Balancing the combined risks of a non-linear therapy development pathway, funding limitations, clinical trial milestones and scarcity of skilled personnel requires the right amount of attention to commercial manufacturing considerations. During the strategic planning and feasibility stage of our process, we will define a detailed and achievable manufacturing establishment roadmap to support your commercialization plan. This provides a viable concept of how the product will be manufactured at commercial-scale and the path to reaching that point. This demonstrable path to commercial production becomes a valuable fundraising tool, driving structured investment aligned with the progression of clinical manufacturing needs.

Commercial supply of cell and advanced therapies requires consistent product quality. That typically means a considered transition from open, manual processing to closed, automated production. Beginning with a deep understanding of our client’s process, we take a carefully structured approach to demonstrating  performance  capability for each unit operation before combining proven elements to configure a manufacturing solution meeting process needs. The elimination of variability in a mature process drives consistent product quality through the removal of skill-based operations and advanced, repeatable control over all process variables. 

Beyond efficacy, therapy production cost becomes the major driver of commercial success—perhaps more than any previous field of medicine. The right solution is rarely to automate everything. Our ‘whole-of-system’ approach typically combines our configurable modules, the best existing technologies on the market, our global network of leading partner organizations, and our powerful ability to produce tailored/custom solutions where gaps exist. Our ability to integrate the best of each aspect delivers scalable, cost-effective therapy manufacturing.