The lucrative cell and gene therapy (CGT) market is poised for dramatic growth that will likely drive revenues to nearly $37 billion/year by 2027.1 Many companies who are actively moving forward in CGT work with contract development and manufacturing organizations (CDMOs).
“We anticipate major breakthroughs coming soon from companies with new and innovative CGT technical platforms,” reports Yangzhou Wang, PhD, CEO, Porton Advanced Solutions, a custom gene and cell therapy CDMO. Porton Advanced is a subsidiary of Porton Pharma Solutions, a globally recognized small-molecule CMDO.
Wang continues, “Because CGT CDMOs require heavy investment in infrastructure and people, they can be the perfect partner, especially for smaller startups. For example, they can greatly assist in process development, establishing rigorous analytical development, enhancing critical quality control (QC) and release measures, and providing scale-up/scale-out and regulatory compliance support in different markets.”
Porton Advanced is an end-to-end CDMO provider with a global reach. Wang advises sponsor companies considering a CDMO partnership to begin the process sooner than later: “For CGT companies, many functional assays in the efficacy stage and other preclinical stages can greatly impact later-stage chemistry, manufacturing, and controls (CMC) and associated analytical development. It’s always better to start early rather than later in establishing such a partnership.”
However, not all CDMOs are alike, warns Wang: “Clients should assess a company’s overall ‘capabilities and capacities.’ While these are industry buzzwords, the idea is for teams from both companies to discuss current needs and potential technical nuances that could affect anticipated scale-up.”
A second criteria is to evaluate the CDMO’s assay and process development programs. Wang advises discussing specific functional assays needed: “Does the CDMO have these in place, or can they be developed with the client’s protocol? Assays could be, for example, cell-based, physical-chemical based, structure-based, potency-based, process-related, safety tests or stabilities studies.”
Porton Advanced has a wide spectrum of services suitable for preclinical/ and clinical phases, and for commercial cell and gene therapeutic products.
Wang also suggests evaluating the CDMO’s quality systems: “This can be highly variable among companies. It’s important to assess how rigorous are the manufacturing systems, facility utility and equipment systems, and material systems.” Porton Advanced teams tailor the client’s manufacturing needs with strict attention to CMC protocols to ensure product safety and batch consistency.
Finally, Wang recommends scrutinizing the customer service afforded by the CDMO: “At Porton Advanced, we believe partnering with a CDMO is a long-term team experience for both the client and provider. We have versatile platforms including viral vectors, different cell therapies, adeno-associated virus (AAV), oncolytic virus, and mRNA-based production units. With our diverse platforms and experience, we invite discussions for not only understanding the technical aspects, but also for determining the best path toward a sponsor’s CMC objectives. We recognize that each company has its own needs and nuances, making flexibility and adaptability from its CDMO partner a necessity.”
Wang says the ultimate goal, naturally, is to advance the product all the way to manufacturing, i.e., entering the current good manufacturing practices (cGMP) phase. He advises, “At Porton Advanced, we currently have two state-of-the art cGMP facilities (a total of 140,000 square feet) with hundreds of classified clean rooms. We also have multiple production suites for cell therapy, AAV, lentiviral vectors, virotherapies, and mRNA. All of these are monitored by more than a dozen QC labs.”
Wang says to avoid costly changes later, choose a CDMO carefully. “At Porton Advanced,” he declares, “we strive to build long-term relationships and want to earn the trust of our clients. Anything good in life requires attention, and we pay great attention to details. We want to play a small role in each of our clients’ journey to become the next big company that will improve human health.”
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