Driving Your Autologous Cell Therapy Manufacturing Process Forward

When it comes to autologous cell therapy, we have processes in place with leading platforms in order to expedite your drug production timeline. Whether we are working with T cells, tumor-infiltrating lymphocytes (TILs), hematopoietic stem cells (HSCs), or dendritic cells, we are able to shorten timelines, reduce production costs, and help you safely and effectively get your drug product to patients.

As part of our global network of facilities, we offer in-house assay development and comprehensive analytical testing to ensure safety, purity, and potency of your cell therapy drug product. Learn more about our analytical development services.

With our Manufacturing Science and Technology (MSAT) team integration, we start with the end in mind, giving you assurance your drug product and tech transfer will be seamless and GMP ready. Our autologous cell therapy manufacturing processes are tailored to your drug product needs, including options for closed and automated systems. , As with all of our cell therapy manufacturing, we optimize processes and run feasibility studies from early phase through late phase to reduce risk and speed time to clinic. Check out our process development services.

Additionally, our automated formulation and fill finish capabilities ensure that your drug product maintains quality and consistency.

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"We commend the work by both teams in demonstrating the broad applicability of Finia for both autologous and allogeneic CGT manufacturing. Charles River is known as a leader in the field for contract CGT services, and we're thrilled to see them demonstrate their expertise using the Finia platform."

Stuart Gibb, Ph.D., Head of Scientific Strategy for Cell and Gene Therapies, Terumo BCT

Achieving Consistency in Fill and Finish for Autologous Therapies
Find out how you can achieve consistency and reduce risks to ensure scale-out strategies for multiple bag requirements and post-thaw viability of T-cell therapies in a closed environment.
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Reduce Vein-to-Vein Time for Autologous Cell Therapy

Autologous cell therapy development presents unique challenges due to the variable starting materials that add complexity to the manufacturing cycle. The primary hurdle is the limited collection-to-injection time from sample acquisition to treatment administration. To streamline the autologous cell therapy supply chain management and facilitate in-house testing for rapid release and prompt distribution, we offer:

Convenient GMP site location: Our Memphis GMP manufacturing facility's proximity to the FedEx SuperHub and Memphis International Airport facilitates efficient domestic and international logistics and distribution to avoid critical delays.
Relationships with key CGT couriers: With our proven track record of managing shipments, we enable reliable delivery of patient samples and therapies with trusted couriers.
Expertise in cell selection, isolation, and expansion: We optimize processes to achieve the highest quality and yield of therapeutic cells, enabling you to deliver personalized and effective treatments.
Access to cutting-edge technologies: Our comprehensive portfolio of in-house technologies and testing capabilities enables end-to-end movement throughout the development process, resulting in optimized and cost-effective manufacturing of therapies.
Quality compliance and support: Our manufacturing and quality control expertise ensures that therapies are safe and effective and meet regulatory compliance standards.
Intermittent release: With our quality operations oversight, our team has experience with intermittent and conditional release with quick turnaround times.
Comprehensive services: By offering a wide range of services, we’re your full-service autologous cell therapy CDMO, simplifying the development process and complex third party supply chains.

Charles River CDMO scientists manufacturing cell and gene therapies using therapy technologies

Cell Therapy Technology Spotlight
Keep up with the latest tech for cell and gene-modified cell therapy manufacturing by exploring our resource page featuring webinars, technical briefs, posters, and more.
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Advancing Autologous Cell Therapy Manufacturing Through Innovative Technology Solutions

As an autologous cell therapy CDMO, we are continuously testing and adopting leading platforms to optimize and enhance our drug product development and manufacturing, including the examples below.

CliniMACS Prodigy^® Platform

The CliniMACS Prodigy platform from Miltenyi Biotec is an automated, closed system for CGT manufacturing. The system combines magnetic cell separation with cultivation and transduction in a single device, allowing for efficient and standardized processing of patient samples. We leverage this platform to reduce variability and optimize your manufacturing processes while maintaining the safety and efficacy of your therapy. Because of the modular design, we can employ customization to meet your specific manufacturing needs.
Xuri Cell Expansion System W25

The Xuri Cell Expansion System W25 from Cytiva is another closed, automated system for expanding and manufacturing cell therapies. It employs a perfusion-based process that allows for the continuous production of therapeutic cells, leading to higher yields and reduced production time compared to traditional batch processes. We utilize the Xuri system to provide customizable, scalable, and reliable manufacturing solutions.
G-Rex^®

The G-Rex^® from Wilson Wolf is a gas-permeable rapid expansion platform for immune cell production. It enables the growth of large numbers of cells while shortening production cycles and reducing labor inputs. We use this platform to automate scale-out, simplify cell production logistics, and develop naïve phenotype immune cells.

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Frequently Asked Questions (FAQs) About Autologous Cell Therapy Manufacturing

What is allogeneic vs. autologous manufacturing?

Allogeneic cell therapy manufacturing involves using cells from a donor source to create cell therapies that can be given to multiple patients. In contrast, autologous cell therapy manufacturing involves using a patient's own cells to develop personalized cell therapies for that individual. Allogeneic manufacturing has the potential for greater scalability and cost-effectiveness, while autologous manufacturing offers the advantage of customized treatment with a reduced risk of immune rejection.
How can the scalability of autologous cell therapy manufacturing be optimized to meet the demands of clinical and commercial production?

The scalability of autologous cell therapy manufacturing can be optimized by implementing automated manufacturing processes, increasing the use of closed systems, and adopting bioreactors for cell expansion. Charles River helps streamline cell therapy manufacturing by providing access to advanced technologies like Miltenyi Biotec's CliniMACS Prodigy platform and GE Healthcare's Xuri cell expansion system, allowing for efficient and scalable manufacturing of autologous therapies.
Our expertise in cell selection, isolation, and expansion ensures the highest quality and yield of therapeutic cells, while our strategic GMP site location in Memphis next to the FedEx Super Hub further streamlines the autologous cell therapy supply chain, ensuring the timely international delivery of patient samples and therapies.