Catalent Biologics Collaborates with Therachon to Develop Novel Protein Therapy for Achondroplasia

May 15, 2017
BioPharm International Editors

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.

Source: Catalent