DiaMedica Therapeutics has received U.S. FDA approval to begin Phase II trials of its lead candidate, DM199, for chronic kidney disease (CKD). Catalent has produced a cGMP batch of the drug for DiaMedica at Catalent’s Madison, WI facility to support the trial using its GPEx cell line development technology. DiaMedica intends to initiate enrollment in the study in the next few weeks.

Catalent’s GPEx technology creates stable, high-yielding mammalian cell lines with high speed and efficiency. The advantages of applying GPEx technology span from early feasibility studies to clinical manufacturing, through to commercial-scale production. Twelve biopharmaceutical drugs have been approved using Catalent Biologics’ GPEx technology, with more than 120 additional therapeutic candidates in ongoing clinical trials. In addition to Madison, the Catalent Biologics network also includes a second drug substance development and manufacturing site in Bloomington, IN. Both facilities provide clinical and commercial manufacturing for GPEx and non-GPEx cell lines. The Bloomington facility and the company’s European sites in Brussels, Belgium and Anagni, Italy also provide clinical and commercial drug product manufacturing for biologics.

“GPEx technology has been shown to be particularly suited to the development of a high-expressing cell line for this difficult-to-express protein, compared to other approaches that DiaMedica had tried previously,” said Michael Riley, Region president, Biologics North America. “We look forward to working with DiaMedica on this exciting and important candidate, as well as potentially others in DiaMedica’s future development pipeline.”

Catalent also recently launched its next-gen cell line development technology, GPEx Boost, which is designed to enhance the existing technology with improvements, including utilization of a glutamine synthase (GS) knock-out Chinese hamster ovary (CHO) cell line. The combination of technology and platform enhancements has resulted in improved ability of cells to produce high titers and increase specific productivities of a protein of interest.