We supply GMP-compliant lentiviral vector (LVV) material at the scale you need without the worry of having to develop your own robust manufacturing process. With us, you have a partner with access to a ready-made GMP LVV manufacturing process platform in which raw materials, equipment, protocols, QC release assays, and much more have all been standardized and used successfully to manufacture hundreds of GMP-compliant batches of LVVs.
With our optimized protocols and GMP-compliant manufacturing process, we can rapidly transition your LVV from a research level concept into various preclinical and GMP scales of manufacturing to support your preclinical and clinical development programs. To improve product safety and reproducibility while enhancing manufacturing efficiency, our platform process is based on a chemically-defined, xeno- and serum-free suspension process. Depending on your project’s needs, the purified vector product can be filled into bags or vials.
To provide you with high quality LVVs, we have developed specifications for the GMP Master Cell Bank (MCBs), as well as for plasmids. You can either provide your own plasmid that meets all quality standards, or access our in-house plasmid production capabilities to obtain clinical-grade or full-GMP plasmid to support your LVV manufacturing needs for clinical trials.
We support internal and external QC and standard platform release testing that includes safety tests for sterility, mycoplasma, endotoxin, and vector testing. Additionally, we check all our vector products for identity, quantity, potency, and purity. If desired, we offer additional testing to meet your needs with our external QC partners.