Nirupama (Rupa) Pike, PhD

Dr Rupa Pike, Sr. Director & Global Head Strategic Alliances and Field Scientists for Cell Therapy, Catalent, shares insight on de-risking cell therapy programs using streamlined development and manufacturing platforms.

From Early Development to Commercialization: Strategies for Successful Cell Therapy Manufacturing

Manufacturing is a critical component in the development of cell therapies, and implementing de-risking strategies early in the process is essential to ensure product safety, efficacy, and alignment with regulatory requirements. De-risking encompasses identifying and addressing potential safety and manufacturing challenges, such as variability in raw materials or inefficiencies in processes, to reduce technology transfer issues and clinical development setbacks. Early-stage strategies like Quality by Design (QbD) principles, gap assessments for regulatory compliance, and thoughtful planning around vendor selection, raw materials, and manufacturing technologies contribute to smoother clinical progression and commercial readiness. These measures also lead to time and cost savings, ultimately improving the likelihood of successful IND approval and clinical manufacturing initiation.

To address manufacturing challenges specific to CAR-T therapies, Catalent has developed the UpTempo℠ CAR-T platform, a flexible and customizable solution built from experience with over 500 manufactured batches across 20+ cell therapy programs. This platform leverages GMP-compliant manufacturing equipment, ready-to-use raw materials, and a robust suite of analytical tools to streamline processes and ensure quality. It supports two approaches: transferring existing processes into the UpTempo℠ ecosystem for optimization or utilizing Catalent’s standardized workflows for efficient manufacturing. The platform's flexibility and instrument-agnostic design enable integration of the latest technologies, reducing costs, accelerating timelines, and enhancing therapy accessibility.

Navigating regulatory requirements throughout the manufacturing process requires early and proactive engagement with authorities like the FDA. Interact and pre-IND meetings provide critical feedback on product development expectations, including manufacturing and quality controls. Sponsors benefit from guidance on preclinical models, CMC readiness, and expedited approval pathways, which have been instrumental in bringing commercial cell therapies to market. Maintaining compliance through clinical phases and addressing country-specific regulatory requirements are crucial to ensuring product safety, quality, and consistency. Catalent’s global regulatory affairs team supports sponsors from pre-IND submission through commercialization, ensuring adherence to evolving regulatory standards.

Integrating advanced analytics and data-driven insights into cell therapy manufacturing enhances efficiency and decision-making by enabling real-time monitoring of critical process parameters (CPPs) such as cell health, proliferation, and functional properties. Catalent’s UpTempo℠ platform incorporates innovations like microfluidics-based automated flow cytometry and rapid sterility strategies, reducing analytical testing time and accelerating batch release. Emerging technologies such as non-invasive sample analysis, cloud-connected inline tools, and embedded sensors further optimize monitoring and control. The application of AI and machine learning is also beginning to play a role in predictive modeling, complementing current tools to accelerate product release and improve manufacturing outcomes. This data-driven approach supports process optimization, quality assurance, and commercialization efforts, paving the way for broader accessibility of cell therapies.

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Dr Rupa Pike, Sr. Director & Global Head Strategic Alliances and Field Scientists for Cell Therapy, Catalent, shares insight on de-risking cell therapy programs using streamlined development and manufacturing platforms.


Nirupama (Rupa) Pike, PhD

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