OR WAIT null SECS
Catalent has signed an agreement with Therachon to support preclinical and clinical development of TA-46, a novel protein being developed to treat achondroplasia.
Catalent Pharma Solutions announced that it has signed an agreement with Therachon AG, a Swiss biotechnology company focused on rare genetic diseases. The contract development and manufacturing organization (CDMO) will support preclinical and clinical development of TA-46, a novel protein being developed to achondroplasia, which is the most common form of short-limbed dwarfism.
Catalent Biologics used its proprietary GPEx technology to produce different protein variants for Therachon. Multiple molecules were screened, and Therachon selected a 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.
Catalent’s proprietary GPEx technology creates stable, high-yielding mammalian cell lines with speed and efficiency. There are seven GPEx-based antibody and protein products approved and marketed to date. 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 and expected to be completed by October 2017. The facility will house two 2000-L single-use bioreactor configuration capable of producing up to 4000-L batches.