Family-owned contract development and manufacturing organization (CDMO) Rentschler has installed a lentiviral vector (LVV) manufacturing toolbox at its Stevenage, UK, facility.
According to the Germany-based firm, the LVV toolbox is a comprehensive suite of tools and services designed to facilitate the development and production of lentiviral vectors for cell and gene therapy (CGT) applications.
“We are fortunate to have a highly skilled team with an extensive lentivirus production expertise who were able to develop a process that fits into our facility,” a spokesperson for Rentschler told BioProcess Insider. “For process optimization, we had to develop efficient upstream and downstream processes that would allow us to maximize yield. For purity scalability, we had to ensure that production methods could be scaled up without compromising quality.”
“We operate a single-use facility that ensures product containment from batch to batch. We offer a full suite of quality control (QC) services – including drug-substance and drug-product release and stability studies – to ensure the vector produced is suitable for use in clinical or commercial settings.”
The CDMO established manufacturing capabilities at the UK CGT Catapult facility, launching itself into the regenerative medicine space in 2021. The Stevenage site is dedicated to advanced therapy programs and providing process and analytical development in addition to GMP-manufacturing services for the clinical and commercial supply of viral vectors.
“All the LVVs manufactured will be extensively characterized to ensure their potency and quality is maintained. The efficacy of a lentivirus product is linked to the gene of interest and its therapeutic use as defined by the client. All released viruses for therapeutic use would need to meet requirements for infectivity, and thus be used in clinical trials designed by the client to assess efficacy,” the spokesperson added.
Rentschler will use the toolbox to generate a unique royalty-free process for its clients, with a flexible approach that can include direct application of the toolbox process. Additionally, the clients can opt for analytic development prior to transfer to cGMP manufacturing and QC release, the firm confirmed.
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