Under the terms of the agreement, contract development and manufacturing organization (CDMO) Charles River Laboratories (CRL) will provide FRF with high quality plasmids produced at its Alderley Park, UK facility along with adeno-associated viral (AAV) vector materials from its Rockville, Maryland site.
Additionally, CRL will assist FRF with Phase I/II AAV vector-based gene therapy clinical trials for FOXG1 syndrome and other neurological disorders. FOXG1 syndrome is a rare genetic neurological disorder, that usually begins at infancy, often in the second month of life.
“Working with Rare & Ultra-Rare Disease Foundations, where you are so close to the patient, adds an extra sense of urgency and commitment,” a spokesperson for CRL told BioProcess Insider.
“Charles River is proud to partner with FRF and we have worked closely to tailor their program to meet project and regulatory milestones. We are proactively looking to optimize our systems to be more efficient, agile, and streamlined to reduce costs and timelines critical to patients.”
The Alderley Park facility is specifically dedicated to the manufacture of high-quality plasmid material to support Phase I/II and Tox study vector production, using CRL’s eXpDNA plasmid development and manufacturing platform.
The spokesperson said, “At the Alderley Park site we offer off-the-shelf (OTS) packaging of plasmids for AAV and lentiviral vector (LVV). These plasmids are available for immediate use and can greatly accelerate manufacturing timelines.”
Meanwhile, CRL’s Rockville facility houses the nAAVigation manufacturing platform, which will enhance the upstream and downstream manufacturing process of AAVs using its cell line and plasmid supply.
Recently, the UK-based CDMO entered into a manufacturing agreement to produce GMP-plasmid DNA for AAVantgarde’s Stargardt disease program (AAVB-039), assuring continuous supply of plasmid-DNA through its facility in Keele, UK.
In June 2024, the firm partnered with the Gates Institute based in Aurora, Colorado, to produce LVVs used in chimeric antigen receptor (CAR) T-cell therapies. Through this partnership, the institute gained access to CRL’s Lentivation LVV manufacturing platform and eXpDNA plasmid production platform.
That was followed by CRL partnering with Wheeler Bio in February 2024, to develop recombinant proteins for rapid transition of preclinical activities to first-in-human trials, under which gained access to fellow CDMO Wheeler’s Portable CMC (chemistry, manufacturing, and controls) platform, while Wheeler gained access to CRL’s RightSource insourcing solutions.
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