Catalent Pharma Solutions today announced that it is to collaborate with Valerion Therapeutics, to develop Valerion’s two lead product candidates. The collaboration will focus on the delivery of muscle-protein fusions, and treatment of multiple indications, in the fields of muscular dystrophies, glycogen storage diseases, myopathies and enzyme-deficiency disorders.
Under the agreement, Catalent will provide all cell line engineering, process development and cGMP biomanufacturing activities associated with the two lead products, which utilize a novel antibody-based targeting system, capable of enhanced intracellular delivery of functional proteins, oligonucleotides and small molecules. The project will utilize Catalent’s proprietary GPEx® technology, which creates high-expression, extremely stable mammalian cell lines with speed and efficiency, typically capable of getting drug development projects to clinic in one-third the time of traditional approaches. The advantages of applying GPEx technology span from early feasibility studies, to clinical manufacturing, to commercial scale production.
Should initial studies prove successful, the therapies will be produced at Catalent’s state-of-the-art Madison, WI, site, a purpose built facility for mammalian cell culture development and cGMP manufacturing utilizing up to 1000L single use bioreactors (SUBs).
“We selected Catalent as our development and manufacturing partner for this exciting project as the company has both the expertise and proprietary technologies required to bring these candidates to the clinic in the shortest possible timeframe,” commented Deborah Ramsdell, CEO of Valerion. She added. “Catalent’s cGMP facility capabilities are a great match for Valerion’s current supply requirements and we will look to partner with them on future development and manufacturing needs as well”.
Barry Littlejohns, President of Advanced Delivery Technologies at Catalent, added, “We are pleased to be working with Valerion to address the need for biologic based therapeutics for orphan genetic diseases. Valerion’s proprietary tissue targeting delivery platform has demonstrated huge potential in terms of bringing new treatments to market.”
Constructed in response to customer demand, and completed in June 2013, Catalent’s $26m Madison biomanufacturing facility quadrupled the company’s biologics manufacturing capacity. Designed for flexible cGMP production from 10L up to 1,000L, and non-GMP production up to 250L, the site features single-use technologies and unidirectional flow to maximize efficiency and safety.
