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Manufacturing Breakfast Briefing: Continuous Bio/Pharmaceutical Manufacturing: Advanced Technology for Improved Efficiency and Quality

March 30 @ 8:00 am - 11:00 am

Join FDA and New Jersey Industry Professionals
BioNJ’s Manufacturing Breakfast Briefing 

Thursday, March 30 | 8:00 a.m. – 11:30 a.m.
Rutgers University | Busch Campus Student Center | Multi-Purpose Room


During BioNJ’s Manufacturing Briefing, several new technologies enabling continuous bioprocessing will be presented, including SMB chromatography and single-pass tangential-flow filtration. Additionally, Rutgers Advanced Materials Initiative will present its pilot process for continuous production of drug product from drug substance.

 

Agenda:
8:00 a.m. – 8:45 a.m.: Registration and Networking Breakfast
8:45 a.m. – 9:00 a.m.: Welcome by BioNJ and Rutgers University
9:00 a.m. – 11:00 a.m.: Program
11:00 a.m. – 11:30 a.m.: Optional Tour: Center for Structured Organic Particulate Systems (C-SOPS) Labs at Rutgers School of Engineering

 

Speakers:

Sarah Arden, Ph.D., U.S. Food & Drug Administration, CDER/Office of Biotechnology Products, Division of Biotechnology Review and Research II

Dr. Arden serves as a product quality reviewer with a focus on chemistry, manufacturing and control programs as well as immunogenicity of biotherapeutics in development and post-market phases in the Office of Biotechnology Products at the FDA Center for Drug Evaluation and Research. She is a member of the FDA Center of Excellence for Manufacturing Science and Innovation and informs the Agency on matters related to emerging technologies, public-private initiatives and industrial biomanufacturing consortia.

 

Michael Egholm, Ph.D., Vice President & General Manager, Biopharmaceuticals, Pall Life Sciences

Dr. Egholm is responsible for the operations and strategic direction of Pall’s biopharmaceutical business unit, spearheading the company’s efforts to continuously improve bioprocesses for customers. With a prestigious industry background, Dr. Egholm brings more than two decades of expertise in leading the development and commercialization of innovative technologies. Formerly Chief Technology Officer and Vice President of Research & Development at 454 Life Sciences Corp., he was at the helm of several high-profile programs, including the Neanderthal Sequencing project and the sequencing of the first individual human genome.

 

Douglas Hausner, Ph.D., Associate Director, Department of Chemical & Biochemical Engineering, Rutgers University

Dr. Hausner is currently the Associate Director for Industrial Relations and Business Development with the Engineering Research Center for Structured Organic Particulate Systems (C-SOPS) based at Rutgers University. C-SOPS is the largest academic/industrial research consortium focused on pharmaceutical applications, involving over 100 academic researchers, and more than 50 industrial partners.   C-SOPS has been directly involved in working with major pharmaceutical companies and the FDA on the first processes for continuous manufacturing of pharmaceutical solid dose products.

 

Kenneth Kang, Ph.D., Director of Process Development, Patheon

Dr. Kang has over 20 years of experience on process development in the biotechnology /biopharmaceutical industry. His role at Patheon includes managing the early and late stage process development, and implementing new/advanced technologies in the field of cell culture and purification with a focus on streamlining current manufacturing processes. Prior to Patheon, Dr. Kang was Head of Protein Purification Team for Eli Lilly, responsible for managing the purification process development, identifying, evaluating and implementing new and advanced technologies in the field of protein purification with a focus on membrane chromatography and streamlining downstream processes.


Who Should Attend:
CFOs/Executive and Sr. Management facing manufacturing investment decisions, Operations Business Heads, Manufacturing Professionals, Site Engineers, Supply Chain Professionals and CDMOs/CMOs

Join us for this premier opportunity to network and share perspectives with other leading industry professionals. Click here to register. Registration is $60 for BioNJ Members and $85 for Future Members. Contact Edie Esposito at EEsposito@BioNJ.org to learn about sponsorship opportunities.

Details

Date:
March 30
Time:
8:00 am - 11:00 am

Venue

Rutgers – Busch Campus Center
604 Bartholomew Road
Piscataway, NJ 08854 United States
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