Phase II

Traditional vector manufacturing results in a new batch of packaging cells with every run. Polyclonal processes like these are difficult to control and have wide fluctuations in yield and quality even within a given scale.

Using your vector backbone and accessory genes, iVexSol will create a project-specific, clinical-grade master cell bank of producer cells engineered to generate optimized vector for your unique process. This bank of monoclonal producer cells will create a final vector preparation of predictable quality with minimal batch-to-batch variability. This will minimize your CMC burden and greatly reduce your need for comparability studies saving you time and money.

Clinical Lentiviral vector manufacturing campaigns often take 12-18 months to secure and execute. Programs at this stage of development are often attempting to increase their production scale, requiring new rounds of process development. These large-scale development runs are costly in terms of time and money, frequently resulting in stalled programs and missed milestones.

Our ability to generate master cell banks of stable vector-producing cells transforms production by enabling Vector on Demand ^TM. Rather than restarting a highly variable and risky process from scratch each time you need more vector, we simply expand a vial from your bank, harvest and cryopreserve the precise amount of vector you require, and ship it to you (or anywhere else in the world) ready to use within weeks, not months, of your order.

As vector production volumes increase, so does cost of goods, capital costs, overhead, and batch failure rates. Increasing scale and aligning manufacturing with increasing quality demands such as removing serum or changing from adherent to suspension production commonly results in altered product potency. This variability increases CMC and analytical filing demands. Resulting in a significant amount of the batch being used to support QA/QC regulatory testing requirements rather than the manufacture of patient doses. This, in turn, requires the production of yet more batches to ensure supply and yet more CMC burden to prove comparability.

iVexSol’s uses an optimized monoclonal master cell bank to initiate every production run which can be expanded to any scale without changes in product quality. As opposed to traditional manufacturing, iVexSol’s Intelligent Manufacturing allows for rapid progression from small to ultra-scale batches which allow you to treat more patients with the same batch reducing clinical variability, CMC burden, and timeline delays.