CDMO Fujifilm Diosynth Biotechnologies (FDB) says partnering with OXGENE could reduce the lead time of its customers’ gene therapy projects by up to 25%.
The technology, licensed from UK-based OXGENE for an undisclosed fee, consists of Helper, Rep/Cap and Gene of Interest plasmids, used in combination with a clonal suspension a HEK293 cell line.
The AAV system is expected to reduce the length of the supply chain gene therapy customers, according to contract development and manufacturing organization (CDMO) FDB, with the standard lead-time from the start of process development to the first GMP manufacture potentially reduced by three to six months.
FDB will manufacture and stock a supply of Helper and Rep /Cap plasmids for clients engaged in process development and GMP manufacture of gene therapy programs. Gene of Interest (GOI) plasmid manufacture will be performed in-house using FDB’s existing microbial capabilities and facilities at its site in College Station, Texas with cGMP manufacture planned to commence in Q4 2020.
The site is subject to numerous investments by the CDMO, the latest a $35 million expansion adding cell culture and high throughput manufacturing suites.
“OXGENE’s AAV system is superior to off-the-shelf plasmid systems for AAV titers,” said Andy Topping, chief scientific officer at FDB, adding the agreement gives the CDMO ‘plasmid to drug product’ capability for AAV systems “and allows clients to avoid delays associated with GMP production of plasmids.”
UK-based OXGENE was founded as a plasmid catalog business eight years ago. Sophie Lutter, scientific marketing and communications manager, told this publication how the firm’s technology works at the Phacilitate conference in January.
“We start with custom plasmid design and engineering — we have plasmid sets optimized for AAV and lentiviral production — and then we pair that with our GMP-banked clonal suspension HEK293 cell lines and engineered derivatives,” she explained. “We take them through to process development, where we can support scales of up to 10 L.”
With downstream purification as part of its platform, the company offers a full viral-vector package. “This leaves the customer not only with the final viral vector, but also [with] the processes and protocols to take that through to GMP manufacture.”