Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, 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, USA), biomanufacturing facility.
“The work being done 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 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 under way, which will house a two 2000 L single-use bioreactor configuration capable of producing 2000 or 4000 L batches, and will be completed by October 2017.