In my last story, GEN spoke with bioprocessing-industry experts about advances that will impact patients. Here, other specialists discuss technology-related challenges and solutions that are underway or on the horizon.
Joanna Rucker Pezzini, president and founder of PAK BioSolutions: “One of the biggest challenges bioprocess manufacturers face is fitting new batch process into existing facility equipment. Manufacturers need to process cell-culture batches that range in titers with downstream chromatography skids, UFDF systems, and hold tanks with a limited size range. Continuous modes of operation allow a process to be scaled out by time, which reduces fit issues.”
Wolfgang Sommeregger, PhD, R&D supervisor, technologies at Bilfinger Industrietechnik: “A reduced time to market is still a priority rendering strategy for the shortening of the development phase highly valuable. Besides, the transition from batch to continuous operation introduces diverse challenges. Furthermore, to benefit from the increased availability of generated data, sophisticated techniques and trained personnel become necessary.”
Kassim Kolia, head of business development at CMO FinVector Oy: “One of the most challenging aspects for a manufacturing, science, and technology (MSAT) team in gene-therapy manufacturing is downstream processing of viral vectors. You would expect yields to decrease more than 50% for this step. New technologies come into the market trying to eliminate this aspect, but it is not a quick fix—same goes for biologics manufacture as they are similar. These approaches are satisfactory, but they are not without serious challenges.”
Gwendal Gränicher, senior scientist, USP development at Celonic: “The democratization and the use at full potential of digital solutions, such as machine learning models, to extract knowledge and to support final decisions from a broad set of data going from cell-line development to manufacturing are definitely some of today’s big challenges in bioprocessing.”