Plasma procurement and plasma product safety in light of the COVID-19 pandemic from the perspective of the plasma industry

Abstract

This review, written from the perspective of the plasma industry, discusses plasma procurement and plasma product safety in light of the COVID-19 pandemic. The COVID-19 pandemic impacted the whole world and, therefore, not unexpectedly, the pharmaceutical industry too. In spite of this, the plasma protein industry has continued to provide life saving therapies to critically ill patients. Moreover, companies have collected COVID convalescent plasma (CP) to support development of investigational therapies, for example, hyperimmune globulins to potentially treat SARS-CoV-2 infection, and collaborated with those collecting COVID CP for direct transfusion, which has been made available under emergency use in the United States. For plasma that is fractionated to become a therapy, general knowledge of coronaviruses and numerous new studies on the structure and function of SARS-CoV-2 provide reassurance that existing industry precautions, including donor selection, as well as virus inactivation and removal steps during the manufacturing process are sufficient to maintain the high standards of virus safety of plasma products. The pandemic also revealed the vulnerability and inadequacy of the current plasma ecosystem. There is a need for more plasma to be collected around the world to meet the growing need for safe and efficacious plasma-derived therapies. This requires outdated regulatory and policy restrictions to be realigned with current scientific evidence. More countries around the world should be in a position to contribute to global supply of plasma so that patients with life-threatening conditions - and often no alternative therapeutic solutions - have better access to care.

Keywords: COVID-19; SARS-CoV-2; pathogen safety; plasma for fractionation; plasma products.