October 22, 2021 -- On the second day of the Cell & Gene Meeting on the Mesa, Betty Woo, PhD, vice president and general manager of cell and gene therapy (CGT) at Thermo Fisher Scientific, led a workshop titled "Industrialization of Cell Therapy Manufacturing -- Lessons Learned From Biologics." ScienceBoard.net caught up with Woo following the workshop.
Thermo Fisher wanted to "relay some of the advances happening in biologics manufacturing and see what could be applied in the cell and gene therapy space," Woo said. Woo invited a panel of seasoned industry veterans and probed them on important topics relating to closed systems of cell therapy manufacturing, physical and digital automation, and the supply chain.
The cell therapy industry is at an inflection point, Woo said. Today, cell therapy manufacturing is primarily small-scale for autologous products. These systems are open, manual, and prone to errors, she said. Moving forward, technology must be scaled to make therapies affordable for patients.
Woo also described the role that Thermo Fisher's cell and gene therapy products serve in the marketplace. Thermo Fisher's fit-for-purpose comprehensive portfolio includes documentation, quality standards, and regulatory elements, which are currently being used in over 200 clinical trials. Some of Thermo Fisher's more general products, such as culture media, can also be modified as fit for purpose as needed for cell therapy products, Woo explained.
Thermo Fisher's contract development and manufacturing organization (CDMO) business, which provides services to cell therapy customers, is an internal, totally transparent partner that informs CGT clients if products are meeting their needs. This feedback cycle enables rapid prototyping and iterations, which Thermo Fisher uses to provide customers with fit-for-purpose products. With this model, Woo stated, Thermo Fisher can serve customers when they are in the "buying" stage of manufacturing (CDMO services) all the way through to when they transition to the "building" stage (bringing manufacturing in-house).
"We are all trying to find that secret sauce that's going to yield robust, safe outcomes for patients," Woo responded, when asked about obstacles in the industry. She cited standardization and collaboration as the top challenges.
While standardization, partnership, and digitization are challenges facing the industry, Woo said, they are also achievable common goals.
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