Plasma Technologies LLC (PlasmaTech), a plasma biologics technology company, announced that its novel human plasma fractionation process has been shown to achieve a yield of highly purified immunoglobulin G (IgG) in excess of 74% of the starting IgG content in donor plasma. This IgG yield is significantly higher than yields attainable using existing manufacturing processes that rely on older protein separation chemistries.
"We believe our highly efficient method of plasma fractionation has the potential to address the growing global IG product shortage by enabling manufacturers to capture more IgG from each precious liter of donor plasma," said PlasmaTech co-founder Dennis Curtin.
Currently estimated at $12 billion, the plasma-derived polyvalent immunoglobulin (IG) products market continues to increase at a rapid pace, resulting in a growing shortage that has prompted the U.S. Food and Drug Administration (FDA) to recently announce its commitment to "working with the industry in exploring ways to improve the manufacturing yield of IG products."1
Applying PlasmaTech's proprietary process, a separate contract biologics manufacturer has also documented final container yields of alpha-1 antitrypsin (AAT) exceeding 81% and base fractionation yields of albumin exceeding 90%. This AAT yield is approximately 600% higher than the optimal yield attained through conventional ethanol-based fractionation methods.2 A materially higher yield of albumin in the final container can also be expected using established purification methods.
"Our ongoing R&D activity has identified additional areas for further process optimization that we anticipate will further improve IgG yield," Curtin added. "Process scale-up to commercial production levels is also expected to incrementally boost yields."
In addition to producing significantly higher yields of IgG and other therapeutic plasma proteins, the PlasmaTech production process from cryopoor plasma to purified bulk formulation can be completed at bench scale in two to three days. This contrasts sharply with the 7-to-10-day production period required with current licensed manufacturing processes.3 Furthermore, the process obtained 99.7% purity of IgG. "Together with significantly improved processing yields, this extraordinarily short production cycle can potentially be transformative for the plasma fractionation industry," said Peter Radtke, PhD, a scientific advisor to PlasmaTech.
PlasmaTech's patent-protected protein separation process utilizes sodium citrate in place of the cold ethanol-based process method developed by Edwin Cohn, PhD in the early 1940s to manufacture human albumin for military battlefield use during World War II. Variants of the Cohn process still universally used today by plasma fractionators create denaturing conditions that both reduce protein yield and can adversely affect protein functionality. Substitution of alcohol with sodium citrate not only produces higher yields, but can potentially improve product purity, reduce adverse reaction rates, reduce infusion times, and provide an overall better patient experience.
"PlasmaTech's process incorporates novel and advanced fractionation and purification methods that were not available when the Cohn process was invented," said Ryan Dorfman, Vice President of Operations at Haematologic Technologies, a leading large-molecule CRO that completed much of this immunoglobulin R&D work. "The PlasmaTech process is elegant, efficient and robust."
Additional information on this novel process from Haematologic Technologies: https://www.haemtech.com/blog/resources/development-of-a-novel-plasma-fractionation-process-for-the-production-of-immune-globulin/
About polyvalent immunoglobulin products
Comprised of highly purified IgG, polyvalent immunoglobulin products are derived from donor human blood plasma and used for the treatment of primary immunodeficiency (PI) disorders, secondary immunodeficiency disorders, and a wide range of autoimmune neurological, hematologic and rheumatologic disorders, such as chronic inflammatory demyelinating neuropathy (CIDP), Guillain Barré Syndrome (GBS), multifocal motor neuropathy (MMN), Kawasaki syndrome and immune thrombocytopenic purpura.
About Plasma Technologies
Plasma Technologies LLC Is a is a privately-held research and development company focusing on plasma fractionation, which can deliver plasma derived protein therapies (e.g., immune globulin, albumin, alpha-1 antitrypsin) for a range of chronic conditions. Since inception, Plasma Technologies has been primarily focused on optimizing its sodium citrate-based fractionation and purification process to overcome the limitations of the Cohn cold ethanol process and materially increase protein yields and quality for the benefit of patients.
1 U.S. Food and Drug Administration (FDA). Information About Immune Globulin (Human) Product Shortage. August 12, 2019. Accessed 10/22/2021 at https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/information-about-immune-globulin-human-product-shortage.
2 Plasma Protein Therapeutics Association. Fact Sheets: Plasma Protein Therapy Manufacturing. Accessed 10/22/2021 at https://www.pptaglobal.org/media-and-information/fact-sheets.
3 Plasma Protein Therapeutics Association (PPTA). Plasma Derived Manufacturing. Accessed 10/22/2021 at https://www.pptaglobal.org/plasma.
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