As per the agreement, contract development and manufacturing organization (CDMO) CRL will manufacture the plasmid DNA required in adeno-associated virus (AAV) production for AAVantgarde. Through this partnership, AAVantgarde will access CRL’s Keele, UK, facility to assure continuous supply of plasmid-DNA.
The Keele site is a UK Medicines and Healthcare products Regulatory Agency (MHRA) licensed GMP facility that has been producing plasmid products for over 20 years. The site houses two fully segregated GMP plasmid production lines, GMP warehousing, QC testing, process development and quality assurance functions, all of which are available to AAVantgarde for the delivery of their plasmid products.
“In general terms, there is a need for rapid and reliable plasmid supply for advanced therapy applications. In response to these challenges, CRL established its eXpDNA platform to support industry leading timelines with a focus on quality,” a spokesperson for CRL told BioProcess Insider.
“Specifically, with respect to the supply of plasmids for AAV based products, CRL’s plug-and-play screening toolbox enables effective management of AAV gene of interest (GOI) transfer plasmids and the inherently unstable inverted terminal repeat (ITR) regions that are often challenging to work with but critical for successful AAV manufacture.”
Stargardt's is a hereditary muscular dystrophy and a recessive genetic disorder caused due to mutations characterized by progressive loss of central vision in children.
Clinical stage biotechnology firm AAVantgarde has two AAV-based delivery systems for efficient delivery of large genes to tissue and cells in vivo. This partnership gives CRL access to AAVantgarde’s AAV platform for the development of plasmid DNA.
“In expanding our CGT portfolio to include the contract development and manufacture of plasmid DNA, viral vectors, and cell therapies, Charles River leverages established platforms and processes to reliably support developers, such as AAVantgarde, from concept to clinic and beyond, under one roof,” the spokesperson added.
“AAVantgarde’s proprietary platforms enable delivery of large genes to tissue and cells in vivo; something that could extend into many disease areas.”
The financials of this partnership were not disclosed.
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