Trends in Biologics Manufacturing (with MedImmune Tour of Therapeutic Protein facility) (E09)
Sponsored by the North American Education Committee and the Biotech Community of Practice.
The focus is on manufacturing. How did the manufacturers who produced H1N1 vaccine manage the challenge? What did they learn? What can you learn from their experience to help your company be able to manage both manufacturing and supply chain challenges to meet emergency needs? Attend and hear from the H1N1 manufacturers, including CSL Biotherapeutics, GlaxoSmithKline Biologicals, MedImmune, and Novartis Vaccines and Diagnostics, as well as the U.S. Health and Human Services Office of Vaccines.
This two-day session also provides a leading edge look at the latest trends in the manufacture of high titer recombinant proteins. The session on therapeutic proteins will focus on logical ways to adapt existing facilities to process cultures with much higher titers. Genentech will provide an insight into their methodical approach for de-bottlenecking an existing facility. Pfizer will present a case study that explores the pros and cons of different strategies for making buffers.
Registrants will have an exclusive opportunity for a half day tour of MedImmune’s Biologics Manufacturing Facility at the Frederick Manufacturing Center in Maryland. Operations include 331,000 sq ft of manufacturing floor space for commercial-scale mammalian cell culture, downstream purification, media/buffer prep and other process support systems.
The MedImmune Biologics Manufacturing Facility tour will be the afternoon of Wednesday June 9th and will be limited to the first 50 registrants. Transportation to and from the site will be provided by ISPE.
- Jeff Campie, USA
- Richard Forsyth, Senior Consultant, Hyde Engineering + Consulting, USA
- Nigel Hamilton, Global Quality, Strategy and Process Excellence, Sanofi Aventis, United Kingdom
- Aisling Horan, Validation Scientist, Alkermes Plc, Ireland
- Edwin Melendez, Principle Consultant, Parexel, USA
- Mark O'Reilly, Director Engineering, Alkermes Pharma Ireland Ltd, Ireland
- Kimberly Ray, A. Director Project Mgmt, Oso Biopharmaceuticals Mfg LLC, USA
- Julian Wilkins, Vice President, PharmaConsult US Inc, USA
- Paul Wreglesworth, Independent Consultant, United Kingdom
Communities of Practice (COPs)
- 1 - Product Development
- A. Formulation, clinical phases, and manufacture
- B. Technology transfer
- C. Production scale-up and optimization
- 2 - Facilities and equipment
- A. Design and construction/installation
- B. Commissioning and qualification as a risk management strategy
- C. Operation and maintenance
- D. Controls and automation
- 3 - Information systems
- 4 - Supply chain management
- A. Materials management
- B. Operational economics
- C. Warehouse and distribution management
- 5 - Production systems
- A. Production unit operations - drug (small molecule) and biologics
- B. Production management
- C. Production Control
- 6 - Regulatory compliance (includes drugs, environmental, health and safety)
- A. Government regulations
- B. Standards, practices, and guides
- 7 - Quality systems
- A. Risk management and Quality Management System (QMS)
- B. Systems validation (changed from Validated Controls)
ISPE will provide continuing education units (ISPE CEUs) for all North American seminars and courses, including educational programming at the ISPE Annual Meeting. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession.
Delegates attending European seminars and courses will receive a Certificate of Attendance, as ISPE CEUs are currently not offered at European events. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be sent via email within four weeks of evaluation materials. One hour of education programming equals 0.1 ISPE CEU credits.