IMCPL is committed to pioneering scalable and reproducible cell and gene therapy (CGT) manufacturing from concept to clinical manufacturing. Our expertise lies in structured project onboarding and in-depth CMC scrutiny, ensuring that process and product quality is well controlled before therapies advance to clinical trials.
Challenges in CGT Manufacturing
- Scalability Failures
A significant issue in CGT manufacturing is that many developers operate under a venture-capital-backed funding model, focusing on early-phase data generation rather than designing robust, scalable, and reproducible manufacturing processes.
- Manual Processes & Lack of Standardization
Many early-stage CGT processes are developed in academic settings or small biotech labs, where workflows remain manual, variable, and inconsistent.
The absence of automation and process control leads to high failure rates when transitioning to large-scale production.- Inadequate Sampling & Risk Management
Limited in-process controls (IPCs) during early-stage development fail to identify critical CMC risks related to cell variability, viral vector integrity, process and product-related impurities, and product potency. Scaling up without robust statistical process control can introduce significant batch-to-batch variability, affecting therapeutic efficacy and patient safety.
- Product Homogeneity
The challenge of ensuring consistent product quality across multiple production runs is heightened in CGT, where live-cell therapies are inherently complex. The impact of raw material variability, cell source heterogeneity, or differences in bioreactor scaling combined with failure to qualify critical material often leads to failed late-stage trials.
- Failure to Plan for Scalability & Reproducibility
Many CGT developers prioritize early-stage proof-of-concept over commercial feasibility, only realizing later that their process is overly hands-on and cannot be scaled efficiently. By the time these companies attempt process scale-up, time and funding constraints make it challenging to redesign their manufacturing systems for efficiency and control.