October 18-21, 2015
The implementation of single-use technologies for pharmaceutical product development continues to gain momentum; this trend is due to the advantages of increased flexibility, speed of implementation and lower capital investment In particular, they are seen as a means to accelerate the production of material for clinical trials. However, a primary concern regarding the use of such technologies is the impact leachables on patient safety in the final drug substance. Typically this concern is addressed through a patient safety evaluation utilizing extractable substances data based on model solvent extractions and from individual components and devices.
However, little if any data has been published where leachables are evaluated under actual process conditions through a complete single-use clinical-scale process train. We have addressed this by completing a pilot scale 100 L “mock” mAb production and purification where the cells, and hence mAb protein, are absent but where the bioreactor was run for the normal duration with cell culture media and feeds, and the DSP train utilized all the standard process devices, buffers, conditions, and procedures. Data will be presented on the leachables profile throughout the entire production process the result of a patient safety evaluation conducted on the bulk drug substance after storage.
Jessica Shea, Elizabeth Goodrich, Ross Acucena, Paul Killian, and Janmeet Anant, "Adopting a fully single-use process to improve speed to clinic: A leachables case study" in "Single-Use Technologies: Bridging Polymer Science to Biotechnology Applications", Ekta Mahajan, Genentech, Inc., USA Gary Lye, University College London, UK Eds, ECI Symposium Series, (2015). https://dc.engconfintl.org/biopoly/37