Catalent Pharma Solutions 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 protein addressing achondroplasia, which is the most common form of short-limbed dwarfism.

Under the agreement, Catalent Biologics has employed its proprietary GPEx technology, which produces mammalian cell lines, to produce different protein variants for Therachon, to allow it to screen multiple molecules and subsequently select its 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.

To date, Catalent has had  with its partners seven GPEx-based antibody and protein products approved and marketed, and more than 40 therapeutic candidates are currently in the clinic, Catalent’s facility in Madison, Wisconsin provides cell-line development, process development, and analytical and manufacturing services using 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.

Source: Catalent Pharma Solutions