Preclinical lentiviral vector production

As part of our scalable lentiviral vector (LVV) manufacturing platform, we offer preclinical LVV manufacturing at either a predictive 4 L scale, or at-scale 50 L and 200 L batches. To minimize timelines and risk associated with process translation into GMP, our preclinical production systems are equipped with the same upstream and downstream technologies as subsequent GMP manufacturing.

A scalable platform for the production of preclinical lentiviral vectors

We provide services for the production of LVVs from pilot scale to manufacturing scale at 4 to 200 L. Whatever scale you choose, you can rely on consistently high-quality vectors since all our bioreactor systems use the same base technologies for smooth process development and scale-up. Each preclinical manufacturing batch is accompanied by a certificate of analysis that includes sterility, titer, and other critical quality attributes, allowing the use of preclinical vectors for early safety and cell product process development efforts. 

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Lentiviral vector plasmids and cell line banking

For our LVV manufacturing services, we provide a proprietary suspension-adapted 293T packaging cell line and required helper plasmids to manufacture LVVs, and maintain master cell bank (MCB) and working cell bank (WCB) stocks of research and GMP-compliant plasmids. Regarding client-specific transfer plasmids, we can work together with you and provide MCB and bulk plasmid manufacturing services at multiple scales and grades to best support your needs. Alternatively, we can support LVV manufacturing using transfer plasmid procured through third-party manufacturers.

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Parallel cell processing to accelerate product development

For us, the development of the vector product and the cell manufacturing process are not two separate activities, where the first needs to be completed before the second can start. We can support both development paths in parallel to accelerate your timelines. Thanks to the scalability and robustness of our lentiviral manufacturing platform, we thus strive to maintain the quantity and quality of viral vectors during scale-up. Preclinical LVVs from early phases of the project are routinely used for preclinical safety and early-phase cell product process development through engineering runs.

Small-scale evaluation supports your pre-IND activities

Due to the predictive, scalable nature of our platform-based LVV process, vector material from our preclinical batches is often used by clients for IND-enabling activities, including preclinical animal studies, toxicology studies, and cell process development. Our team routinely advises on regulatory pathways to support that any pre-IND interactions with regulatory authorities align with final regulatory strategies that will be used for IND. We will consult you through any phase of your activities.

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