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In the third part of this special focus on mRNA manufacturing, In Vivo looks at the many directions mRNA platforms can expand, with a major focus on optimizing cellular microenvironments for safety and efficacy.
Despite a raft of measures to prevent substandard or falsified (SF) medicines from reaching individuals, these medicines proliferated with the growth of e-commerce during the COVID-19 pandemic. The problem requires multistakeholder counter efforts, and for providers and patients to change their behaviors.
In the second part of In Vivo's series on mRNA manufacturing, we look at the technology behind the Moderna and Pfizer/BioNTech COVID-19 vaccines. Experts in the field are working on a variety of improvements that will enable quicker, cheaper, surer development and production of what could turn out to be a wide array of vaccines and therapeutics to be churned out by emerging mRNA platforms.
In the first of a three-part series on the evolution of mRNA manufacturing, this article looks back to before the pandemic, when dogged mRNA researchers and entrepreneurs labored in obscurity pursuing the dream of revolutionizing health care by commandeering the body’s own protein building process to generate quicker, cheaper vaccines and therapeutics. Then the mRNA COVID-19 vaccines stunned the world.
Drug manufacturers have been feeling the crunch from global supply chain issues, but the FDA will accept no excuses when it comes to quality and safety. How can manufacturers prepare for proposed changes to quality measurement requirements?
Biogen, Amgen, Lilly and Genentech experts shared tales of impending stockouts, particularly for single-use assemblies, filters and resins, and some of the measures they took to prevent them from causing drug shortages.
The formulas for various COVID-19 vaccines remain shrouded in intellectual property protections – one of many factors preventing them from being manufactured in developing nations. Those in favor of upholding IP say that scrapping patents could stifle future innovation, but their opponents believe preserving COVID-19 related IP rights is limiting access to lifesaving medical tools.
Advanced Therapies have come a long way over the past decade. Some cell and gene therapies have already been approved and others have now entered the later stages of development and this is reflected in a shift towards later clinical trials. In consequence, manufacturing process consistency, GMP standards, etc., must now meet more formal requirements. This brings some challenges because the products, and their development and manufacturing processes, differ from traditional models.
HHS agencies look to build on COVID-19 experience by developing quicker public/private responses to pandemics and supply chain threats.
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