ISPE 2016 Continuous Manufacturing Conference

Continuous manufacturing is one of the most talked-about pharma trends of 2016. Don’t fall behind! Prepare to transform your operations by hearing from renowned global experts who will focus on both small and large molecules at ISPE’s upcoming Continuous Manufacturing Conference.

Compelling Presentations Include:

  • Regulatory and CGMP Considerations for Continuous Manufacturing (FDA)
  • Business Case Drivers and Deployment Strategies (Johnson & Johnson)
  • Drug Product, Portable, Continuous, Miniature, and Modular (Pfizer)
  • Fully Automated Commercial Control Strategy Including RTRT for Drug Product (Vertex)
  • Transforming Biologics Manufacturing through Integrated Continuous Bioprocessing (Genzyme)
  • Process Validation in Continuous Manufacturing (Vertex)
  • View Full Conference Agenda

Learning Objectives:

  • Examine the challenges and benefits of continuous manufacturing from companies with current projects in progress
  • Evaluate regulatory considerations applicable to your company
  • Compare different approaches and tools for effective implementation of control strategy in continuous manufacturing

Global Regulatory Speakers:

  • Dolores Hernan Perez de la Ossa, PhD – Quality Specialist/Human Medicines Evaluation Division, EMA
  • Rapti Madurawe, PhD – Division Director (Acting), Office of Process and Facilities, FDA/CDER/OPQ, Conference Co-Chair
  • David Doleski – Deputy Director (Acting), Office of Process and Facilities, FDA/CDER/OPQ
  • Kurt Brorson, PhD – Lab Chief (Acting), Office of Biotechnology Products, FDA/CDER/OPQ

Representatives from more than 50 Companies Attending:

• AbbVie Inc. • Johnson & Johnson
• Ampio Pharmaceuticals • Johnson Matthey Pharmaceutical Materials
• AstraZeneca • L.B. Bohle, LLC – Germany
• Bill and Melinda Gates Foundation • Mallinckrodt Inc.
• Bristol-Myers Squibb • MedImmune/AstraZeneca Supply Biologics
• Elan Pharma Inc. • Merck
• Eli Lilly & Co. • MHRA
• FDA • Millipore Corp
• F. Hoffmann-La Roche AG – Switzerland • Novartis
• GEA Process Engineering NV – Belgium • Pall Life Sciences
• Genentech • Rutgers University
• Genzyme Corp. • Sanofi
• Gericke AG – Switzerland • Sartorius Stedim Biotech
• Gerteis Machinen & Processing Engineering AG – Switzerland • SmithKline Beecham
• GlaxoSmithKline • UCB Pharma
• Janssen Pharmaceuticals • Vertex Pharmaceuticals, Inc.

Gain a better appreciation of issues related to regulatory, compliance, and validation and help your company advance your plan to implement continuous manufacturing. Register today!

2016 ISPE Continuous Manufacturing Conference