As medical institutions develop the infrastructure for decentralized manufacturing of cell therapies, they are positioned to outperform big pharma’s limited success with a centralized approach to manufacturing.
Advances in manufacturing infrastructure will enable institutions to play a more substantial role in the value chain of living medicines, from research to commercial products. Indeed, once the manufacturing infrastructure is in place, we will likely see elite medical centers and their manufacturing partners, rather than big pharma, become the major players in the development and commercialization of cell and gene therapies.
Over 9,900 cell therapy trials are currently recruiting. No doubt many of these trials will fail, but if the past is any guide, five to ten percent will succeed, meaning a significant number of cell therapies will be approved soon. In an often-quoted statement, the former commissioner of the Food and Drug Administration (FDA), Scott Gottlieb, predicted that, by 2025, the FDA would approve between 10 and 20 cell therapies per year. This is an extraordinary number when considering that the total number of drugs approved in a single year over the last ten years has averaged around 40. This opportunity is being recognized by investors, who pumped €17.7B ($20B) into cell and gene therapies in 2020, eclipsing the total invested in 2019 and ending up nearly 50% higher than the previous record of €12B ($13.5B) set in 2018.
However, the main challenge for most cell and gene therapy programs is the lack of distributed manufacturing infrastructure that would allow the translation of cutting-edge cell therapies into affordable treatments that are available to patients anywhere. Big pharma has attempted to solve this with massive investments in centralized manufacturing. Catalent has recently bolstered its centralized manufacturing by spending over €1.3B ($1.5B), acquiring the CDMOs Paragon Bioservices and MaSTherCell, while both Novartis and Kite have purchased or built major manufacturing facilities.
However, this capital-heavy approach is a dead end. Economically, it doesn’t work; the cost of centralized, manual processes will keep therapies out of reach for patients and payers. A recent example was bluebird bio’s withdrawal of Zynteglo, a gene therapy for a rare blood disorder, from the German market because it could not agree on a price with the health authorities. This centralized approach also doesn’t work from a clinical perspective because of complicated logistics, time lags, and failed batches.
With the right manufacturing and data infrastructure in place, these elite medical centers can also become therapeutic developers. With the ability to produce consistently and comparably across stages of development and geography, they will be able to get approval of their therapies and market them. The entire connected network of distributed manufacturing will be able to spread learning instantly to ensure maximum safety and efficacy. For example, a large medical centre in Lagos, Nigeria could be using the latest bioprocessing innovations developed at MD Anderson the day before. And MD Anderson could benefit from the data created in Lagos.
To continue reading the full article by labiotech.eu: Distributed Manufacturing of Cell Therapies Poses a Threat to Big Pharma (labiotech.eu)
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