Lifecycle Approach Could Solve CGT Scale-Up Challenges
Cell and gene therapy developers often struggle to scale manufacturing, according to the authors of a new review, who suggest that part of the problem is the practice of developing unit operations in isolation. The post Lifecycle Approach Could Solve CGT Scale-Up Challenges appeared first on GEN - Genetic Engineering and Biotechnology News .
Scaling cell and gene therapy (CGT) manufacturing remains a significant hurdle for the industry, according to a new review from researchers at Manipal Academy of Higher Education in Karnataka, India. The team argues that treating manufacturing, analytics, and regulatory compliance as separate components is a primary reason for the sector's scalability challenges. Historically, different groups have focused on specific aspects of CGT production, rather than viewing the entire product lifecycle as a unified system.
Study co-author Sachin Dattram Pawar, PhD, suggests that scalability should be integrated from the beginning, using lifecycle-oriented tools to embed flexibility into the process as development progresses. This approach would enable manufacturers to manage knowledge continuously throughout the product's lifecycle, instead of addressing manufacturing issues separately after production has begun.
Pawar highlights the potential of decentralized systems, such as the CliniMACS Prodigy or Lonza Cocoon platforms, which feature closed and automated manufacturing systems, real-time process monitoring, and advanced analytics. He also points to emerging technologies, including digital twins, AI, allogeneic and iPSC-derived platforms, and improved vector production technologies, as potential solutions for enhancing scalability and consistency.
Furthermore, a lifecycle-based manufacturing approach aligns with evolving regulations, such as ICH Q12, the FDA's flexible CMC approach for CGTs, and the EMA's PRIME scheme. These regulations support a more risk-based, lifecycle-oriented approach that promotes innovation while maintaining product quality and patient safety.
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