Thursday, October 1, 2015

Poor process is hampering cell therapy commercialization

Attendees queue out of the door to hear a panel discussion on alignment with commercialization
In a panel session on alignment with commercialization, attendees at Cell Therapy Bioprocessing & Commercialization were quite literally queuing out of the door to hear the discussion.

Session chair Robert Preti PhD, president of PCT, a Caladrius Company, posed the question of whether a cell therapy product was the process. “Yes and no,” he said. “It’s actually much more than that. But what does define the product?”

He told attendees that a cell therapy product has to be “transformative, have a robust manufacturing process, have the right business model, optimize COGS, must be scalable, logistically practical, clinic friendly and reimbursable”.  “Ultimately a product has to be deliverable,” he said.

However, he stressed that cell therapy products are difficult to deliver compared with a pill. “The benefit derived must overcome the natural tendency to prescribe what is easier to deliver (ie a pill).”

He said one of the main challenges in creating a commercial future for cell therapy was to change and improve the manufacturing model. “It’s a complicated model, but we know it needs to change.  It’s an enormous challenge.  A manual manufacturing process will fail,” he added.

He challenged the panel to answer how to prioritize improvements to the process “to limit the need to go backwards and repeat trials”. 

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