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 This requires outdated regulatory and policy restrictions to be realigned with current scientific evidence.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.

The Evolution of the Safety of Plasma Products from Pathogen Transmission—A Continuing Narrative

“…Hence, the concept of the “Tripod” of safety measures proposed conceptually by this author in 2004 [ 92 ] has been amended elegantly by Kreil to emphasise that, of the three elements of this “tripod”—donor selection, donation testing and pathogen reduction—it is the systematic inclusion of robust pathogen inactivation/removal steps in the manufacturing process which have brought the safety of plasma derivatives to its current status [ 93 ]. In the case of fresh blood components, this fundamental element of the “tripod” is still lacking in most transfusion practices.…”

Evaluation of immunoglobulin replacement therapy in secondary immunodeficiency at three British Columbia hospitals

“…In late 2018/early 2019, the FDA announced shortages of Gammagard and Cuvitru, intravenous and subcutaneous forms of Ig, respectively [16]. These shortages reflect demand outpacing supply, which was highlighted again as due to supply constraints during the SARS-CoV-2 pandemic [17,18]. This pandemic exposed the vulnerability in accessing Ig products, revealing limitations in manufacturing and source plasma collections as threats to the global supply [18,19].…”

Parameters Associated with the Required Drug Dose of Intravenous Immunoglobulin in Stable Chronic Inflammatory Demyelinating Polyradiculoneuropathy

“…The use of IVIg is increasing worldwide for all approved indications as access to IVIg becomes available in more countries and as more patients are diagnosed with rare diseases. [ 8 , 9 ]. However, IVIg is a limited resource.…”

“…Only a certain number of countries can provide the global demand. We recently experienced a supply shortage during the SARS-CoV-2 pandemic due to limitations in manufacturing and source plasma collection [ 9 ]. Local and global trade restrictions reduced the number of blood donations.…”

“…Local and global trade restrictions reduced the number of blood donations. In addition, the impact of the pandemic on pharmaceutical manufacturing and distribution affected the delivery of the final drug product to the patient [ 9 ].…”