Program Objective

The objective of this training program is to equip the learner with comprehensive, end-to-end knowledge of the manufacturing, quality control, regulatory compliance, and supply chain management of Chimeric Antigen Receptor T-cell (CAR-T) therapies. Upon completion, the learner will be able to independently apply global current Good Manufacturing Practice (cGMP) principles to autologous cell therapy products, design a contamination control strategy, define critical quality attributes, execute comparability studies following manufacturing changes, and manage post-marketing safety requirements across major regulatory jurisdictions (FDA, EMA, and ICH). The learner will also understand the scientific rationale behind each manufacturing step and the regulatory expectations for documentation, validation, and quality systems.

Program Scope

This program covers the entire vein-to-vein lifecycle of a CAR-T product, from the moment a patient is identified for treatment through the infusion of the final product and long-term follow-up. The scope includes:

• Regulatory frameworks including 21 CFR Parts 210, 211, 600, and 1271; EU EudraLex Volume 4 ATMP Guideline; and ICH guidelines Q8, Q9, Q10, Q5A, Q5B, Q5C, Q5D, and Q5E.
• Donor eligibility, leukapheresis collection, transport, and starting material controls.
• Viral vector manufacturing systems (lentiviral and gammaretroviral), including cell banks, upstream and downstream processing, and vector release testing.
• CAR-T cell manufacturing operations: thawing, enrichment, activation, transduction, expansion, harvest, formulation, fill, and cryopreservation.
• Analytical methods for identity, purity, potency, safety, stability, and adventitious agent testing.
• Facility design, cleanroom classification, HVAC systems, aseptic processing, and contamination control strategy.
• Process validation, change management, comparability studies, and technology transfer.
• Chain of identity, chain of custody, logistics, cryo-shipping, and cold chain management.
• Post-marketing safety, adverse event reporting, long-term follow-up, and risk management plans.

Target Audience

• Bioprocess and manufacturing associates working in cell therapy GMP facilities.
• Quality assurance and quality control professionals in biologics and ATMPs.
• Regulatory affairs specialists focusing on gene therapy products.
• Process development scientists and engineers.
• Clinical research associates monitoring cell therapy trials.
• Academic researchers transitioning to industry GMP roles.
• Supply chain and logistics managers handling cryogenic materials.
• Facilities and engineering personnel designing or operating cleanrooms for cell therapy.

Certification

Learners who successfully complete the program will receive a dated, traceable certificate that provides verifiable proof of their achievement for professional records.