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Rupa Pike

Thermo Fisher Scientific

As the Head of Technical Operations at Patheon, Rupa oversees the strategic initiatives and solutions for process development (PD) of GMP grade Cell Therapy products. She spearheads technical training and works closely with partners and clients to conduct technology transfer and process optimization activities. Rupa also leads the efforts to build novel Cell Therapy workflows that will advance PD and GMP manufacturing service offerings at Patheon.

Prior to re-joining Thermo Fisher, she worked as the Director of Cell Manufacturing for UW Program for Advanced Cell Therapy. She was part of the leadership team at WiCell Research Institute that pioneered the early human embryonic and induced pluripotent stem cell research under the leadership of Dr. Jamie Thomson. Rupa developed the Stem Cell Training Course which has served over 800 scientists from 32 US states and 20 countries. At Ligand Pharmaceuticals, she was part of the team that designed novel hematopoietic screening assays for erythropoietin and thrombopoietin in partnership with GlaxoSmithKline, a part of the program that led to development of Promacta®. In her past roles, Rupa has successfully managed R&D laboratory operations, Manufacturing Science & Technology (MSAT) operations, technical training,

infrastructure development, customer relations and business development. Rupa holds a Masters degree in Biology from Loyola University and a Doctorate from Harvard University.


Transitioning from Cell and Gene Therapy Discovery and Development to Manufacturing - Challenges and Opportunities

Abstract

Cell and Gene Therapies (CG&T) hold the promise of transforming medicine and human health. The recent commercial success of cell therapy products has generated a tremendous excitement and acceleration of new product development in this arena. Currently, over 400 therapies are in pre-clinical to Phase 3 development, and approximately 1,700 clinical studies are underway globally. As CG&T manufacturing processes evolve to meet regulatory, economic, and patient safety needs, a seamless transition from pre-clinical to GMP manufacturing is critical for their success.

Academic and hospital-based research and development programs play a major role as a source of innovation for new CG&T products. The need for technology transfer and process improvement is foundational as companies acquire licenses for CG&T products from academic centers. The statement that the “process is the product” is particularly true for cell therapies since cells are living pharmaceuticals. The overall success of transitioning the product from development to clinical trials, and ultimately to commercialization, is entirely dependent upon a safe, robust, well-characterized and reproducible process. Scientists can achieve this goal by addressing issues related to raw materials, analytical methods, scalability, personnel training and early incorporation of quality standards. Adopting steps for early process optimization and control will result in manufacturing therapies that meet regulatory requirements and are economically viable at industrial scale.