Your Trusted Partner for Cell Therapy CDMO Excellence

As a collaborative, end-to-end cell therapy CDMO, we excel in managing all aspects of your product development lifecycle and associated supply chain, facilitating a seamless and successful journey from Good Manufacturing Practices (GMP) to market. This depth of knowledge allows us to ensure the safety, quality, and efficacy of developed products, while meeting the highest regulatory standards and maintaining efficient production timelines. Additionally, we offer commercial production of cell therapies for both US and European markets.

With a wealth of expertise across various technology platforms, we provide a comprehensive data driven, risk-based, and phase-approach control strategy utilizing a Quality Management System (QMS) that meets all cell therapy GMP manufacturing guidelines for facilities, procedures, and systems. This approach allows us to integrate commercial readiness early in the product development lifecycle and reduce common late phase Chemistry, Manufacturing, and Control (CMC) challenges, which is critical for a successful product launch. Learn more about our cell therapy tech transfer to new production introduction.

Discover the benefits of our cell therapy CDMO capabilities

Our suite of cell and gene therapy solutions can support your drug therapy's entire lifecycle, delivering a streamlined continuum from R&D product creation for proof of concept, to plasmid, viral vector, and cell therapy manufacturing. Integrated biologics testing and full-scale CDMO capabilities ensure the highest manufacturing quality control and efficient logistics management.

Explore our cell and gene therapy CDMO solutions

Driving Innovation in Gene-edited, Cell Therapies

Our cell therapy contract development and manufacturing organization (CDMO) center of excellence in Memphis is approved to manufacture Vertex’s CASGEVY™ therapy after passing back-to-back audits from both the US Food and Drug Administration (FDA) and the Health Products Regulatory Authority (HPRA), on behalf of the European Medicines Agency (EMA).

Accelerate Your Cell Therapy Program

An experienced cell therapy CDMO, we offer manufacturing services for various autologous and allogeneic cell types and starting materials, including marrow-infiltrating lymphocytes (MILs), dendritic cells (DCs), natural killer (NK) cells, T-cells, CAR-T, bone marrow-derived mesenchymal stem cells (BMSCs), mesenchymal stem cells (MSCc), whole blood, apheresis, leukapheresis, tumor isolates, and stem cells.

In addition, we have experience handling TILs, tumors (resections/biopsies/lysate), and apheresis material, including mobilized, whole blood, and buffy coat.

The success of cell and gene therapy development and manufacturing heavily relies on both the quality and consistency of starting materials as well as a manufacturer’s ability to obtain them at the right time. At Charles River, we offer a reliable, integrated solution that provides uninterrupted GMP-compliant human cellular materials, plasmid DNA, and vectors to ensure control in the starting material profile, helping to streamline the development and manufacturing process of cell and gene therapies.

Our comprehensive cell therapy CDMO support includes:

  • Manufacturing Science and Technology (MSAT) team

    A team comprised of experts in process development, technology transfer, and manufacturing support, offers optimized and scalable cell therapy manufacturing processes to support high-quality, efficient, and cost-effective manufacturing.

  • Quality management systems (QMS)

    From early phase through commercial manufacturing our comprehensive QMS ensure therapies are safe, effective, and meet regulatory compliance standards.

  • Quality control/release testing

    We uphold the safety, purity, and potency of cell therapy products through comprehensive analytical testing, meeting regulatory compliance, and maintaining quality throughout development and manufacturing.

  • Regulatory support

    This team will help you navigate the complex landscape of cell therapy development, ensuring compliance with global regulations at every stage, from early-phase research, to commercial manufacturing.

  • Clinical operations and logistics

    Having access to shipping and distributing patient materials and therapies as well as regulatory compliance guidance and project management expertise for clinical trials is paramount. Seamlessly progress treatments through clinical development into commercial manufacturing.

  • Assay development

    We offer assay development services to support cell therapy product characterization and release testing. Develop and validate assays to facilitate the safety, purity, and potency of cell therapies with the help of our specialists.

  • Validation and qualification

    Our team of experts can support developing and executing validation and qualification plans, including process and equipment, facility, and software validation.

Supply Chain Solutions for Minimizing Vein-to-Vein Time

We understand the intricate nature of supply chain management in cell therapy manufacturing. As part of our comprehensive services, we specialize in managing supply chain integration to ensure a seamless flow of materials and information throughout the development of GMP manufacturing, and commercial production process.

Supply Chain Management
We excel in coordinating schedules and collaborations with apheresis centers and clinics to facilitate the timely and safe collection of patient samples, including the harvest, formulation, packaging, and cryopreservation of cells and cell therapies.

Temperature-Controlled Storage & Shipment
We prioritize cell therapy integrity by meticulously managing temperature-controlled storage and transportation requirements before, during, and after shipping to preserve quality and efficacy. This includes customs clearance.

Logistics and Distribution
Our logistical solutions including the final stage of thawing and administering the therapy to maximize therapeutic benefits. Located near the FedEx Super Hub, our Memphis facility minimizes transit times and ensures timely delivery of critical materials.

Regulatory Bodies and Facilitating Clinical Trials

We take pride in our role as a trusted partner in your Cell Therapy GMP manufacturing process. We not only support relationships with regulatory bodies and act as your advocate, we interface with additional Contract Manufacturing Organizations (CMOs) and regulatory agencies for global clinical trials and product roll-outs. We understand the importance of seamless coordination and liaise with patient collection facilities and your Contract Research Organizations (CROs). With our expertise and extensive network, we are here to ensure that your manufacturing runs smoothly and efficiently, from Phase 1 to commercialization, allowing you to focus on advancing your therapies and bringing your products to market.

CDMO Suite Configurations for Scalable Needs

Whether expanding your manufacturing capabilities, or transitioning from clinical to commercial-scale production, our CDMO suite configurations provide the necessary infrastructure, equipment, and expertise to facilitate scaling. We support you in growing your operations with three suite configurations tailored to meet your unique needs and requirements.

  • Validated ISO 7 Grade B production containment suites that are US FDA compliant and can be used for cell therapy production or viral transduction
  • Validated ISO 7 Grade B production suites that are both US FDA and EU Annex 1 compliant for cell culture
  • Validated ISO 7 Grade B production suites that are both US FDA and EU Annex 1 compliant for cell culture or viral transduction

Frequently Asked Questions (FAQs) About Cell Therapy Manufacturing

  • What are the steps in cell therapy manufacturing?
    1. Starting Material Acquisition: Donor cells (allogeneic therapy) or patient cells (autologous therapy) are collected and processed to obtain the initial cell population.
    2. Cell Isolation and Expansion: The desired cell population is isolated and expanded in culture to achieve sufficient cells for therapy.
    3. Genetic Modification (if applicable): Gene editing or transduction techniques may be employed to introduce therapeutic genes or modify cell characteristics.
    4. Cell Harvesting: The cells are harvested from the culture and processed to remove impurities and unwanted cell components.
    5. Formulation and Final Product Preparation: The cells are formulated into the final product, which may involve cryopreservation, formulation in a specific medium, or other processing steps.
    6. Quality Control Testing: The final product undergoes extensive testing to meet safety, identity, potency, and purity requirements.
    7. Release and Distribution: Once the final product passes quality control testing, it is released for clinical use. It is then distributed to the treatment site or patient.

    Throughout the process, regulatory compliance, quality management, and documentation are crucial in ensuring the cell therapy product's safety, efficacy, and traceability.