Akron Biotechnology (Akron Biotech) has signed an exclusive global agreement with Swiss-based Octapharma, to manufacture virally inactivated Human AB Serum for the cell therapy market.
Akron Biotech will produce the Human AB Serum using Octapharma’s solvent-detergent treated human plasma, Octaplas.
The Octaplas viral inactivation and production process includes several independent and complementary steps to eliminate or reduce non-enveloped and enveloped viruses such as the novel SARS-CoV-2, the viral agent causing COVID-19. After being co-labeled, the product will be sold across the US, EU and Asia.
Human AB Serum converted from plasma is considered to be an important media supplement used in cell therapy manufacture.
At a time when the world is facing the Covid-19 pandemic, patient safety takes the highest priority.
The use of virally inactivated, licensed pharmaceutical grade plasma product such as Octaplas can support the needs of research and development with a view to commercialisation.
Akron Biotech president and chief commercial officer David Smith said: “After years of working with Octapharma, we are taking our relationship to the next level to create a powerful resource for the cell therapy market.
“The products that result from Octapharma’s plasma technologies and Akron Biotech’s manufacturing and commercialisation will enable the global industry to move forward with greater confidence and safety.”
As per most regulatory agencies around the world, the highest quality raw and ancillary materials should be used for manufacturing cell therapies, and such materials should be thoroughly assessed and qualified through a comprehensive, risk-based approach.
Virally inactivated Human AB Serum promises to reduce the risk of one of the more complex ancillary materials common in cell therapy manufacturing significantly.
Octapharma USA president and Octapharma Group board member Flemming Nielsen said: “Octapharma is proud to support the growing cell and gene therapy market with Octaplas converted materials. Octaplas is manufactured with batch to batch consistency of plasma proteins and carries the added benefit of being virally inactivated with FDA approval (for intravenous infusion).
“With the continued advance of clinical and commercial cell therapies, it is increasingly important that the materials used are of the highest quality and safety standards available. This partnership coupled with Akron Biotech’s investment in state-of-the-art manufacturing facilities will be essential to support this growing market.”