Contract development and manufacturing organisation (CDMO) Andelyn Biosciences has entered a collaboration with Amplo Biotechnology to manufacture adeno-associated virus (AAV) gene therapies to address conditions affecting the neuromuscular junction (NMJ).
The collaboration aims to facilitate the scaleable production of clinical-grade AAV material, utilising Andelyn’s suspension AAV Curator platform.
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The platform employs a data-driven methodology to refine and enhance customer processes, paving the way for current good manufacturing practice (cGMP) and commercial production.
Amplo will leverage this platform to progress its AAV gene therapy initiatives towards clinical assessment, concentrating on the efficacy and safety essential for forthcoming studies.
Andelyn Biosciences chief commercial officer Matt Niloff stated: “As a leading clinical and commercial CDMO, we are honoured to support Amplo Biotechnology’s efforts to bring hope to patients affected by debilitating NMJ diseases.
“Our Curator platform and end-to-end capabilities are designed to help partners achieve key development and clinical milestones.”
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By GlobalDataNMJ diseases often lead to muscle weakness, with severe instances necessitating respiratory support, wheelchair use or tube feeding.
These disorders can be life-threatening and are usually diagnosed in early childhood, although they may also present during adolescence or adulthood.
Based in the US state of Idaho, Andelyn is focused on characterising, developing and producing viral vectors for gene therapy.
Amplo’s primary programme, AMP-101, is progressing towards a first-in-human study for Dok7 congenital myasthenic syndrome, based on research conducted at the universities of Tokyo and Oxford.
Amplo previously secured a fast-track phase I/II STTR grant from the National Institutes of Health’s National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIH-NIAMS) for its gene therapy AMP-201.
Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.
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