Bioprocess Online Covers 2026 ISPE Annual Meeting & Expo Upcoming Session on a Quality Management System That Anticipates Cell and Gene Therapy (CGT) Challenges
23 September, 2026
As cell and gene therapies (CGT) continue to push the boundaries of personalized medicine, traditional quality management system (QMS) approaches are being tested by the unique challenges of early-stage development. These issues will be a key topic at the 2026 ISPE Annual Meeting & Expo, where Andrew Cieri, Executive Director of Quality within Regeneron’s Cell Medicines unit, will share lessons learned from integrating a Phase 1 CGT program following a corporate acquisition.
According to Cieri, building a quality system for an early-stage CGT (CGT) program differs significantly from implementing quality controls for traditional drug development. Clinical and manufacturing data are often limited, patient-specific starting materials introduce considerable variability, and manufacturing failures may directly impact patient treatment opportunities. These challenges become even more complex when a product changes ownership and must be integrated into an existing organization’s quality framework.
One of the article’s central themes is that quality systems for CGT products must be both risk-based and phase-appropriate. Rather than applying a fully commercial-grade quality system to a Phase 1 program or simply adopting the acquired company’s existing processes, Cieri advocates evaluating each quality element individually. The goal is to determine what controls are necessary at the current stage of development while ensuring patient safety, product quality, and regulatory compliance remain protected.
For Phase 1 CGT programs, Cieri argues that several quality elements are non-negotiable regardless of development stage. These include aseptic processing and contamination control, chain of identity and chain of custody from the first draw, traceability from donor to product to patient, data integrity, and good documentation practices. Because these therapies are often derived from a patient’s own cells and involve little margin for error, weaknesses in these areas can directly affect patient outcomes. As a result, these controls should remain rigorous from the earliest stages of development.
At the same time, not every process parameter requires rigid controls during early development. Cieri recommends using a severity-by-likelihood risk matrix to determine which quality attributes warrant strict oversight and which should remain flexible while knowledge about the process continues to evolve. Process risk assessments and simulated manufacturing runs can help identify the activities most likely to affect patient safety or product quality, allowing organizations to focus resources on the areas that matter most. This approach helps avoid overengineering controls before sufficient scientific understanding has been established.
The Regeneron acquisition case highlights the challenges organizations face when merging quality systems from different companies. In this instance, Regeneron’s Cell Medicines unit operated with a mature commercial-quality infrastructure, while the acquired therapies remained in Phase 1 development. Rather than automatically imposing one system over the other, the company evaluated procedures, training programs, computer systems, and quality requirements through a phase-appropriate lens. Patient safety and regulatory defensibility ultimately served as the deciding factors when quality system conflicts arose.
Beyond procedures and systems, Cieri emphasizes that cultural integration can be just as important as technical integration. Documentation practices, decision-making styles, and risk tolerance often differ significantly between organizations. Regeneron addressed these challenges through shared leadership principles, cross-functional training, floor-level quality presence during manufacturing activities, and structured pre- and post-run reviews. Documenting the rationale behind risk-based decisions not only supports regulatory compliance but also helps teams align around a common understanding of acceptable risk.
The article also explores what risk-based quality assurance looks like in day-to-day CGT operations. Because patient-specific starting materials can vary considerably, incoming material controls become a critical focus area. Historical data can be used to identify variability patterns and establish flexible acceptance criteria tailored to patient characteristics rather than relying solely on rigid specifications. At the same time, active quality oversight during manufacturing is essential, particularly because many CGT processes involve significant manual intervention. Continuous quality assurance presence, rapid deviation management, daily operational reviews, and operator requalification all contribute to maintaining product quality.
A particularly important challenge in cell and gene therapy manufacturing is balancing risk with the urgency of patient treatment. Since a failed batch may mean a patient loses access to a potentially life-saving therapy, organizations must carefully distinguish between necessary controls and unnecessary delays. Cieri notes that companies should be inflexible on true quality-critical elements such as aseptic processing and chain of identity, while remaining open to evidence-based approaches that accelerate treatment timelines.
One example involves sterility testing. Traditional compendial sterility tests can require approximately two weeks to complete, which may be incompatible with the treatment timelines of oncology patients. Regeneron has utilized rapid sterility, endotoxin, and mycoplasma testing methods to support risk-based release strategies that enable earlier product shipment while full confirmatory testing continues. Although this approach accepts a degree of additional risk compared to waiting for traditional testing completion, Cieri argues that delaying treatment may represent an even greater risk for certain patients. The strategy relies on documented risk assessments, predefined response plans, and ongoing monitoring to ensure patient safety is not compromised.
Looking back on the integration process, Cieri advises companies to avoid treating acquisitions as simple change-control exercises. Instead, organizations should establish dedicated transition plans that address quality, manufacturing, IT, documentation, and cultural integration separately. He also warns against automatically assuming that the larger or more mature quality system should prevail. Every quality element should be assessed according to the developmental stage of the therapy and the needs of the patient.
As discussions at the 2026 ISPE Annual Meeting & Expo will highlight, successful quality management in CGT requires a careful balance between flexibility and control. By focusing on patient impact, applying risk-based decision-making, and building quality systems that can evolve alongside respective therapies, organizations can create a QMS capable of supporting innovation while maintaining the high standards required for product quality and patient safety.
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