Embracing Change: How Innovators are Advancing Continuous Biopharma Manufacturing

June 12, 2019 8:00 AM - 10:00 AM

MassBio, 300 Technology Square 8th Fl, Cambridge, MA 02139

Building on the realization of continuous manufacturing for commercial small molecule APIs and drug products, the dominos finally are beginning to fall into place for the advancement of integrated processes for biopharmaceutical applications. Regulatory engagement, novel and disruptive process and measurement technologies, and simple economics all are playing key roles in recent progress. This forum, intended for a broad audience of scientists and business leaders across the MassBio community, will explore how each of these change-agents are helping to overcome long-time deterrents and, in doing so, have the potential for improving manufacturing reliability and product quality – thereby reducing risks to patients and other key stakeholders.

Discussion and Key Take-Aways Will Include:

  1. Establishing the business case for continuous biomanufacturing – when and for what applications does it make sense?
  2. Applying single-use technologies, automation, and other innovations to enable success in downstream continuous processing.
  3. Advances in measurement and process analytical technologies to enable process/product understanding in alignment with regulatory guidances.
Forum Bonus: We will have extended networking from 10am-11am so you can meet with Bio-Process Systems Alliance, BioPhorum and NIIMBL organizations to learn how they work with industry to accelerate manufacturing innovation as well as find out about their latest white papers, reports and events.
Vice President, Pharmaceutical Sciences and Technology, Visterra
Jean Bender joined Visterra in 2018 and has over 25 years of bioprocess engineering experience within the biopharmaceutical industry. Prior to Visterra, Jean served as Senior Director, BioProcess Engineering at Medimmune LLC where she was responsible for process development engineering, scale-up and transfer of drug substance processes to internal and external manufacturing sites. Previously she held roles of increasing responsibility within Genentech Inc., most recently as Principal Engineer in Purification Development in which she was responsible for tech transfer and licensure of monoclonal antibody processes within the Genentech/Roche manufacturing network. She has authored more than 15 publications and presentations within her field and holds a patent for preparing highly concentrated antibodies by ultrafiltration. Jean received her MS in Chemical Engineering from the University of California, Berkeley and her BS in Chemical Engineering from Lehigh University.