Catalent Pharma Solutions today announced that it has signed an agreement with Therachon AG to support preclinical and clinical development of TA-46, which is the most common form of short-limbed dwarfism
Somerset, N.J. – May 15, 2017 — Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, today announced that it has signed an agreement with Therachon AG, a Swiss biotechnology company focused on rare genetic diseases, to support preclinical and clinical development of TA-46, a novel protein addressing achondroplasia, which is the most common form of short-limbed dwarfism.
Under the agreement, Catalent Biologics has employed its proprietary GPEx®
technology to produce different protein variants for Therachon, allowing them to screen multiple molecules and subsequently select their clinical candidate for further development.
Catalent has been working with Therachon for more than a year to support the selection of the clinical candidate, and will now go on to manufacture cGMP material for a Phase I clinical study, scheduled for 2018. The project will be conducted at Catalent’s Madison, Wisconsin, biomanufacturing facility.
“The work being carried out by Therachon’s team is truly innovative and could have a significant impact for those diagnosed with achondroplasia and suffering the associated complications,” commented Mike Riley, Vice President and General Manager of Catalent Biologics. “The development work undertaken by Catalent Biologics to support Therachon’s outstanding research has the potential to bring this potentially life-changing product to the market as quickly as possible."
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. To date, seven GPEx-based antibody and protein products are approved and marketed, and more than 40 therapeutic candidates are currently in the clinic across the world. Catalent’s facility in Madison, Wisconsin provides a full range of cell line development, process development, analytical and manufacturing services leveraging single use bioreactor systems. An expansion of the facility is underway, which will house a two 2,000 liter single use bioreactor configuration capable of producing 2,000 liter or 4,000 liter batches, and will be completed by October 2017.
For more information on Catalent Biologics, visit www.CatalentBiologics.com
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Notes for Editors
About Therachon AG
Therachon is a global biotechnology company focused on developing medicines for rare, genetic diseases that currently have no available treatments. The company’s lead pipeline candidate, TA-46, is a novel protein therapy in development for achondroplasia, the most common form of short-limbed dwarfism. This rare genetic condition affects about one in 25,000 children and is caused by a genetic mutation of the FGFR3 receptor, which stunts child bone growth. Therachon is committed to translating the promise of its science into new treatments for patients with high unmet medical needs. For more information, visit www.therachon.com. Follow Therachon on Twitter and LinkedIn.
About GPEx® technology
Catalent performs GPEx programs at its commercial biomanufacturing facility in Madison, Wisconsin. Designed for flexible cGMP production from 10 L up to 1,000 liters, and non-GMP production up to 250 liters, the site features extensive single-use technologies and unidirectional flow to maximize efficiency and safety. Catalent recently announced the commencement of work to extend its Madison facility and add 22,000 square feet of space.
Catalent is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 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 approximately 10,000 people, including over 1,400 scientists, at more than 30 facilities across five continents, and in fiscal 2016 generated $1.85 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit www.catalent.com