2013 Biotech Conference


Education Details

Education: PlenaryEducation TopicsCase StudyFacility 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.

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Plenary Session 

The Plenary Session will consist of Industry and Regulatory speakers as they discuss relevant topics.


 PhotoDr. Oliver Smithies
University of North Carolina School of Medicine, Nobel Laureate

Where Do Ideas Come From?

 PhotoDr. James Talton
CEO Nanotherapeutics

Nanotherapeutics Advanced Development and Manufacturing (NANO-ADM): A Look at a Future Manufacturing Model

 PhotoDave Doleski

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Education Topics 

Biopharmaceutical Manufacturing and Process Development


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


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Facility Design and Integration


  • Steven Miller, CPIP, Director, Eng Technical Svcs, AstraZeneca, USA
  • Jeffery Odum, CPIP, Director Ops, Biotech Lead, 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.


  • Leader: Steven Miller, CPIP, Director, Eng Technical Svcs, AstraZeneca, USA
  • Clark Byrum, CEO, Biologics Modular, LLC, USA
  • Jordan Sealock, Project Analyst, Independent Project Analysis, Inc., USA
  • Paul Smock, Sr. Director, Technical Quality, MedImmune LLC, USA
  • Brian To, Associate Director of Protein Science, Boehringer-Ingelheim, USA
  • Mark Witcher, PhD, Principal Consultant, IPS, USA

Next Generation Manufacturing Facilities Panel Discussion

  • Peter Bigelow, President, XCell Strategic Consulting, LLC., USA
  • Ruben Carbonell, Director, Biomanufacturing Training & Educ Ctr, USA
  • Stephen Hudd, Dir. Global Engineering, Biogen Idec, USA
  • James Talton, PhD, President and Chief Executive Officer, Nanotherapeutics, USA
  • Mark Witcher, PhD, Principal Consultant, IPS, USA

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Compliance and Process Validation


  • 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.


Industry & FDA Panel Discussion

Invited Panelists:

  • David Doleski, Director, Office of Manufacturing and Product Quality, FDA/CDER/OC/DGMPA, USA
  • Eric Mabee, Sr Associate II Quality Engineering, Biogen Idec, USA
  • Viviana Matta, Drug Consumer Safety Officer, FDA, USA
  • Adam Tessneer, Senior Technical Operations Engineer, Fujifilm Diosynth Biotechnologies, USA

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A-VAX Case Study Understanding and Practical Applications 

View the entire Case Study ( 8 MB)


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.


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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

Medicago Facility ImageThe 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. 

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BTEC - Biomanufacturing Training and Education Center

BTEC Facility ImageThe 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.

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Thank you to our Top Tier Sponsors

  • Pinnacle Sponsor
  • Pinnacle Sponsor
  • Pinnacle Sponsor
  • Host Sponsor
  • Media Partner

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