Blog | HemaCare

“As the industry and regulatory landscape continues to evolve, it’s vital that as an industry, we take a lifecycle approach to risk management –to ensure that we mitigate as much risk as possible all the way from discovery through to commercialization.” - Dr. Dominic Clarke, Global Head of Cell Therapy, HemaCare

Cell and Gene Therapy Insights has just published HemaCare’s white paper on how to manage starting material quality and stability to maximum effect during cell therapy manufacturing. ^[1] Quality cell therapies can only be created from quality starting materials, yet paradoxically, starting materials are the single greatest source of variability in the cell therapy manufacturing process. Mitigating risk requires minimizing that variability, and also managing shelf-life limitations and biopreservation logistics.

Last week, HemaCare published an article in Technology Networks discussing how optimal apheresis and collection methods give cell therapies a leading edge¹ 

Cell therapy is a unique field because the “products” are derived from living human cells and where each donor is different, variability is inevitable. Quality precursor material gives cell therapy products their best start. Variable or low-quality starting material introduces a need for complex separation strategies or repeated manufacturing runs, leading to higher costs and resource requirements.¹ To ensure the process utilizes the right resources, scientists must adopt optimal apheresis instrumentation and collection methods as one of the most important steps. 

Mesenchymal stem cells (MSCs) are a type of adult stem cell that can be isolated from the bone marrow, peripheral blood, fallopian tube, and abdominal adipose tissue. Mesenchymal stem cells have been shown to generate multiple cell types, such as bone, cartilage, muscle, cardiomyoctes, endothelial cells and neurons. Because of its high capacity for self renewal and multipotency, MSCs provide enormous therapeutic potential for cell therapy. To use stem cells in the clinic for disease treatment, the manufacturing process has to be standardized to ensure that the final products are safe and efficient.