The challenges of multi-national bioprocessing operations are numerous. They include finding highly skilled experts for each site, lack of expertise with single-use systems, contamination risks and redundant efforts and resources—all of which can lead to higher costs. But these challenges also present opportunities for increasing speed to market, eliminating redundant work and overall cost savings. This white paper details the best practices used in global drug manufacturing. The key is global coordination. Best practices and specifications need to be identified…
Tuesday, December 8, 2020 Daily Archives
Analytical Ultracentrifugation for Characterization of AAV Gene Delivery Vectors
This webcast features: Christopher Sucato, PhD, Associate Director, Biophysical Characterization, and Cynthia Swanson, Associate Research Scientist, Charles River Laboratories Analytical ultracentrifugation (AUC) has been a staple in the biopharmaceutical industry to analyze aggregation and higher-order structure in protein drug products. With the recent boom in cell and gene therapies using gene-delivery vectors, new avenues for AUC-based characterization and QC lot release methodologies are now available. View this webinar for a discussion on the new parameters of AUC analysis and how…
Cell therapy process control requires a rethink, says expert
Autologous cell therapy production is a challenge and control strategies developed for protein drugs may not work, says an expert. The biopharmaceutical industry has been making therapeutic proteins for forty years. The unit operations and methods are well established and effective. Firms know how to control production to ensure the finished medicine is of appropriate quality. Industry has less experience making therapies from cells harvested from patients and this is a problem according to Rachel Yost, senior process engineer at…