In January 2026, the FDA issued a landmark announcement introducing a “Flexible Approach” to Chemistry, Manufacturing, and Controls (CMC) for Cell and Gene Therapies (CGT). This shift is a direct response to the unique challenges of CAR-T manufacturing—where the “batch” is a living medicine derived from a single patient, and traditional 3-lot validation rules often fail. Now, the question has shifted from “How do we fit CAR-T into traditional GMP?” to “How do we leverage new FDA flexibilities to accelerate our BLA without compromising safety?”

This masterclass will dissect the January 11, 2026, FDA announcement on CMC flexibility. We will explore how to transition from manual, open-system processes to automated, closed-system manufacturing while satisfying the FDA’s “Product Lifecycle” approach to validation. You will learn how to design Process Performance Qualification (PPQ) protocols that the FDA will actually accept in 2026—including the end of the mandatory “3-batch” rule and the rise of concurrent release.

Topics to be Covered

1. The 2026 FDA “Flexible CMC” Breakdown

• Deep dive into the January 2026 policy: What “flexibility” actually means for clinical development vs. commercial specifications.
• The end of the “3-Batch Rule”: How to justify your number of PPQ lots based on process understanding rather than legacy templates.

2. Phase-Appropriate GMP Compliance

• Navigating 21 CFR Part 211 exemptions: What is expected (and what is not) before entering Phase 2 and Phase 3 trials.
• Setting “Permissive” vs. “Final” Release Specifications: How to manage product quality standards as your clinical data matures.

3. Managing Manufacturing Changes & Comparability

• Strategies for making “Minor Changes” (e.g., equipment updates or site transfers) without triggering burdensome comparability studies.
• When and how to use Predetermined Change Control Plans (PCCPs) in the context of cell therapy automation.

4. Decentralized & Point-of-Care (POC) Manufacturing

• Regulatory hurdles for “Bedside” manufacturing: Ensuring sterility, potency, and traceability when production is distributed across multiple clinical sites.
• The role of Closed-System Automation (e.g., CliniMACS Prodigy, Cocoon) in satisfying FDA requirements for environmental control.

5. Potency Assay Challenges & Solutions

• Defining “Potency” for a living drug: FDA expectations for matrix-based assays and surrogate markers when traditional methods fall short.

Why Should You Attend?

In the high-stakes world of CAR-T, a CMC delay is a patient-access failure. This webinar is designed to give you a competitive edge in 2026.

• Accelerate Approval Timelines: Learn how to utilize Concurrent Release of PPQ batches to provide life-saving therapies to patients while completing your validation protocols.
• Reduce Development Costs: Identify which “burdensome” studies can now be bypassed or postponed under the new FDA “Flexible Approach.”
• Mitigate Refusal to File (RTF) Risks: Understand the exact level of CMC detail required for a BLA submission in 2026 to avoid costly agency “holds.”
• Direct Access to Strategy: Move beyond the guidance text to understand the “Scientific Justification” logic that CBER reviewers are currently looking for.

Who Will Benefit?

This session is curated for professionals responsible for the CMC and Regulatory pillars of CGT:

• VPs & Directors of CMC: To architect the commercial manufacturing strategy.
• Regulatory Affairs Leads: To manage BLA submissions and FDA negotiations under the new 2026 framework.
• Quality Assurance (QA) Heads: To implement phase-appropriate GMP and navigate decentralized manufacturing audits.
• Heads of Technical Operations: To oversee the transition from manual to automated, closed-system production.
• Cell Therapy Process Engineers: To understand the regulatory boundaries of process optimization.