Cell-based therapies are rapidly changing the way the medical industry is treating a wide range of diseases. As the development of these therapies continues to advance, effective planning and selection of appropriate source material to ensure successful manufacture of cell-based therapy, is critical.
One of the most critical first steps in the development of many cell therapies is having optimized apheresis collections. Starting with variable or low-quality apheresis presents a significant challenge to the manufacturing of these innovative products.
Despite the advances the cell therapy industry has made in recent years, commercially viable manufacturing continues to be an elusive challenge. In order for the cell therapy industry to succeed long-term, it will be crucial to migrate from a clinical-scale process in which tens to hundreds of patient doses per year are made, to a commercial-scale process that can provide thousands of patient doses per year.
We are pleased today to announce a significant upcoming transformation for our company and enhancements to our capabilities to serve our valued clients. Hitachi Chemical Co. America, Ltd. (Hitachi Chemical), our collaborator and currently minority owner of PCT, has entered into an agreement with Caladrius Biosciences, majority owner of PCT, to purchase Caladrius’ remaining share of PCT, with an expected closing of the transaction in May 2017, subject to, among other closing conditions, Caladrius shareholder approval. I have included links to the press releases by Hitachi Chemical and by Caladrius Biosciences.
Cell therapies are at the forefront of saving lives – providing critical treatments to patients who might otherwise have very few viable options. Because these therapies are so unique, there are a multitude of complex challenges that must be overcome. Of particular concern is product potency. After the manufacturing process, the shipment of the final product is crucial to ensure the patient is treated with an efficacious therapy. Without a safe delivery of incoming material, the entire manufacturing process could be compromised, resulting in a lost batch or lost time, and could ultimately lead to no final product.