Choose the GMP-compliant cellular starting material that best meets your needs
Our GMP-compliant portfolio of products consists of fresh and cryopreserved GMP leukopaks and fresh GMP bone marrow aspirate. Our GMP-compliant cellular starting material stands unparalleled in the market, exhibiting exceptional quality and reliability that meets and exceeds the GMP requirements of our clients.
GMP Bone Marrow
Available in fresh format, our GMP bone marrow aspirate is subject to extensive quality review and supporting documentation to ensure GMP compliance.
GMP Leukopaks
GMP leukopaks are available in fresh and cryopreserved formats with both standard and customizable options for clients needing cellular starting material. We also offer Research Use Only (RUO) leukopaks.
GMP PBMCs
Fresh and cryopreserved GMP PBMCs offer an efficient solution for obtaining high-quality mononuclear cells from leukapheresis material without the need for labor-intensive isolation from leukapheresis products.
Defining GMP-compliant Cellular Starting Material
Cell and gene therapy starting material designations are based on the required quality assurance documentation for each product. We have a quality system for our GMP-compliant products that follows current GMP guidelines and builds on the high standards already employed with our research use only products.
-
Our Quality System for GMP-compliant Products Encompasses:
- Qualification of donors
- Qualification of vendors, equipment, and materials
- Equipment and calibration maintenance program
- Development, validation, and maintenance of procedures
- Comprehensive staff training and qualification
- Controlled documents and records management
- Management of deviations and corrective and preventive actions (CAPAs)
- Monitoring quality indicators for continual process improvement
- Temperature and environmental monitoring program
- Formal customer complaint process
- Internal assessment program and routine external inspections
- Entire process conducted under a Master Batch Record (MBR)
Characterizing Donor-Derived Cellular Starting Material for Advanced Therapies
This webinar highlights how sourcing cellular starting material and a highly characterized donor network can help maintain regulatory compliance while advancing your cell or gene therapy program. Watch On Demand
Quality and Regulatory Standards
We comply with procedures governing the sourcing, handling, processing, storage, preservation, packaging, and distribution of products. We are AABB accredited, meet CLIA requirements for quality control testing, and comply with California production laws for biologics and tissue banking. This ensures an appropriate quality management system and controlled collection processes are in place. Our GMP-compliant facility is routinely audited by the FDA, State of California, and AABB.
-
Expertise and Resources to Meet Regulatory Requirements
- Our GMP-compliant cellular starting materials are manufactured under rigorous quality standards in accordance with FDA (21 CFR 210, 211, 606, 1271) and other global regulatory guidelines, including EMA and PMDA.
- Our FDA-registered donor center (blood and HCT/P) operates to CGMP and CGTP standards and is fully aligned with international regulatory expectations.
- We follow IRB-approved protocols and maintain robust donor center consent processes designed to support regulatory submissions and global program scalability.
- A dedicated team of regulatory experts, scientific advisors, and quality specialists ensures ongoing compliance and provides the insight needed to help keep your program on track.
- Our viral screening capabilities support foreign regulatory requirements, helping accelerate clinical development and streamline product approval pathways.
-
Accreditation and Licensure
- U.S. FDA (Food & Drug Administration) Blood and HCT/P Registrations
- State of California Biologics Production and Clinical Laboratory Licensure
- AABB (Association for the Advancement of Blood & Biotherapies) Accreditation
- CLIA (Clinical Laboratory Improvement Amendments) Certified
- CGMP – Meets regulatory requirements for producing GMP-compliant biologics
Superior Donor Management and Recruitment Expertise to Support Your GMP Project
With over 400,000 apheresis collections successfully completed, clients can trust our excellence in donor operations. Our clients have access to a diverse and well-characterized active, recallable, HLA-typed, and CMV-negative donor network. We have the resources to provide sufficient cellular starting material to satisfy process development and commercialization needs and provide backup donors for collections if necessary. Our donor center is FDA-registered, AABB-accredited, CLIA-certified, and state-licensed.
GMP-compliant cellular starting materials may include custom product and process validations (e.g. additional donor characterization, donor testing, SOPs, staff training and validation during manufacturing), as required per client product request.
-
Recallable Clinical Donor Pool
- Active, Recallable, HLA types and CMV-negative donor pool, we have the resources to provide the material needed for GMP projects, from process development to commercialization.
- Backup donors for collections are available, if necessary.
- Large, CMV-negative donor pool.
- Our recallable donors are ages 18 – 45 years old and have flow data for donor characterization.
-
Matched Donors & Recruitment Expertise
- Proactive outreach to recruit and match donors to specific project criteria.
- Quality-assured viral screening to meet foreign regulatory requirements (e.g. EMA and PMDA).
- Careful donor characterization as required based on client’s inclusion/exclusion criteria (e.g. gender, blood type, age, BMI, cell compositions).
- Donor management is key to meeting all pre-collection assessments and testing requirements.
-
We Build & Maintain Donor Relationships
- Dynamic and deep-rooted relationships with our donors are the foundation to support the cell therapy industry and ensure a healthy, diverse, and recallable donor pool.
- Our donor management team fosters relationships and cultivates trust to ensure a continued supply of high-quality starting materials
-
Steadfast Focus on Donor Safety
- Donor safety is ensured through comprehensive screening, physical exams and testing, in compliance with guidance from IRB, AABB, and the FDA.
Shipping Capabilities to Simplify Complex Logistics
Our products are shipped using standard shipping contractors. Each vendor is qualified through our Supplier Qualification Program (SQP), which includes the following:
-
Qualification of Shipment Companies
- On-site audit of their facility, quality management system, material control, shipping processes, and qualified shipping procedures
- On-site review of validation documentation for packaging solutions
-
Shipping Conditions
- Fresh (2 – 8 °C or 15 – 25 °C) validated containers
- Cryopreserved – LN2 Dry vapor Dewar (validated up to 10 days in transit)
A Long-Term Commitment to Our Client's Success
Our total quality management approach focuses on customer service, unparalleled donor care management and recruitment, proven reliability and quality, and market-leading cell sourcing capabilities, which means we support our clients every step of the way throughout their journey across the entire development continuum.
Why Choose Charles River Cell Solutions As Your GMP Starting Material Provider?
- Clients can depend on us to solve sourcing problems.
- We offer more options for donor characterization, testing, and product shipments.
- Access to a GMP-compliant portfolio of products with options that save you resources.
- Our internal team consists of industry-leading scientific experts, regulatory advisors, and a team dedicated to quality assurance.
- We have an active, recallable, and highly characterized clinical donor pool.
- Well-organized and coordinated donor management and recruitment expertise to ensure inclusion requirements are easily met.
- CGMP and CGTP processes and equipment reduce variability to ensure quality and consistency while minimizing risk.
- Our proven track record and comprehensive solutions support client's starting material and manufacturing needs from the clinic to commercialization.
Optimize Cell Therapy Manufacturing Efficiency with Cryopreserved Cells
View this webinar to learn how purified and cryopreserved cell populations streamline logistics, reduce variability, and enhance transduction efficiency in CAR-T production.
Watch on Demand