Catalent has produced a cGMP batch of the drug to support the trial using its proprietary GPEx cell line development technology
Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, gene therapies, and consumer health products, today welcomed the news that DiaMedica Therapeutics has received US Food and Drug Administration (FDA) approval to commence Phase 2 clinical trials of its lead candidate, DM199, for chronic kidney disease (CKD). On behalf of DiaMedica, Catalent has produced a cGMP batch of the drug at its Madison, Wisconsin facility to support the trial using its proprietary GPEx cell line development technology. DiaMedica intends to initiate participant enrollment in the clinical study in the next few weeks.
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’s proprietary 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, Indiana. Both state-of-the-art facilities can 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,” commented 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.”
In addition to the proven GPEx platform, Catalent recently announced the launch of its next-generation cell line development technology, GPEx Boost. GPEx Boost enhances the existing technology through multiple improvements, including utilisation 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.
GPEx Boost has been shown to improve titers up to four-fold, potentially to 10 g/L for standard monoclonal antibodies, while maintaining the stability benefits offered by the traditional GPEx platform. In addition, benefits have been observed in cell growth and viability. Developmental timelines for projects can be shortened and made more efficient by combining this new platform with the rapid screening capabilities of Berkeley Lights’ Beacon optofluidic platform, and ambr automated micro bioreactors. The first customer has already signed up to leverage the technology for a Fc-fusion protein.