BioLife Plasma Services, part of Takeda, has implemented a unique protocol for collecting plasma from healthy individuals who have recovered from COVID-19 to enable development of a potential therapy for COVID-19, made from human plasma.
This development program will be conducted by Takeda, together with other leading plasma companies, as part of the CoVIg-19 Plasma Alliance. Those who have fully recovered from COVID-19 and are no longer contagious are encouraged to donate plasma to help support the development of a potential treatment for individuals for whom COVID-19 presents significant risk, known as CoVIg-19.
“Convalescent plasma refers to the plasma of individuals who have successfully recovered from an infection and have developed an immunity – or antibodies – against the pathogen that caused the disease,” explained Julia Ellwanger, Senior Communications Lead, Plasma-Derived Therapies. “The immunity is the basis for developing a therapy that, when administered to high risk individuals, may help their immune system respond to the infection and increase their chance of recovery. Healthy individuals who have not been exposed to COVID-19 do not have this immunity.”
CoVIg-19 is a hyperimmune globulin (H-IG) compound similar to intravenous immunoglobulin (IVIG) except that it is prepared from the pooled plasma of donors with high titers of antibody against a specific organism or antigen.
Use of a hyperimmune globulin therapy means a higher concentration of antibodies can be administered with lower volumes, therefore administration of the treatment to a high-risk individual would likely take less time than if they were to receive plasma directly. Furthermore, the risk of transmission of any kind of known virus from the donor to the recipient is mitigated through the virus inactivation and removal steps incorporated into the plasma product manufacturing process.
“H-IG therapies have been found to be effective in the treatment of severe acute respiratory infections of viral etiology,” said Ellwanger. “In fact, in response to the 2009 H1N1 influenza pandemic, Takeda successfully produced a hyperimmune globulin to address a pandemic virus.”
All BioLife centers have the capability to collect plasma from individuals who have fully recovered from COVID-19.
“Our first step is to connect with individuals who may fit the criteria for donation of convalescent plasma,” said Ellwanger. “We encourage individuals who fit the criteria for officially confirmed diagnosis and subsequent recovery from COVID-19 (with the appropriate documentation from their physician), to please contact our MedInfo Center at 1-877-TAKEDA-7 (1-877-825-3327).”
If individuals do not reside near an existing BioLife center, they can visit this link to find the nearest licensed plasma collection center to their location.
“Plasma collection is a critical service, as the plasma we collect is used to produce life-saving and life-sustaining plasma-derived therapies that thousands of people with rare, chronic and complex diseases rely on every day, many of whom have few alternative options,” said Ellwanger. “Many of these patients have compromised immune systems, making them especially vulnerable to infection, so it is vital they have continuity of care.”
Because of the essential services BioLife provides through plasma donation, plasma collection has been explicitly noted in the U.S. Dept of Homeland Security criteria as a critical service and has a special responsibility to remain open. (See latest guidance here)
Ellwanger added that BioLife has seen a moderate decline in donation rates, which may be directly related to concerns about the SARS-CoV-2 virus.
“We continue to encourage healthy individuals to consider donating plasma to support our efforts to provide an uninterrupted supply of plasma-derived medicines,” she said. “We encourage and welcome all awareness and educational initiatives that will help ensure patients who rely on plasma-derived therapies continue to have care long-term.”
To maintain their own commitment to patients, BioLife is taking a number of extra precautionary measures to protect employees and those who choose donate, including extra cleaning processes, social distancing practices and associated training.
“Our standard strict donor selection criteria to ensure the good health of prospective donors have been expanded to exclude criteria related to COVID-19, and our protocol now requires that all donors are checked for fever when they arrive and undergo basic screening to limit infectious diseases, including this virus, as much as possible,” said Ellwanger. “Similarly, our employees have temperature screening before they begin work, and if they feel they may pose a risk, we ask them to remain home.”
For additional information pertaining to the safety of plasma and plasma donation, please see information from the Plasma Protein Therapeutics Association. The PPTA has released an updated statement for donors or those interested in donating – read it here.