The Critical Role of Excipients in the Coronavirus (COVID-19) Fight

Excipients & Vaccines

Excipients play a critical role in the development of new biopharmaceuticals, pharmaceuticals, and vaccines to fight coronavirus and other diseases

As companies rush to develop new biopharmaceuticals, drug products, vaccines, and re-purpose older drug products to fight COVID-19, the importance of the critical function excipients play in these products cannot be forgotten.

Artificial intelligence has been used to rapidly identify molecules that could form the basis of an effective treatment against the coronavirus at the heart of the current outbreak. In fact, thousands of new molecules have been identified that could be turned into potential medicines against the virus.

The global health emergency over the spread of the deadly new coronavirus, known as 2019-nCoV, is proving to be a crucial real-life test case for a host of new biomedical technologies, as well as new organizations and funding bodies, that aim to dramatically reduce the time it takes to create new vaccines and drugs to combat emerging pandemics.

The idea is to find and test new treatments, putting them into human clinical trials in as little as a week or two, as opposed to the years it might otherwise take. U.S.-based biotechnology firm is set to begin immediate human testing of an existing antiviral drug, remdesivir, in Wuhan, the heart of the coronavirus outbreak.1

Excipients play key roles in biologics, but there are many challenges in biologics and vaccine formulation, including stabilization during processing and storage. Biologics and vaccines are inherently unstable and prone to degradation by several physical and chemical degradation mechanisms. Therefore, a variety of excipients are required to stabilize biologics and vaccines during processing and storage. Selection and use of the appropriate excipients enable development of novel therapies and robust pharmaceutical products.2

Purified water has been a vital excipient for the development of the COVID-19 vaccines. Water purification systems help to generate the massive amounts of purified water necessary for producing and packaging vaccines on this sort of scale. In the United States alone, a population of over 330 million people necessitates the creation of at least 660 million doses of COVID-19 vaccine. Right now, millions of gallons of pharmaceutical-grade water are produced a day, much of which is being funneled directly into vaccine testing and production.3

Now, more than ever, it is vital for formulators, scientists, chemists, quality and other professionals involved in the development of drugs, biologics and vaccines to stay abreast of the latest FDA regulations, drug delivery advancements and the evolving global supply chain. It is critical that new products be developed quickly, but demonstrate they are safe and effective.

IPEC-Americas provides year-round learning opportunities focused on the vital role of excipients in drug and healthcare product manufacturing. IPEC-Americas presents year-round and ongoing opportunities for education, including webinars, white papers, research papers, guidance documents and the Excipient World Conference & Expo, which offers multiple opportunities to learn and source excipient and manufacturing solutions from leading suppliers. IPEC-Americas is a vital resource for excipient manufacturers, distributors and users of excipients — pharmaceutical, biologic, animal health, combination device and healthcare product manufacturers. Through education & advocacy on the latest regulations and developments, our members support the industry’s current uses of excipients as well as the drug and biomedical technology development pipeline.

1. Fortune magazine, Startup uses A.I. to identify molecules that could fight coronavirus, by Jeremy Kahn, February 6, 2020
2. Excipient selection in biologics and vaccines formulation development, European Pharmaceutical Review, February 19, 2014
3. Drake DeOrnellis, Digital Content Specialist, On behalf of MECO