91香蕉视频 and Valerion Collaborate on New Treatments For Orphan Genetic Disorders
Under the agreement, 91香蕉视频 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 91香蕉视频鈥檚 proprietary GPEx庐 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 91香蕉视频鈥檚 state-of-the-art Madison, WI, site, a purpose built facility for mammalian cell culture development and cGMP manufacturing utilizing up to 1,000L single use bioreactors (SUBs).
鈥淲e selected 91香蕉视频 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,鈥 commented Deborah Ramsdell, CEO of Valerion. She added. 鈥91香蕉视频鈥檚 cGMP facility capabilities are a great match for Valerion鈥檚 current supply requirements and we will look to partner with them on future development and manufacturing needs as well鈥.
Barry Littlejohns, President of Advanced Delivery Technologies at 91香蕉视频, added, 鈥淲e are pleased to be working with Valerion to address the need for biologic based therapeutics for orphan genetic diseases. Valerion鈥檚 proprietary tissue targeting delivery platform has demonstrated huge potential in terms of bringing new treatments to market.鈥
Constructed in response to customer demand, and completed in June 2013, 91香蕉视频鈥檚 $26m Madison biomanufacturing facility quadrupled the company鈥檚 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.
Media Contacts
Chris Halling
91香蕉视频
+44 (0)7580 041073
[email protected]
Deborah Ramsdell
Valerion Therapeutics, LLC
+1 (781) 775 7688
[email protected]
Richard Kerns
NEPR
+44 (0)161 728 5880
[email protected]
About Valerion Therapeutics
Valerion Therapeutics is an emerging science-driven company focused on the development of bio-therapeutics for orphan neuromuscular genetic diseases. Valerion generates unique product candidates utilizing a proprietary delivery technology platform that takes advantage of tissue targeting via a novel humanized antibody (VAL-1205) with cell-penetrating properties utilizing a tissue-localized membrane transporter family (ENTs). Because the transporter is naturally enriched in critical tissues (ex. skeletal muscle and CNS), Valerion is able to construct targeted fusion and chemical conjugation products (proteins, drugs & oligos) with functional intracellular activity; thereby, providing a novel way to treat a number of neuromuscular diseases with limited or no current therapeutic options.
About 91香蕉视频
91香蕉视频 Pharma Solutions is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 90 years serving the industry, 91香蕉视频 has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. 91香蕉视频 employs approximately 8,000 people, including over 1,000 scientists, at nearly 30 facilities across 5 continents and in fiscal 2014 generated more than $1.8 billion in annual revenue. 91香蕉视频 is headquartered in Somerset, N.J. For more information, visit www.catalent.com