Bedford, Mass., March 29, 2022 (GLOBE NEWSWIRE) — The Bill & Melinda Gates Foundation has given a grant to Conagen to support further development of its Conamax(TM) platform for the production of accessible low–cost and high–quality monoclonal antibodies, benefitting developing countries and patients globally.
The high cost of monoclonal antibody (mAb) production makes blockbuster drugs expensive, limiting the markets in which these molecules can be applied and limiting access to large patient populations in developing and industrialized countries. The reason for high production costs is, in part, intrinsic to the use of mammalian cell expression systems for antibody manufacturing.
"The Conamax platform was originally conceived to address this global unmet need, so we are thrilled to have the support of the Bill & Melinda Gates Foundation to help develop affordable antibody therapeutics," said Casey Lippmeier, Ph.D., vice president of innovation at Conagen.
With rapid cell growth, human–compatible glycan structures, and demonstrated world–scale fermentation bioprocesses, the Conamax platform holds several advantages over Chinese Hamster Ovary (CHO) cell lines and other mammalian expression systems, as well as other microbial platforms.
The foundation grant funds the bench–scale development of a proof–of–concept study of a continuous purification process, customized to inputs from Conamax and potentially other microbial host organisms. With large–scale advancements, Conagen envisions that this process will be capable of continuously purifying mAbs from material generated in bioreactors with volumes greater than 250,000 liters.
As a significant advantage, the process will not require expensive binding proteins or other expensive column purification steps. This process will enable economies of scale which are not accessible to CHO or other mammalian–derived cell systems while also providing rapid, high–throughput purification of large amounts of antibody.
"Incumbent antibody manufacturing and purification processes based on Chinese Hamster Ovary (CHO) cell lines have brought tremendous advancements to biopharmaceuticals,” said Lippmeier. “However, CHO cell systems are comparatively low volume, expensive, and do not enable low cost and efficient purification of large amounts of antibodies."
According to McKinsey, in 2019, global sales revenue for all mAb drugs was nearly $163 billion, representing about 70% of the total sales for all biopharmaceutical products, approximately $230 billion. That is about a 50% growth in sales and proportion since 2013, when it was $75 billion.
Continued growth in sales of currently approved mAb products, along with more than 1,200 mAb product candidates currently in development "" many for multiple indications "" will continue to drive the overall sales of all biopharmaceutical products.
"We're unlocking the way to make drugs more affordable and, while doing so, opening additional markets for biologics," said Lippmeier.
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About Conagen
Conagen is a product–focused synthetic biology R&D company with large–scale manufacturing service capabilities. Our scientists and engineers use the latest synthetic biology tools to develop high–quality, sustainable, nature–based products by precision fermentation and enzymatic bioconversion. We focus on the bioproduction of high–value ingredients for food, nutrition, flavors and fragrances, pharmaceutical, and renewable materials industries. www.conagen.com
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