Collection of cellular products by apheresis with associated analytics and cryopreservation is often overlooked in the cell therapy manufacturing process. The potential for variation and lack of consistency across multiple sites can impact downstream processing and is increasingly recognised as a major driver of manufacturing complexity and failures. Having visibility and control over the apheresis “critical material” can lead to improved manufacturability of cellular products, which CTPL drives by building robust collection data sets. These data sets allow us to refine the critical quality attributes, resulting in better alignment of manufacturing processes with the diversity of apheresis products collected. Our ultimate goal is to predict the likely outcome of any collection, enabling improved patient management and earlier indicators of potential manufacturability issues.
Cell Therapies has the advantage of being located in the new VCCC building and has a close relationship with the apheresis, cryopreservation and clinical areas within the Peter MacCallum Cancer Centre. CTPL offers a range of apheresis management services including site selection, establishment and review for multi-site clinical trials, site remediation, data analysis, process development and education.
Site reviews and apheresis management support has been conducted in Japan, Europe and North America on behalf of US and European clients.