2013 Archived Content

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 

Tuesday, August 20

8:00 am Morning Coffee

Process Improvements 

8:25 Chairperson’s Remarks

Kim Wong, Ph.D., Director, Facilities & cGMP Support, Bioprocess Research & Development, Sanofi Pasteur Ltd.

8:30 Featured Presentation:

Cleaning Process Development and Qualification for Biologics

Kim-WongKim Wong, Ph.D., Director, Facilities & cGMP Support, Bioprocess Research & Development, Sanofi Pasteur Ltd. - Biography 

Expectations of regulatory agencies of cleaning procedures include their development and validation in a similar manner as manufacturing processes. Cleaning process development should employ approaches such as risk analysis and QbD. Among the process parameters that may affect the suitability and performance of a cleaning method are equipment design, selection of cleaning agent, sampling methodology and supportive analytical methods.

9:00 Early-Phase Project Definition

David-BendetDavid Bendet, AIA, LEED AP BD+C, Associate Principal, Senior Project Manager, Perkins+Will - Biography 

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? As an added challenge, financial constraints drive down project budgets while the need to provide energy-efficient, flexible, high-quality and technically demanding facilities continues to increase. This presentation will focus on innovative and analytical behaviors that teams can use to align goals and values to create highest value projects.

9:30 Scale-Up and Automation of Manufacturing Processes – Early Stage Design for Manufacture

Jasmin-KeeJasmin Kee, Ph.D., Manager, Process Engineering, Organogenesis, Inc. - Biography 

Cell therapy manufacturing processes have traditionally grown organically through translation of benchtop processes. In many cases, these processes are manually focused and have stages that may be unsuitable for large-scale production. This can lead to unnecessarily complex scale-up and automation solutions or subsequent development costs to redesign and revalidate the process. How can this issue be addressed? What factors should be considered to enable commercially viable manufacturing processes? When should design for manufacture be integrated in the product lifecycle?

10:00 Sponsored Presentation (Opportunity Available)

10:15 Coffee Break in the Exhibit Hall with Poster Viewing

11:00 Design and Implementation of a cGMP Manufacturing Facility for Production of Biologics using Open Cell Free Synthesis

Heidi-HoffmanHeidi J. Hoffmann, Ph.D., Senior Director, Manufacturing, Sutro Biopharma - Biography 

Sutro Biopharma has developed a production platform utilizing open cell-free protein synthesis (CFPS) technology based on E. coli cell extract, and has commissioned a cGMP facility for production of protein therapeutics, including full-length assembled antibodies, alternate Ab scaffolds, and a wide range of other proteins.  This presentation will discuss the design and retrofit of an existing cGMP facility for implementation of CFPS, including provisions for multi-product use and implementation of single-use technologies, as well as future plans for implementation of next generation processing.

11:30 DoE-Based Screening for Critical Process Parameters of Freezing and Thawing Proteins in a Pilot Freeze Container

Ulrich RoesslUlrich Roessl, Researcher, Products and Formulations, Research Center Pharmaceutical Engineering GmbH - Biography 

A 700mL pilot freeze container was designed in close collaboration with Zeta Biopharma to enable efficient screening for optimal process conditions and composition of cosolutes at a scale where effects arise that are comparable to the industrial case. Process parameters that are most critical for the stability of a model protein are identified in a DoE screening approach and will be considered in scale-up and design of new industrial scale freeze containers.

12:00 pm Optimization of Filling Processes for Biologic Products

Rainer SaedlerRainer Saedler, Ph.D., Group Leader, NBE Formulation & Process Sciences, Drug Product Development, Abbvie GmH & Co. KG

Biologic products require special considerations regarding manufacturing conditions given their potential sensitivity against process related stress. Focusing on the filling of biologic drug solutions, the talk is aimed at providing a discussion of different equipment and process options, taking both output and product quality into account. Means to optimize the filling process, e.g. an overview of pros and cons of different filling equipment, and data on how to improve the filling process by using visualization of the process using high speed video footage will be presented.

12:30 Sponsored Luncheon Presentation (Opportunity Available) or Lunch on Your Own

Optimizing Facility Design 

1:55 Chairperson’s Remarks

David Bendet, AIA, LEED AP BD+C, Associate Principal, Senior Project Manager, Perkins+Will

2:00 Legacy Facilities & Next-Gen Bioprocessing

Eric-BohnEric Bohn, AIA, Principal, jacobs wyper Architects, LLP - Biography  

Change is occurring rapidly in the biotech industry. Single use technology is displacing fixed stainless steel and established pharma companies are rushing to be part of the large molecule revolution. As a result biotech is confronting significant innovation in the design of their facilities. To stay vital now and into the future established facilities need to respond. This presentation discusses how to move beyond the expediencies of the immediate requirements for change and thereby ensure the long term viability of these legacy facilities.

2:30 Five Key Concepts for Making Bioprocess Production Space Effective Work Environments for People

Larry-DiGennaroLarry DiGennaro, AIA, LEED AP BD+C, Science Client Leader, BHDP Architecture - Biography 

In this presentation I will explore the following five concepts, which will make people more effective regardless of the technology deployed: 1. Make the gowning and access to Personnel Protective Equipment covenant; 2. Encourage situational awareness; 3. Provide access to natural light; 4. Think about how people will accomplish non-production related tasks; 5. Carefully plan material and people flow simultaneously.

3:00 Outside the Box: Taking Innovation to the Next Generation of Biomanufacturing Facilities

Jeffrey OdumJeffrey Odum, Director, Operations, Biotech Global Lead, IPS - Biography 

Biomanufacturing is being driven by strong business and regulatory forces to make significant changes. Innovation in the way facilities are conceptualized and designed is focusing on the need for speed and flexibility in both process development and manufacturing. This presentation will focus on concepts and technology tools that will define the next generation of biomanufacturing facilities.

3:30 Refreshment Break in the Exhibit Hall with Poster Viewing

Modular Facilities 

4:15 The Autonomous Biomanufacturing Environment – Integration of the Manufacturing Environment into the Regulatory Horizon

R. Barry HoltzR. Barry Holtz, Ph.D., President, G-Con, LLC - Biography 

Flexible, portable, modular are all terms that have been used to define new approaches to biomanufacturing.  It is important to define these terms and what they really mean in facilities design for biologics manufacture.  The real challenge is to provide environments that are harmonized with new technologies in manufacturing, are capital sparing, and bring a new level of regulatory compliance to match the goals of Quality by Design, Design Space, and Continuous Manufacturing. The focus of this talk is systems integration in an environment that meets the flexibility, autonomy, portability and regulatory aspects of rapidly deployable facilities.  CAPEX and OPEX need to be reduced as the biopharmaceutical manufacturing business moves forward.  The regulatory pressure towards continuous manufacturing and continuous control makes an excellent basis to capitalize on new technology to make higher quality products at less cost.

4:45 Modularization in Biologics Manufacturing – Recent Trends and Developments

Pär AlmhemPär Almhem, President, ModWave and President, ModularPartners - Biography 

Camilla SivertssonCamilla Sivertsson, Vice President, ModWave and Manager, ModularPartners - Biography 

Modularization of biologics manufacturing processes and facilities has been around for a relatively long time. Recently, there has been an increased acceptance of modular concepts, and a wider range of modular solutions are being developed and marketed.  This presentation discusses some of the latest developments in designing and building biologics facilities based on combinations of modular and single-use technologies for a global market. It will provide insight into how single-use technologies, modularization and standardization can help reduce risk, time and cost in projects, domestically and internationally.

5:15 End of Day & Registration for Dinner Short Courses

6:00 Dinner Short Courses*

*Separate registration required

Day 1 | Day 2 | Short Courses | Download Brochure 


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