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 U.S. 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.
SOMERSET, N.J. (PRWEB) JANUARY 23, 2020
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 U.S. 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.
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 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.
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.
For further information visit biologics.catalent.com.
About Catalent Biologics
For more than two decades, Catalent Biologics has built capabilities and experience in development, manufacturing, and analytical services for new biological entities, gene therapies, biosimilars, and antibody-drug conjugates. Catalent has worked with 600+ mAbs and 80+ proteins, and to date, 12 biopharmaceutical drugs produced using GPEx® cell line development technology have been approved and marketed, with more than 120 ongoing clinical trials utilizing therapeutic candidates developed using the GPEx® platform. A further 25 commercially-approved products have employed Catalent Biologics’ capabilities through to aseptic fill/finish. Catalent’s latest addition, Paragon Gene Therapy, provides industry-leading capabilities and expertise in the development and manufacturing of adeno-associated virus (AAV) vectors, next-generation vaccines and oncolytic virus production. Its manufacturing facilities in Baltimore, Maryland have produced over 100 GMP batches across 40 clinical and commercial programs. Using advanced technology and tailored solutions for clinical through commercial supply, Catalent Biologics brings better biologic treatments to patients, faster.
About Catalent
Catalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, gene therapies, and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent employs over 13,000 people, including approximately 2,400 scientists and technicians, at more than 35 facilities, and in fiscal year 2019 generated over $2.5 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit http://www.catalent.com.
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About DiaMedica Therapeutics, Inc.
DiaMedica Therapeutics, Inc. is a clinical stage biopharmaceutical company focused on developing novel treatments for chronic kidney diseases and neurological disorders. DiaMedica’s shares are listed on The Nasdaq Capital Market under the trading symbol “DMAC.”
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.
