Laureate Biopharma is pleased to announce its successful collaboration with Dyax Corp. for process development and cGMP production of a new treatment candidate for hereditary angioedema (HAE). The drug candidate, known as DX-2930, is a fully human IgG antibody designed to prevent HAE attacks by inhibition of plasma kallikrein. Dyax, a biopharmaceutical company focused on HAE and other plasma kallikrein disorders, recently announced the start of a Phase 1 clinical trial evaluating the safety and tolerability of DX-2930.
In working with the cell line producing DX-2930, Laureate's scientists were able to successfully scale-up and manufacture a high-titer antibody process. This process was amendable to cGMP production in both stainless-steel and single-use bioreactors. Application of Laureate's platform downstream process for IgG antibodies led to high protein recovery and purity. Aseptic filling, a routine operation at Laureate, produced the clinical drug product in 98% yield. Finally, careful project management of the program by both companies resulted in the successful release of bulk drug substance.
"Entry into human subjects is an important milestone for the DX-2930 development program," said Gustav Christensen, President and CEO of Dyax. "It was a pleasure to work with Laureate's scientific and program management team. This valuable partnership has enabled us to advance this fully human monoclonal antibody into the clinic and closer toward our goal of a new therapeutic for the prevention of HAE attacks."
"This project showcased Laureate's scientific expertise in rapid development of efficient, high-yielding processes for clinical production of therapeutic antibodies," noted Michiel E. Ultee, Ph.D., Laureate's Chief Scientific Officer. "Our scientists have produced a wide variety of antibodies for more than 30 years, including IgG, IgM, fragmented (Fab & F(ab')2), conjugated, aglycosylated and domain-deleted antibodies."
SOURCE Laureate Biopharma