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15th August 2023  Editorial by: newprotein staff writer

Commercialization of Animal-Free Recombinant Serum Albumin

Dyadic International, Inc. have announced positive results from third-party analytical testing of the company’s animal-free recombinant serum albumin.

Using Dyadic’s proprietary filamentous fungal-based microbial protein production platforms, the company has been able to successfully develop stable cell lines to produce animal-free recombinant bovine serum albumin and recombinant human serum albumin at high levels. Initial independent analytical testing of the Company’s recombinant bovine albumin demonstrated it is structurally equivalent to commercial animal-derived product.

We are excited with the progress we are making in applying our proprietary filamentous fungal-based microbial protein production platforms in our core business units to produce proteins and enzymes for pharmaceutical and non-pharmaceutical products for ourselves and our collaborators. We are developing bovine and human animal-free serum albumin, both of which were successfully expressed efficiently with high purity. Initial third-party testing showed Dyadic’s albumin is analytically comparable to commercial reference samples which puts us closer to commercialization opportunities in the rapidly expanding global serum albumin market,” said Joe Hazelton, Chief Business Officer of Dyadic.

Mr. Hazelton continued, “With the global albumin market valued at US$ 5.7 billion in 2022 and expected to reach US$ 8.2 billion by 2028, we believe this market represents a significant growth opportunity for Dyadic. The requirement of high dosage of serum albumin in clinical applications is expected to continue to drive demand for economical large-scale production of animal-free recombinant serum albumin which provides us the opportunity to leverage our microbial expression platforms to potentially develop and commercialize multiple end-market serum albumin products in both pharmaceutical and non-pharmaceutical applications.”

Dr. Ronen Tchelet, Dyadic’s Chief Scientific Officer, said, “Dyadic offers strain engineering and production services for our customers looking to create high-performance microbial strains, C1 for biopharmaceutical applications and Dapibus™ for non-pharmaceutical applications. We believe our microbial expression platforms can speed development timelines and decrease final production costs.

Dr. Tchelet continued, “Our microbial gene expression platforms have been engineered to help address many of the common challenges of gene expression of affordable large volume protein and enzyme production at commercial scales. Positive safety readouts from our DYAI-100 Phase 1 human clinical trial and the safety and efficacy data from the non-human primate monoclonal antibody study recently submitted for publication, coupled with the relative strengths of each production host, is accelerating the interest in both our C1 and Dapibus™ technologies globally.

Serum albumin has non-pharmaceutical applications as a component of cell culture media in the alternative protein segment. Bovine serum albumin is frequently used as a component of the cell culture media to grow animal cells for the production of cultivated, or lab-grown meat. Animal-free recombinant bovine serum albumin is of particular interest to the cultivated meat sector.

Alternative proteins for food and nutrition form an important part of Dyadic's project pipeline.
  • In addition to launching a strategic partnership with a global food ingredient company, Dyadic is actively exploring licensing and product opportunities within the alternative meats industry.
  • To support commercialization efforts across the alternative protein markets, Dyadic is exploring internal and partnership opportunities for enzymes, growth factors, and cell culture media components.

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Date Published: 15th August 2023

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