Cell and gene therapy developers and biopharmaceutical firms with diverse product pipelines lead the way when it comes to adopting innovative manufacturing technologies. Generally speaking, biopharma is reluctant to use advanced manufacturing methods. For many firms, the risks associated with novel technologies outweigh the benefits, according to Kelvin Lee, PhD, Gore professor of chemical & biomolecular engineering at the University of Delaware.
“There is a challenge around barriers to adoption of innovations into commercial manufacturing. I think it’s fair to say that many more innovations have been proven out in development, than have seen the light of day in commercial operations,” he says. “Along those lines, there are business risks, which are sometimes expressed as regulatory risks, associated with adoption of novel technologies in that these technologies have the potential to slow time to market.”
Pipeline drivers
But within biopharma as a whole some sub-sectors are willing to take a risk on manufacturing innovation, notes Lee, citing drug makers with diverse candidate product portfolios as an example.
“I would argue complexity of the modality is one issue but that is also connected to complexity of development portfolios, i.e., portfolios that have monoclonal antibodies, bispecifics, gene therapies, cell therapies, and others,” he explains.
For firms with a large array of product types, having a flexible and efficient manufacturing operation is vital. And this makes such companies more likely to invest in new technologies.
“Development teams and companies are challenged to get to market as quickly as possible,” Lee tells GEN. “Of course, maintaining quality is also essential in bringing products to market.”
Cell and gene therapy all in on novel platforms
Cell and gene therapy developers are another group interested in novel manufacturing methods, says Lee, who likens the high-level demand to that seen during the early days of the monoclonal antibody-based drug sector.
“The convergence on platforms–mAbs expressed from CHO and purified with capture chromatography–has helped drive the industry to better understand aspects of the process and helped suppliers and supply chains address more common needs and interests,” he continues.
“Many of the people that I communicate with talk about how the cell therapy community, and also the gene therapy community, want to see the type of maturation and convergence of manufacturing platforms that benefited the antibody community.
“There is a lot of discussion about how to accelerate the ability of those communities to converge as quickly as possible by taking the learnings and understandings from the mAb community.”
And as the speed, quality and cost benefits of innovative technology become clear, the wider industry is likely overcome its reluctance, according to Lee, who looked at the evolution of biopharmaceutical manufacturing in a recent study.
“Facilities in the future will be flexible, they will be smaller footprint and more environmentally sustainable, they will handle multiple product types, and significantly leverage data-driven approaches to process control, product release, and facility and operator management,” he says, “There will certainly be more automation.”
For recent GEN articles on cell and gene therapy, see “Cytiva and Bayer Agree to Collaborate on Allogeneic Cell Therapy Manufacturing Platform” and “Matica Bio Opens New Cell & Gene Therapy GMP Facility in Texas.”
