing Processes
Because cell therapy development is a rapidly evolving, complex, and competitive field, you need a CDMO process development partner with extensive experience using the most cutting-edge technology while establishing commercial viability and regulatory compliance.
As a full-service CDMO with over 20 years of experience in cell and gene therapy development and manufacturing services, we have established optimized, scalable production processes that propel your candidate forward and ensure consistent quality of the final product.
With our tech agnostic capabilities, we can optimize all stages of your process development by leveraging a variety of platforms. Learn more about our Flex Platform solutions.
Cell Therapy Processes Includes
- Cell selection and enrichment
- Gene editing and viral transduction
- pDNA and vector production
- Cell culture and expansion
- Harvest, formulation, fill and finish, and cryopreservation
- Moving processes from manual and open to automated and closed-system cell therapy manufacturing
From Gap Assessments and feasibility activities to process characterization runs and “hold-time” studies, we ensure your cell therapy manufacturing development runs smoothly. As part of our full suite of CDMO services, we also integrate tech transfer, quality management systems (QMS), QC testing, and onsite analytical development for early to late phase through commercial.
Cell Therapy Process and Analytical Development
Join our Director of Analytical Development, Sarah Campion, MS, and Director of Process Development, Alex Sargent, PhD, as they guide you along the commercial cell therapy pathway starting with key considerations in development through to IND/CTA filing and lot release.
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As a leader in the cell therapy space, we leverage our state-of-the-art facility in Memphis, TN to navigate the regulatory landscape and ensure compliance with relevant guidelines and regulations so you can bring potentially life-saving therapies to patients in need.
AI and Machine Learning in Process Development
Discover how to optimize cell therapy production processes, reduce cost, and increase efficiency with AI and machine learning through real-world examples and case studies.
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“This is a milestone for Kytopen as many cell therapies are developed and manufactured by CDMOs and we are excited to present this data from such a prestigious CDMO as Charles River. We have a GMP-scale manufacturing platform that has already been evaluated for tech transfer and this study further highlights the ease of implementation to develop superior yields of final drug substance.”
Kevin Gutshall, Chief Commercial Officer at Kytopen
Confidently Advance Your Cell Therapy with a CDMO Process Development Partner
Get the expertise and power of a full-service CDMO combined with a team of dedicated experts who engage early in process development, tech transfer, and manufacturing support to prevent future production delays. We can help you:
Avoid Common Roadblocks and Bottlenecks
Our team of experts have extensive experience in cell therapy process development. They can provide you with valuable insight and guidance for the development and optimization of the manufacturing process, as well as the design and implementation of quality control measures.
Get to Market Faster With Accelerated Development Timelines
We adapt and customize our standardized workflows and protocols to your needs. This helps us reduce development time with optimized processes, ultimately getting your product to market faster
Reduce Costs
With access to our specialized equipment, CDMO facilities, and resources, you can reduce the need for capital investment in expensive infrastructure and equipment and ensure your cell therapy is manufactured efficiently and cost-effectively.
Mitigate Risks
By outsourcing cell therapy process development, you reduce the risk of unexpected delays or failures in the development process. Our established quality systems and regulatory support help ensure your final product meets regulatory requirements and is safe and effective for patients.
Rapid, Seamless Transition to GMP Manufacturing
Streamline your supply chain, save time and money with a single partner for cell therapy process development and manufacturing. Our team can accelerate the development of your cell therapy, negating the need for bridging and validation studies, maintaining quality.
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Frequently Asked Questions (FAQs) About Cell Therapy Process Development
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What are the steps in cell therapy manufacturing process development?
Cell therapy process development can be broken down into three stages. First, we conduct a process assessment and gap analysis to define your development plan. Next, we de-risk the process through optimization, analytical assay development, and qualification. Finally, we confirm the process robustness and flow before transferring to GMP.
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Is investing in cell therapy process development services appropriate for a small biotech?
Because small biotechs have limited resources and infrastructure, they are most in need of cost-effective solutions. Small biotechs can benefit from the personnel, expertise, and equipment that come with working with a CDMO. Our cell therapy process development solutions allow you to progress your cell therapy development at a high level, without investing in infrastructure, investing in in-house expertise, or risking technical issues common of less experienced process development scientists.
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Is investing in cell therapy process development services appropriate for mid-sized biotech organizations?
Mid-sized biotechs tackle more complex projects, face more stringent regulatory requirements, and are under greater pressure to meet deadlines. Our cell therapy process development services can address all these challenges. Our decades of experience allow us to avoid common problems, accelerate timelines, and satisfy regulatory guidelines.
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What parts of the manufacturing supply chain can Charles River Labs help with?
Because we are a fully integrated and experienced cell and gene therapy CDMO partner, we can manage your entire process. Our capabilities include but are not limited to:
- Process and analytical development
- GMP analysis for reagent qualification and drug substance (DS) testing
- Manufacturing, Science & Technologies (MSAT) functions to ensure smooth transfer to GMP
- Autologous / allogeneic / gene-modified cell therapy manufacturing and Quality Control (QC) release testing for early to late-phase and commercial production
- Plasmid and viral vector products and services
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