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.
Insilico Medicine, a startup based in Rockville, Md., says it has used artificial intelligence to rapidly identify molecules that could form the basis of an effective treatment against the coronavirus at the heart of the current outbreak.
It took Insilico’s A.I.-based system four days to identify thousands of new molecules that could be turned into potential medicines against the virus. Insilico says it will synthesize and test 100 of the most promising candidates, while publishing the full library of new molecular structures it has generated for other researchers to possibly use.
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 Gilead struck a deal earlier this week with a Beijing hospital 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 products2
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
Photo credit: Government of Prince Edward Island