Seamless Integration in Gene Therapy Process Development
A contract manufacturer running multiple adeno-associated virus (AAV) programs says early engagement between key stakeholders, proactive risk assessments and platform knowledge is core to the successful delivery of gene therapies. The post Seamless Integration in Gene Therapy Process Development appeared first on GEN - Genetic Engineering and Biotechnology News .
The manufacturing question surrounding adeno-associated viruses (AAV) for gene therapies has transitioned from feasibility to consistency. Forge Biologics, a contract manufacturer specializing in AAV production, emphasizes the need for consistent manufacturing. Associate director of upstream process development Sumit Dutta highlights the industry's increasing focus on process robustness and timely product market entry.
Forge Biologics, which handles multiple AAV programs, aims to identify patterns and learn from them, focusing on reducing risk and seamless integration between early- and late-stage clinical programs. They engage key stakeholders early to ensure alignment on development goals and target. Critical process parameters and quality attributes are identified and studied using high throughput scale-down models.
Regulatory guidelines from the U.S. Food and Drug Administration (FDA) are integrated throughout the development process. Dutta will discuss Forge Biologics' late-stage development approach at the Bioprocessing Summit in Boston.
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