Advancements in the Implementation of Continuous Manufacturing

In this episode of Drug Digest, PharmTech editors discuss the changing environment that is facilitating greater acceptance of continuous manufacturing technologies as well as advances and challenges in implementing these technologies.

Register Free: https://www.pharmtech.com/pt_w/continuous-manufacturing

Event Overview

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, PharmTech 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.
Interviews featuring:

• Mauricio Futran, Vice-President, Process Science and Advanced Analytics, Johnson & Johnson
• Ravendra Singh, PhD, Faculty, Department of Chemical and Biochemical Engineering, Rutgers University

This episode of Drug Digest is sponsored by:

• Veltek Associates, Inc.

Key Learning Objectives

• Learn the progress to date that CM efforts have achieved
• Discuss the benefits that CM can offer
• Explore the challenges and reasons why a fully continuous process may not be feasible or desirable (e.g., in the case of biologics)

Who Should Attend

• CDMOs, CMOs
• Biologics developers
• Small-molecule API developers
• OEMs
• Process development engineers, scale-up

Speakers

Mauricio Futran
Owner
Pharmaceutical Engineering Solutions

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, PhD
Faculty, Department of Chemical and Biochemical Engineering
Rutgers University

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 ournal editorial board member, and conference session chair.

Register Free: https://www.pharmtech.com/pt_w/continuous-manufacturing