Latest Developments in Cell and Gene Therapy Manufacturing: Focus on Fill-Finish Capabilities

Cell and gene therapies (CGTs) continue to revolutionize treatment options for patients with chronic conditions and rare genetic disorders. As the industry expands, developers face significant challenges in scaling up production while maintaining product quality and safety. Recent insights from industry experts highlight the critical importance of fill-finish capabilities in CGT manufacturing.

Growing Investment and Development in CGT

The CGT sector has seen substantial growth, with investments increasing by over 20% annually since 2022. Currently, more than 4,400 CGT products are in development worldwide, underscoring the industry's rapid expansion and potential impact on patient care.

Critical Challenges in CGT Manufacturing

Despite the promising outlook, CGT developers must overcome various obstacles to successfully commercialize their products. Among these, maintaining consistent, high-quality fill-finish capabilities is often overlooked but crucial for successful scale-up.

Roberto Estrada, supervisor of fill-finish manufacturing at MilliporeSigma's viral vector CDMO in Carlsbad, CA, emphasizes, "Fill-finish is the final step before the product goes to the patient. It's among the more important steps in CGT manufacturing, since it directly impacts the final product's quality, sterility, potency and homogeneity, and all of these matter for patient safety."

Essential Capabilities for CGT Fill-Finish Operations

Industry experts have identified five key capabilities that CGT developers should seek in a fill-finish CDMO partner:

1. Understanding product stability at ambient temperatures
2. Protecting against product loss
3. Maintaining robust contamination controls
4. Keeping up with global compliance requirements
5. Maintaining state-of-the-art equipment, facilities, and supply chains

Erik Amundrud, head of manufacturing and MSAT for MilliporeSigma's viral vector CDMO, notes the importance of product stability studies: "Their limited stability means the entire drug product operation—from formulation to fill, visual inspection and labeling, all the way through reconciliation—needs to be highly efficient to minimize titer loss."

The high material costs and small batch sizes of CGTs make minimizing product loss crucial. Advanced fill-finish systems with ultra-short flow paths, precision pumps, and reduced-diameter internal tubing can help achieve this goal. Additionally, maintaining robust contamination controls through the use of isolators and closed-system, single-use assemblies is essential for ensuring product integrity.

As the CGT industry continues to evolve, staying compliant with global regulatory requirements remains a top priority. CDMOs must operate in a state of constant audit- and inspection-readiness while helping clients navigate container, closure, and product labeling requirements across different markets.

The CGT manufacturing landscape is rapidly advancing, with a growing emphasis on specialized expertise in viral vector therapeutics. As the industry moves forward, partnerships between developers and experienced CDMOs will play a crucial role in bringing these innovative therapies to patients safely and efficiently.