Control of apheresis collections can lead to improved manufacturability of cellular products
The management of clinical apheresis collections is critical to the success of many cell and gene therapy product candidates being developed today. Apheresis product is the most critical starting material in many of these manufacturing processes, with relatively few controls in place to ensure consistency and downstream manufacturability.
Additional variability is introduced if multiple apheresis collection sites are used in a clinical trial, which is inevitable for commercial products. Cell Therapies can provide a scalable solution to provide control over this critical starting material.
We have over 12 years’ experience managing apheresis collections under GMP quality oversight to meet Australian regulatory standards. As such, we have developed the clinical protocols, process controls, documentation and training, and quality systems to ensure collections at Peter Mac meet all regulatory expectations during inspection. We can provide unique expertise that can be translated to worldwide programs, which has already been utilised for global clinical trials.
Our approach is captured in 5 different modules, which can be implemented collectively or separately depending on the current needs of your program:
An optimised apheresis management system has significant short- and long-term benefits, including improved conversion of patient collections into manufactured product, increased clinical trial recruitment, and building towards commercial deployment. Our apheresis management service can be the difference to make your clinical or commercial program a success.
Please contact us today to get started.