BioPharm International - September 2022

BioPharm International - September 2022

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4 BioPharm International ® Emerging Therapies 2022 eBook M edicines have existed since the beginning of time—from what nature provided to the evolution of modern science. There has been a rapid evolution of APIs over the years, driven by innovation with different thera- peutic modalities, which, due to varying challenges, require manufacturers to continuously learn and op- timize their design processes. From antibodies to vi- ral vectors to messenger RNA (mRNA) to oligos, each modality comes with its own ecosystem for manufac- turing that requires the flexibility to grow quickly. It's not just about the molecule mRNA. It's the right molecule at the right time. Thanks to the rapid devel- opment of mRNA vaccines for COVID-19, the industry now has the momentum to overcome the challenges to realize the enormous potential of this technology. Long before COVID-19, a small group of dedicated scientists and researchers had been studying and ad- vancing this technology for cancer and other diseases. It took more than 30 years to overcome obstacles, such as mRNA destruction by chemicals in the blood. For- tunately, for the pandemic, scientists figured out how to teach the immune system cells to consume mRNA without drastic immune reactions. Now, innovation is accelerating the development of these therapeutics. With proven potential, the indus- try will see the creation of new molecules that will hopefully lead to improved treatments for patients. With these advancements come process challenges and the need to build resilient and f lexible manu- facturing strategies that can adapt to the changing needs in a nascent industry. Benefits of mRNA therapeutics It may take years to reach the next breakthrough in nu- cleic acid-based therapeutics, but the potential for mRNA technology to transform global healthcare is enormous. There are some distinct benefits to the technology: • Speed. Most traditional vaccines against viral diseases are grown in chicken or mammalian Accelerating the Development of mRNA Therapeutics Scott Ripley is the general manager, nucleic acid, for Cytiva. Manufacturing and processing challenges surrounding mRNA can be overcome in order to realize the true potential of a technology 30 years in the making. DAN RACE - STOCK.ADOBE.COM

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