August 19-20, 2013
Cambridge Healthtech Institute’s Inaugural
Facilities for Manufacturing Biologics
Exploring Today & The Future
Day 1 | Day 2 | Short Courses | Download Brochure
Monday, August 19
1:00 pm Chairperson’s Opening Remarks
David M. Marks, Principal & Founder, DME Alliance Engineering Consultants
1:10 Opening Keynote Presentation:
HHS Centers for Innovation in Advanced Development & Manufacturing
R. Thomas Warf, Senior Program Manager, Product Process Development Analysis, Influenza and Emerging Diseases Division, Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response, U.S. Department of Health and Human Services
HHS/BARDA established in June 2012 three new Centers for Innovation in Advanced Development and Manufacturing to assist developers of biodefense medical countermeasures and produce vaccines and biological products in the event of an influenza pandemic or an emerging disease outbreak. The HHS Medical Countermeasure Review (2010) recommended the creation of the Centers as a strategic initiative to address the difficulty that biotech companies experienced in the development of biodefense medical countermeasures and to expand and modernize a more efficient domestic pandemic influenza vaccine manufacturing capability. The Centers are public-private partnerships that utilize novel flexible and nimble manufacturing approaches coupled to modern cell-, recombinant-, and molecular-based vaccine and biological product technologies. The Centers train scientists and technicians who will operate these facilities and meet the national need for more highly-skilled personnel for the biotech and pharmaceutical industries.
1:45 Flex-Facility Paradigms: Future Trends and Challenges for Multi-Product Biomanufacturing
David M. Marks, Principal & Founder, DME Alliance Engineering Consultants
A convergence of business drivers, regulatory constraints and emerging technologies is driving the evolution of new approaches to biomanufacturing process and facility design for improved flexibility, reliability and throughput. This presentation will explore the key concepts and enabling technologies for future facilities and suggest strategies for their implementation.
2:15 The Impact of Single-Use Technologies on Segregation, Campaigning and Product Changeover in Multiproduct Facilities
Trevor Deeks, Ph.D., Senior Director, Manufacturing Management Services
With the advent of single-use disposable systems for manufacturing, the campaign changeover has become much less difficult to demonstrate, and segregation is no longer an absolutely essential requirement in many cases. This has led to more flexible manufacturing facilities, which in turn is leading to lower facility investment costs at all stages of development. The impact of single-use technologies is illustrated with reference to some case studies involving vaccines and potent compounds.
2:45 Refreshment Break
3:15 Flexible Manufacturing
Sanjay B. Shah, Director & Head, Biologics Operations, Syngene International Ltd.
I will discuss how to best leverage today’s flexible manufacturing solutions for clinical manufacturing or commercial launch with speed, precision and, of course, at lower cost. My talk will draw on actual operating experience, looking at what works best for BioPharma companies, particularly regarding implementing single-use technologies.
3:45 Flexible Biopharmaceutical Production Facilities
Scott Kaplan, Senior Director of Project Development, Pharmadule Morimatsu, Inc.
My presentation will identify the challenges of getting a new biomanufacturing facility through design, construction, and start-up in a timely manner, balancing the financial risks of committing to a capital project too early with those associated with not getting a treatment to market to help patients. I will present a solution, leveraging the advantages of single-use process equipment and modular design and fabrication, to streamline the delivery process while enhancing predictability and mitigating risk.
4:15 Small-Group Breakout Discussions
This session provides the opportunity to discuss a focused topic with peers from around the world in an open, collegial setting. Select from the list of topics available and join the moderated discussion to share ideas, gain insights, establish collaborations or commiserate about persistent challenges. Then continue the discussion as you head into the lively exhibit hall for information about the latest technologies.
5:15 Discussion Report-Outs
5:30 Grand Opening Reception in the Exhibit Hall with Poster Viewing
7:00 Close of Day
Day 1 | Day 2 | Short Courses | Download Brochure