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In this episode of Drug Digest, Pharmaceutical Technology editors discuss the advantages and savings that continuous manufacturing may offer as well as the very real obstacles that might make a fully continuous process not feasible, especially in biologics manufacturing.
The bio/pharma industry is building on the small successes of continuous manufacturing (CM) for the advanced manufacture of bio/pharmaceuticals. With FDA throwing its support behind CM as part of a bigger initiative to progress advanced technologies for biopharma manufacturing, it remains to be seen whether CM technologies will see an uptick in adoption within the industry. In this episode of Pharmaceutical Technology’s Drug Digest Video Series, Pharmaceutical Technology editors Chris Spivey and Feliza Mirasol discuss with industry experts the advantages and savings that CM may offer as well as the very real obstacles that might make a fully continuous process not feasible, especially in biologics manufacturing.
Mauricio Futran, owner of Pharmaceutical Engineering Solutions, is a consultant to the pharmaceutical industry working at the interface of technology, R&D, manufacturing, and corporate strategy. He spent nearly 40 years in big pharma, working for Merck, Bristol Myers Squibb (BMS), and Janssen, a Johnson & Johnson company. At Merck and BMS he worked in R&D, rising to vice-president of Process Development at BMS. During those 28 years he was lucky to work on numerous important compounds that went to market, including Primaxin, Mevacor, Proscar, Crixivan , Reyetaz, Entecavir, Muraglitazar, Sprycel, Onglyza (through FDA’s Quality by Design pilot program), Apixiban, Dapagliflozin, and Brivanib.At Janssen, he spent more than 10 years working on manufacturing technology, focusing on integrating data analytics, sensors and models to realize real-time quality awareness and real-time release when possible, along with continuous manufacturing and other manufacturing modalities, covering small molecules, monoclonal antibodies, vaccines, and cell and gene therapy.
Ravendra Singh is faculty of the Department of Chemical and Biochemical Engineering, Rutgers University, NJ, and director of pharmaceutical systems engineering. He is the recipient of the prestigious European Federation of Chemical Engineering (EFCE) Excellence Award. His research focus is continuous manufacturing of drug substance and product. He is principal investigator (PI)/co-PI of several projects funded by FDA, National Science Foundation, and companies. He has published more than 75 papers, edited one pharmaceutical systems engineering book published by Elsevier, written more than 12 book chapters, and presented at more than 130 conferences. He is actively serving as a journal editorial board member, and conference session chair.
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Drug Digest is a tech talk video series with the Pharmaceutical Technology editors, who interview industry experts to discuss the emerging opportunities, obstacles, and advances in the pharmaceutical and biopharmaceutical industry for the research, development, formulation, analysis, upstream and downstream processing, manufacturing, supply chain, and packaging of drug products.