At PCT we constantly think beyond current cell therapy manufacturing practices to help clients and the industry develop approaches that address the core challenges presented by cell-based therapies.
We leverage a Development by Design (DbD) approach to manufacturing that takes into account a product’s quality, cost of goods, process scalability and sustainability, the critical drivers of successful commercial manufacturing. We have also encountered first-hand—and analyzed case studies from—the industry’s experience with commercialization to date and determined that in order for cell therapies to be cost-effective, robust, scalable and sustainable, process innovation must be considered early on in the path from preclinical development to commercialization.
Meet Our Experts
Brian Hampson, M.E., Vice President, Global Manufacturing Sciences and Technology &
M.E., Electrical, Cornell University, NY
Brian, leader of PCT’s Manufacturing Sciences and Technology (MSAT) team, has focused his career on development of first generation products and manufacturing processes for medical and biotechnology markets. He brings to PCT an extensive background and broad knowledge of many technical disciplines, including control systems, process automation, software, fluid systems, cell culture processes, aseptic/closed-system processing, and single-use disposable systems.
To succeed as an industry, manufacturers of cell therapies must be able to produce a high-quality product at a reasonable cost of goods that meets demand over the commercial life of the product. At our Center for Innovation and Engineering, we assess clients and develop processes, technologies and automation, providing them with a robust strategy to lower the cost of goods and enable robust scale up of therapeutics.
Through our Center for Innovation and Engineering we have developed partnerships with industry leaders in instrumentation to allow PCT early access to beneficial technologies and to engineer new solutions to advance the industry.
Our team of experienced cell therapy specialists work closely with our clients to provide comprehensive scientific, technical and regulatory support through the entire lifecycle of cell therapy development. We bring to our consultations more than 16 years of actual process development and manufacturing experience in a current Good Manufacturing Process (cGMP)-regulated environment, and a history of helping clients reach strategic clinical and commercialization milestones for their product.
Defining your product and planning for commercial manufacturing early in clinical development can facilitate steady progress toward the bedside and position a therapeutic to deliver the desired benefit for the target patient population. To achieve this, PCT applies a Development by Design approach.