Wednesday November 09, 2022 from 08:30 to 10:00
Implementing X-ray for single use bioprocess systems sterilization: challenges and successful industry alignment
Samuel Dorey1, Mélanie Gauthier1, Isabelle Gay1, Nina Perier1, Nathalie Dupuy2, Sylvain R.A. Marque3.
1Product Development, Sartorius, Aubagne, France; 2CNRS, IRD, IMBE, Aix Marseille Université, Marseille, France; 3CNRS, ICR, case 551, Aix Marseille Université, Marseille, France
The single-use disposable technologies for biopharmaceutical manufacturing combine single-use holistic processes and facility strategy to overcome scale limitations and enable cost-efficient manufacturing to support the growing demand for many biologics. This industry is facing unprecedented challenges with irradiation sterilization capacity resulting in assessing X-rays as a suitable and equivalent alternative to gamma. It will thus reflect on post-pandemic world solutions to build capacity with high flexibility, while looking forward to anticipating future increase in sterilization demand. Unfortunately, these radiation processing also present disadvantages of inducing modifications for exposed materials. The question of a comparative study between the effects of different types of radiation and their impact on the materials/products studied arises. This current lack of data represents a hurdle for biopharmaceutical manufacturers desiring to transition from gamma-ray sterilization modalities to X-ray or electron-beam. The Bioprocess Systems Alliance (BPSA) thus published a consensus risk-based qualification approach to assess the impact of X-ray vs gamma. The Team Nablo project also proposed a holistic research approach covering several disciplines. To achieve its goals, the team has integrated technological, academic, and industrial research at several levels (molecular, macromolecular, and materials levels) and has worked in conditions that are as close as possible to those found in industry. In an effort to help fill these data gaps previously enounced, assessment approaches will be enounced and different results will be shown on products including their polymer components previously irradiated by the different irradiation modalities (gamma and X-ray).