Monday, December 4 2017
08.00 Coffee & Registration
09.00 Chair’s Opening Remarks
Adhering to and Delivering Beyond Regulatory Requirements
09.10 Keynote Address: Why Would a Startup Self-Perform Phase 1 Aseptic Processing? Case Studies
- Greg Corcoran General Manager/ Site Head, AntriaBio, Inc.
• “What were they thinking?!” Business drivers to self-perform vs. contract
• Aseptic process controls and considerations in Ph1
• Understanding and managing risks, particularly with manual aseptic processes in clinical manufacturing stage
• What is the regulatory expectation for compliance for clinical sterile manufacturing?
09.40 How to Make Product Good with Aging Facilities and Equipment
- Claus Weisemann Vice President, Quality Affairs, Luitpold Pharmaceuticals
• How to validate and define quality standards for sterile products manufactured in aging facilities?
• Quality assurance challenges – routine inspections and audits
• Case study of maintaining cGMP – challenges and solutions
10.10 Morning Refreshments & Speed Networking
The Full Journey of Aseptic Processing & Sterilization
11.30 New or Old Facility, Understanding, Assessing and Controlling Aseptic Manufacturing Risks
- Philip Duncanson Director of Quality Assurance & Microbiology, AstraZeneca
• Contamination control plan – get started before you start: When should you do it? What should it include?
• Impacts and implications of revised version for EU GMP requirements and comparison with FDA’s guidelines
• Challenges of ensuring compliance at manufacturing plants across the world
12.00 Terminal Sterilization of Lyophilies: Impact of Ionizing Radiation on Product Stability
- Evgenyi Shalaev Research Investigator, Allergan
• Radiation type and dose
• Product type, e.g. small molecule vs. protein
• Excipients and stability of freeze-dried proteins during irradiation
12.30 Lunch & Networking
13.45 Roundtable Discussion – Defining Aseptic Processing and Sterilization Standards, and Translating into Actions with Your Partners
- Tony Van Hoose CEO , Global Aseptic Process Solutions, LLC
Audience will be split into groups to discuss their thoughts and challenges relating to outsourced aseptic processing and sterilization, and how they should work with their CMO partners to standardize procedures and quality requirements, particularly in multisites situation.
At the end of this session, the groups will reconvene to share their findings and one top tip for peers.
14.30 Advanced Aseptic Process Monitoring
- Nithin Raghunathan Research Scientist , Purdue University
• Real time monitoring of product temperature and environment variation
• Sensor accuracy and latest developments
• Ease of scaling up
15.00 Challenges and Opportunities in Filling Highly Viscous Biologics with New Pump and Closure Processing Technologies
- Nan Yung Lin Independent Expert,
- Biologics drug product processing with respect to primary containers for drug delivery devices
- Opportunities and challenges with next gen auto-injectors and onbody delivery systems