The Role of cGMP Chemicals in Cell & Gene Therapies

Sponsored by Avantor

December 16, 2020

Improvements in raw material inputs are necessary in order to deploy cell & gene therapies economically and at scale. Watch an on-demand webinar featuring Avantor experts to learn about challenges associated with using non-GMP raw materials, as well as tailoring single-use systems to the unique manufacturing requirements for these therapies.

Timothy Korwan, Director, New Product Development – Single-use
Wayne Lynch, Product Manager

Today’s biologic drugs give the promise of breakthrough treatment options for the world’s most challenging diseases and chronic conditions. Rapid developments and product approvals in cell therapies and gene therapies over the last few years have brought transformative medicines to market to improve patient well-being globally.

The impact of cell therapies and gene therapies will expand as they are administered to larger patient groups and studies expand to address diseases that are broader- reaching. While some lessons learned can be adapted from manufacturing monoclonal antibodies, vaccines and other biologics, commercializing these products have introduced a unique new set of challenges for the industry to address.

The demand to accelerate commercialization timelines is pushing manufacturers to implement lab-scale processes in commercial-scale operations, often using non-GMP materials and methodology adapted from clinical settings, which is neither efficient nor effective in the long run. Manufacturers must pay close attention to their processes in order to understand and reduce contamination risks, maintain consistent product quality throughout the process (including in delivery to the patient), and ensure global continuity of supply for all patients.

Many current cell and gene manufacturing processes are manual and labor intensive, particularly around fluid management and sampling, with an estimate of three-times more hands-on operations than for traditional biologic manufacturing. In the case of an autologous cell therapy and some gene therapy processes, the working volumes can also be quite small with poor yield. Understanding this early in process development can be critical in how the processes are scaled in a production setting; for example, identifying manual operations that are being performed inside a biological safety cabinet.

Improvements in raw material inputs and innovations in manufacturing technology are necessary in order to deploy cell and gene therapies economically as well as at scale, if cell and gene therapies are to reach their true potential. For example, new fluid pathways using single-use technologies can be designed to move liquid from unit operations while maintaining sterility and integrity through scale-up. Further, the importance of using cGMP chemicals and excipients and single-use technologies manufactured by reputable suppliers with well-documented, robust quality programs and supply-chain risk mitigation programs cannot be understated.

In a recent webinar, Understanding the critical roles of cGMP chemicals and single-use technologies in cell & gene therapy manufacturing, Avantor experts discuss the challenges associated with using non-GMP raw materials and excipients and how tailoring single-use systems and technology to the individual manufacturing requirements in the sampling process helps to improve workflows, reduce risks and save money.