Omkar Kawalekar, eminence lead of NextGen therapies at Deloitte Consulting, moderated a panel of experts who discussed how to build a collaborative distributed autologous cell therapy manufacturing ecosystem.
Kawalekar, who characterized distributed manufacturing as being in its infancy, asked the panelists about what factors have held the industry back from adopting a widespread distributed model. Peter Peumans, CTO Health at imec, a technology research and innovation company, discussed his work with semiconductors alongside the life sciences industry. He related the question to a story from his own work experience in technology development.
“Before the industry learned how to work together, every company that made chips developed their own machines and their own processes in house. At some point in time it became clear it was too expensive for any one company to bear. So they started collaborating as a way to reduce the risk and costs of a new generation of technology.”
“It was an economic necessity for the industry to continue to exist.” He related his point to the growth of distributed manufacturing, emphasizing that the economic pressure pushing the industry to provide therapies at low costs will drive it toward change.
Amol Ketkar, chief manufacturing and technical officer of cell-therapy company Resolution Therapeutics, said that distributed manufacturing is important for achieving access for patients. “You need to be able to manufacture this medicine in different places on different continents with different labor forces,” he said, thus moving away from niche manufacturing strategies that have served the industry in the past.
Although it may be in its infancy, distributed manufacturing has gained a foothold. “Distributed production of cell and gene therapies (CGTs) is a reality,” said Vered Caplan, CEO of Orgenesis. She added that the clinical landscape has necessitated distributed manufacturing, because hospitals can’t cannot otherwise get medicines to patients fast enough.
As companies search for ways to ease the transition to distributed manufacturing, technology will play a big role. Ketkar discussed the value of having a quality management system across a company’s distributed network, enabling enhanced data generation and learning. He also said that automation can enable companies to stabilize some of the variable elements that go into manufacturing.
Kawalekar cited data as an important foundational element that must be captured, preserved, and accessed to create the algorithms necessary for complex functions, such as those provided by artificial intelligence (AI). Caplan added that proper data collection helps to ensure consistent production processes while also streamlining regulatory processes.
And for smaller biotech companies such as Resolution Therapeutics, it’s especially important to plan distribution networks and meet with regulatory organizations early to prepare for challenges in scaling, which often involves moving manufacturing operations from small-scale academic institutions to larger facilities.
Caplan added that distributed manufacturing will improve as the industry evolves. She said, “It’s about making sure the industry is open, collaborative, and working together.”
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