Gene And Cell Therapy Analytical And Development Methods: A Path To Success

The gene and cell therapy (GCT) industry has rapidly evolved over the past 30 years. By modifying patients’ cells to correct underlying genetic problems, gene therapies can provide long-term treatment — and potentially curative — options for previously untreatable diseases. By 2027, the global gene therapy market is predicted to grow at a compound annual growth rate of 18.6% to reach a value of $17.2 billion. However, this time of expansive growth also brings a great number of needs.

As sponsors aim to advance their therapeutic products through clinical stages toward commercialization, identifying effective processes and analytical development strategies that can support the evolving challenges to overcome the needs of the industry and deliver quality therapies to patients aids in meeting developmental milestones efficiently with the potential to accelerate timelines. Identifying a manufacturing partner with expertise and experience in navigating the needs of GCT process and analytical development eases the burden of regulatory compliance and troubleshooting novel issues. The right CDMO will also offer the capabilities, facilities, and strategies needed to successfully progress therapies from preclinical phases to commercial at pace.

Download the white paper in PDF to learn more about the importance of implementing the right development approaches early in the product life cycle and how analytical method choice impacts the delivery of safe and efficacious GCTs to the market.