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August 19-20, 2013

Cambridge Healthtech Institute’s Inaugural
Facilities for Manufacturing Biologics

Exploring Today & The Future


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Monday, August 19


Strategies for Flexible Facilities 

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

Tom-WharfR. 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 - Biography 

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

Dave-MarksDavid M. Marks, Principal & Founder, DME Alliance Engineering Consultants - Biography 

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-deeksTrevor Deeks, Ph.D., Senior Director, Manufacturing Management Services - Biography 

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-ShahSanjay B. Shah, Director & Head, Biologics Operations, Syngene International Ltd. - Biography 

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-KaplanScott Kaplan, Senior Director of Project Development, Pharmadule Morimatsu, Inc. - Biography 

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.

1.  Process Validation – A Lifecycle Approach
Moderator:  Kim Wong, Ph.D., Director, Facilities & cGMP Support, Bioprocess Research & Development, Sanofi Pasteur Ltd.
The 2011 FDA Guidance document titled "Process Validation: General Principles and Practices" aligns the agency's perpsective on pharmaceutical process development with current practices such as those outlined in ICH documents. A lifecycle approach for the design, qualification and continued verficiation of processes for the manufacture of drugs development is endorsed. Impact of implementation on the development of new drug products as well as agreement with the draft EMA guidelines will be discussed.

2.  Early Phase Project Definition
Moderator:  David Bendet, AIA, LEED AP BD+C, Associate Principal, Senior Project Manager, Perkins+Will
At project initiation, when only a basic need exists, how can project teams quickly and accurately generate information about the physical project to facilitate the decision-making process and guide project definition?
    • How to establish project expectations (for client and design/delivery teams)
    • What behaviors support decision-making?
    • How to engage Stakeholders – client, design team, builders.
    • Are there analytical tools and strategies you’ve found helpful?
    • How do you establish a Budget at project conception?
    • Do you use commitment-based scheduling tools to define the delivery?
    • What are important Quality expectations, how are they defined?
    • Is energy efficiency / saving utilities important?
    • How do you define need for flexibility, redundancy?

3.  Considerations for Frozen Storage of High-Value Biological Materials:  Integrating Financial, Supply and GMP Needs for Bio-manufacturing Facilities
Moderator: M. Hite Baker, P.E., Principal Process Engineer, DME Alliance, Inc.
What defines a GMP freezer?
    • How aware is your organization of the high-value of biological material stored in your GMP freezers?  $1MM?  $10MM?        $100MM? 
    • Which freezers are critical and which are not?
    • Is “dollar value” the only consideration to determine the criticality of GMP storage freezers?  How about impact upon supply?  Impact upon future ability to produce?
    • How many “eggs should you put into one basket?”
    • What would be the impact of a catastrophic failure of a large GMP freezer at your site? 
    • What are your contingency options?  On-site spare freezers, emergency generators, liquid nitrogen backup, off-site storage, portable trailers?
    • Which design and operational strategy is most reliable?  Centralized or distributed freezer storage?
    • Does your organization treat change control for GMP freezers like other GMP process equipment (e.g., autoclaves), or do you treat GMP freezers like ordinary site utilities (e.g., a freezer in your company’s cafeteria)?
    • Are your GMP freezers qualified?  What are the qualification requirements?
    • Must temperature-monitoring, alarming and data trending be CFR Part 11 compliant the same as other GMP process equipment?  Is your Building Automation System (BAS) compliant?
    • Who controls the set point and alarm limits for your GMP freezers?  Are changes done under maintenance work orders only, or do changes require formal change control?
    • How do you define a temperature excursion when ordinary operations drive transient storage temperatures outside of alarm limits?  Are common sense alarm delays OK, or need product data?

4.  Flexible Upstream Bioprocess Manufacturing Technology
Moderator:  David M. Marks, Principal & Founder, DME Alliance Engineering Consultants
Traditional upstream bioprocess technology required a compromise between flexibility and reliability.  Flexibility was for the pilot plant, where process development requirements are paramount.  GMP production facilities require reliability, where product quality was and still is essential.  The business drivers for today’s commercial multiproduct biologics manufacturing facilities are demanding both flexibility and reliability, and new strategies and technologies are evolving to meet this challenge.
    • Why is it difficult to program flexibility in upstream biologics manufacturing?
    • What are the limitations of conventional upstream technology to accommodate process and production flexibility?
    • What approaches have proven successful for programming flexibility in upstream manufacturing?
    • How does manufacturing scale and level of process automation impact the available options for improving flexibility?
    • How can single-use technology be used to improve the flexibility of upstream manufacturing?
    • Which upstream unit operations have successfully employed single-use technology in cGMP manufacturing?
    • What are the challenges associated with implementing production scale single-use bioreactors, harvest and recovery  systems?

5.  The Impact of Single-Use Technologies on Manufacturing
Moderator:  TBA
    • Implementation challenges
    • Interoperability of components
    • Impact on productivity and cost

5:15 Discussion Report-Outs

5:30 Grand Opening Reception in the Exhibit Hall with Poster Viewing

7:00 Close of Day



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