Education Details
Education: Plenary ♦ Education Topics ♦ Case Study ♦ Facility Tours
How do smart companies design and develop formulations and manufacturing processes to insure pre-designed product quality?
Understand how planning and controlling pharmaceutical product evolution can lead to superior quality, better resource use and increased business effectiveness.
Plenary Session
The Plenary Session will consist of Industry and Regulatory speakers as they discuss relevant topics.
Speakers
Dr. Oliver Smithies
University of North Carolina School of Medicine, Nobel Laureate
Where Do Ideas Come From?
Dr. James Talton
CEO Nanotherapeutics
Nanotherapeutics Advanced Development and Manufacturing (NANO-ADM): A Look at a Future Manufacturing Model
- Dave Doleski, FDA, USA - Invited
Education Topics
Biopharmaceutical Manufacturing and Process Development
Leaders
- Susan Beckert, Director Technology Southeast, Merck, USA
- Robert Dream, PE, Principal, HDR COMPANY LLC, USA
The next generation of biomanufacturing processes will implement traditional and new platform technologies as well as single-use applications to meet unit operation needs.
Hear how local companies have tackled the challenges with process innovation and learn through case studies on single-use technologies
Presentations
- Greg Benson, Process Engineer, Merck & Co Inc, USA
- Scott Billman, Director, Engineering, Novartis Vaccines & Diagnostics Inc, USA
- Robert Dream, PE, Principal, HDR COMPANY LLC, USA
- Jeffrey Johnson, Director, Global Engineering, Merck & Co Inc, USA
- Stephan Orichowskyj, Sr Director - Biotechnology, Hargrove Life Sciences, USA
- Todd Talarico, Medicago USA, USA
Facility Design and Integration
Leaders
- Steven Miller, CPIP, Director, Process Eng, MedImmune, USA
- Jeffery Odum, CPIP, Biotech SME, Opts Manager, IPS, USA
The Facility of the Future will be one that has different facility attributes than the traditional stainless-steel basis. Flexibility, diverse product mixes, rapid product development, increased reliance on closed system design and operational requirements will become the drivers of facility design.
Interact with global Subject Matter Experts in biomanufacturing facility design and learn how new facility delivery models are changing the way companies approach facility design.
Presentations
- Peter Bigelow, President, SHA, Inc., USA
- Clark Byrum, President/CEO, Biologics Modular, LLC, USA
- Ruben Carbonell, Director, Biomanufacturing Training & Educ Ctr, USA
- Stephen Hudd, Dir. Global Engineering, Biogen Idec, USA
- Scott Keetch, Director of Engineering, Biogen Idec, USA
- Steven Miller, CPIP, Director, Process Eng, MedImmune, USA
- Jordan Sealock, Project Analyst, Independent Project Analysis, Inc., USA
- Paul Smock, Senior. Director, QA, MedImmune LLC, USA
- James Talton, PhD, President and Chief Executive Officer, Nanotherapeutics,
- Jens Vogel, PhD, Executive Director, Process Science & Technology Office, Boehringer Ingelheim,
- Mark Witcher, Ph.D., Principal Consultant, IPS, USA
Compliance and Process Validation
Leaders
- Charles Stock, CxA, Sr Principal/Sr Vice President, IPS, USA
- Mark Yates, PhD, Principal Validation Specialist, Pfizer, USA
The regulatory landscape changes of the past two years will have a profound impact on the future biomanufacturing facilities and their design and operations. Implementing risk-based programs with Lifecycle/Process Validation approaches will become crucial as key success drivers.
A-VAX Case Study
Leaders
- Bradley Kosiba, PhD, CPIP, Principal, BK Collaborative LLC, USA
- Sam Venugopal, Director, PricewaterhouseCoopers LLP, USA
Vaccines have become an important focus of the biotech industry. Following the publication of the A-Mab case study in 2009 that applied Quality by Design (QbD) principles to the production of an example monoclonal antibody, suggestions were made to conduct a vaccine case study.
This session will allow you to identify the specific challenges related to QbD and identify ways in which these challenges can be overcome. Hear key challenges faced by the regulators as they attempt to better define their expectations related to QbD.
Presentations
- Mike Kosinski, Distinguished Investigator, Merck,
- Paul Rohlfing, Sr. Director Global CMC, Pfizer, USA
- Michael Schwartz, Associate Director, Global Regulatory Affairs, GlaxoSmithKline-Vaccines,
- Michael Washabaugh, PhD, Sr. Director, MedImmune,
Facility Tours
On Wednesday afternoon, ISPE attendees will have the opportunity to look at top-level facilities and learn about their operations. Limited seating available so, register online today!
Price: $50/per person.
Medicago Vaccine Research Facility
The Medicago USA Vaccine Research Facility, Production Facility
and Greenhouse in Durham, North Carolina, focuses on commercial-grade vaccines derived from plants. Medicago
grows its flu vaccine using a combination of agrobacteria and wild tobacco plants. The facility features a
27,000-square-foot fully automated greenhouse, customized infiltration systems and a state-of-the-art
extraction and purification unit along with laboratories and office space. The cost-effective,
state-of-the-art facility has allowed Medicago to demonstrate the scalable manufacturing of the company’s
plant-expressed VLP vaccines in the United States.
Note: Closed toed shoes required during the site visit. We also suggest that all visitors wear pants, as skirts are not the best attire for a portion of the tour. Flash photography permitted.
BTEC - Biomanufacturing Training and Education Center
The BTEC facility is a unique, cross-disciplinary instructional
center that provides educational and training opportunities to develop skilled professionals for the
biomanufacturing industry. It also provides bioprocess development and analytical services to a wide range of
customers from academia and industry.
Additionally, the labs were specifically designed to provide education in areas including: quadplexed fermenters bioreactor preparation, cleaning and operation, cell and protein harvest and recovery, protein purification, product characterization and sterile filling and packaging.
Note: Cameras are permitted and encouraged. No special clothing is required.
Thank you to our Top Tier Sponsors
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