Developing Cell Therapy Manufacturing Processes

As a lead in to the upcoming Cell & Gene Therapy Bioprocessing & Commercialization conference this October, members of the expert speaking faculty have been kind enough to join the KNect365 Bioprocessing team to discuss hot topics, key innovations, major disruptors and more across the industry.

In today’s volume, Ravi Bhatia, Scientific Director, PDMS at Janssen R&D discusses his start in the cell therapy industry, collaboration and innovative thinking to solve process challenges, autologous CAR-T products, the manufacturing process, and the upcoming conference where he will be presenting a session titled, “Scale-Up of an Allogeneic Cell Therapy Product”.

Prior to joining the cell therapy industry, what do you wish you had known?

RB: When I started to work on cell therapy products nine years back, I realized that there were limited off-the shelf technologies available from vendors that were suitable for cell therapy applications. Therefore, it became imperative to form an alliance with external companies to develop the innovative manufacturing technologies. Furthermore, cell-therapy based products are so diverse because of different type of cells used for different therapeutic applications so the available process technologies may not directly apply to the cell therapy product that you are developing. Therefore, collaboration and innovative thinking to solve process challenges are critical to develop cell therapy manufacturing processes.

What upcoming major trends are you excited about?

RB: Autologous CAR-T products have shown efficacy in clinical trials and I am very excited to see these products launched in the near future to meet unmet medical needs. However, the manufacturing and supply chain of the autologous product can be very complex. Because of this, the next wave of the products could be allogenic CAR-T products, which can be produced in large quantities from a single batch.

What are the key innovations in cell processing that will help accelerate the pathway to approval for cell and gene therapies?

RB: The development of robust and high throughput methods to characterize the product (cells) will be the next driver to accelerate process development and regulatory approval. The methods to characterize a cell therapy product will drastically improve the understanding of the mechanism of action and the effect of process conditions and materials on the product quality, which is important to develop a robust manufacturing process.

What is your biggest concern when it comes to the regenerative medicine industry today?

RB: My biggest concern is manufacturing process, which consistently meets product quality attribute, and supply of cell-therapy based products once the products are approved. Cell-therapy based products are not well characterized therefore it is imperative to have a good understanding of process conditions that could impact product quality. In addition, supply of cGMP grade raw materials and consumables is essential for the production and supply of a cell-therapy based product.

What is the “secret sauce” to success in your opinion?

RB: Engagement of process scientists in product development cycle as early as possible is essential to take a potential therapy from discovery to clinical trial and commercial. With involvement of process scientists early in the product development cycle, they have an opportunity to influence the scientists in the Discovery organization to select technologies which are scalable and amicable to cGMP manufacturing.

Do you have any best practices or success stories you’d like to share?

RB: As I mentioned earlier, collaborations between drug development companies and external vendors are imperative for development of innovative technologies to manufacture innovative products such as cell-therapy based products. One success story that I would like to share is the collaboration between Janssen R&D and kSep systems to develop a fluidized bed centrifuge technology for cell concentration and cell washing application. kSep Systems had a patent on a fluidized bed centrifuge (FBC) and had a prototype centrifuge but the technology was not scalable and not single-use. Janssen and kSep collaborated to develop a scalable centrifuge which is completely single-use and fully automated. Today, the FBC technology has become a platform technology for cell concentration and cell washing for cell-therapy based products within the industry.

What do you hope to learn more about at the Cell & Gene Therapy Bioprocessing & Commercialization conference?

RB: I would like to hear more about challenges, and case studies on process development and scale-up of different types of cell therapy products. In addition, I am very interested in hearing more about late stage product development and a path to regulatory approval of cell-therapy based products.

 

To hear more from Ravi and other industry experts, join us this October 5-7 in Boston, MA for Cell & Gene Therapy Bioprocessing & Commercialization. Click here for more details.

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