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2014 Archived Content

Cambridge Healthtech Institute’s Inaugural
Flexible Manufacturing of Biopharmaceuticals
Scalable, Compact, Cost-Effective, Modular and Plastic

January 15-16, 2014

Facilitated by the widespread adoption of single-use technologies and driven by the pursuit of multiproduct manufacturing, improved throughput and reduced turnover time, flexible manufacturing facilities are fast becoming the option of choice for the biopharmaceutical industry.

Cambridge Healthtech Institute’s Inaugural Flexible Manufacturing of Biopharmaceuticals conference assesses the regulatory, economic, design and technological advances that are shaping the industry’s manufacturing of the future, and showcases examples of flexible facilities that have been or are being developed.

Day 1 | Day 2 | Download Production Brochure | Speaker Biographies  

TUESDAY, JANUARY 14

1:30-2:00 pm Conference Registration

 

BUZZ Sessions png

2:00 BuzZ Session A (More Details >>)

3:00 Refreshment Break in the Exhibit Hall with Poster Awards

3:45 BuzZ Session B (More Details >>)

4:30-5:00 Short Course Registration

5:00-8:00 Dinner Short Courses (SC8-SC14) More Details >> 

 

WEDNESDAY, JANUARY 15

7:30 am Conference Registration

8:00 Morning Coffee


Trends, Requirements, Economics and Design Considerations for Modular, Flexible Facilities 

8:15 Chairperson's Opening Remarks

Jens H. Vogel, Ph.D., Executive Director & Head, Process Science USA, Boehringer Ingelheim

 

Keynote Presentation

8:20 The Future of Biomanufacturing: Flexible, Compact, Cost-Effective and Modular Facilities

Sadettin S. OzturkSadettin S. Ozturk, Ph.D., Head, Process and Analytical Development, MassBiologics

Recent advances in technology and process optimization resulted in significant enhancements in product yields, allowed robust operation, and established systems for consistent product quality. New cell culture processes are so efficient that they require smaller production facilities than before and they can fully take advantage of the latest single use systems. In this talk we will review the latest developments in process and technologies and provide a vision for the design of future biomanufacturing facilities.

9:00 Regulatory Considerations for Flexible Multiproduct Facilities

John GodshalkJohn Godshalk, Senior Consultant, GMP, CMC, Biologics Consulting Group, Inc. and former Review/Inspector, Division of Manufacturing and Product Quality, CBER, U.S. FDA

This talk will review the regulatory considerations for hybrid, multiproduct facilities and consider if any additional requirements are necessary. We will discuss whether the current facility requirements similarly apply to modular, multiunit, multiproduct facilities and how open ballroom, flexible manufacturing concepts may be assessed.

 

9:30 Personalized Therapeutics, Biosimilars and Pandemic Risks Demand New Approaches to BioManufacturing

SidBackstromSid Backstrom, Director, Business Management, G Con Manufacturing

Today's biopharmaceutical manufacturing facilities are smaller, more flexible, efficient and cost-effective, and they are able to adapt quickly to market changes. With modular systems, we could now place an entire small-scale clinical production line inside a manufacturing suite/environment that could be easily scaled up or redeployed elsewhere as needed. We will explore case studies that are in operation today as a proof of concept and technology robustness and the progress made in this area of patient health needs.

10:00 Coffee Break in the Exhibit Hall With Poster Viewing

10:45 Economics of Modular Facility Design and Construction

Levine HowardHoward L. Levine, Ph.D., President, BioProcess Technology Consultants






11:15 Design Considerations for Platform Development : A New Approach to Advance Manufacturing Facility Design

Rich SmithRich Smith, Director of Business Development - Life Sciences, M+W U.S., Inc. - A Company of the M+W Group





and

Peter CramerPeter Cramer, AIA ,Vice President, M+W U.S., Inc. - A Company of the M+W Group

To achieve reductions in schedule, cost and client operating resources as demanded by our clients, our approach was to capture all of our best practices for flexible manufacturing facilities including energy efficiency, modularity, and best value analyses in one place. We will present an overview of our Advanced Design Platform (ADP) and Advanced Manufacturing Platform (AMP) that will help companies develop their own platform and tools to help modify their platform modular concepts to efficiently meet real world conditions.

11:45 Process and Product Considerations for Flexible Manufacturing

Kenneth D. GreenKenneth D. Green, Ph.D., Director, Continuous Improvement, Global Technical Services, Pfizer, Inc.

This talk will discuss desirable product and process characteristics to enable flexible approaches for continuous and multi-product manufacturing. Manufacturing design and operational procedures will be considered and their influence on process platform development.

 

12:15 pm Flexible and Rapidly Deployed Manufacturing Facilities – Combining Modularization, Standardization and Single Use Strategies

ParAlmhemPar Almhem, Co-Founder and President, ModWave LLC.

 

 

 

 

 

  12:45 Luncheon Presentation: Leveraging Development and Process Platforms to Streamline Delivery of Reliable and Flexible Biomanufacturing Processes 

 McNull_StewartStewart McNaull, Ph.D., Director, Development and Technical Services, Fujifilm Diosynth Biotechnologie 

At Fujifilm Diosynth Biotechnologies (FDB) our process platforms are the foundation upon which we build client processes.  We will describe how FDB uses process platforms along with standard experimental approaches to efficiently develop reliable processes that are customized to achieve the best client outcomes. This process design strategy along with our quality systems knowledge promotes effective facility design and sets a standard framework for manufacturing operations. 


 

 

 

Technology and Process Innovations Driving Flexible Biomanufacturing 

2:00 Chairperson's Remarks

Peter CramerPeter Cramer, AIA ,Vice President, M+W U.S., Inc. - A Company of the M+W Group
 

 

 

2:05 Innovation Driving Fast & Flexible Development and Manufacturing of Biologics

Jens H. VogelJens H. Vogel, Ph.D., Executive Director & Head, Process Science USA, Boehringer Ingelheim

Platform processes have been established for monoclonal antibodies to speed up development and reduce costs. However, in a maturing and increasingly competitive industry, targeted process innovation is again key to more efficiently and sustainably develop diverse biologics portfolios of mAbs and non-mAbs. Examples and data will be shown to illustrate recent and on-going innovations in bioprocess development & manufacturing, such as flexible disposables manufacturing platforms, systems biology based media platforms, HT analytical tools and continuous processing technologies.

2:35 Panel Discussion and Q&A: Technology and Process Innovations Driving Flexible Biomanufacturing

Moderator: Peter Cramer, AIA ,Vice President, M+W U.S., Inc. - A Company of the M+W Group
Panelists: Speakers of the day

 

3:05 Combining Single-Use Technologies with Flexible Workforce to Maximize Utilization of Manufacturing

Wolfgang NoeWolfgang Noe, Ph.D., Vice President, Technical Operations, Agensys Inc.

Use of disposables for manufacturing is becoming a 'standard' in the biotech industry. There is a perception that the use of disposables will make biotech processes more economical, however, very often the effective interaction between involved departments during early clinical manufacturing is underestimated. The author will give a detailed insight into effective manufacturing by using a flexible work model where many departments will contribute to the on-time availability of clinical material as well as the start of clinical trials.

3:35 Selected Oral Poster Presentation

Modular Production Systems at the National Center for Therapeutics Manufacturing

Michael Pishko, Ph.D., Director, National Center for Therapeutics Manufacturing, Texas A&M University

 

3:50 Refreshment Break

4:15 Design, Qualification and Scale-Up to A Disposable Cell Culture Suite to Improve Operational Flexibility

Patrick SheehyPatrick Sheehy, Ph.D., Associate Director, Pharmaceutical Development, Janssen Biologics Ireland

A case study outlining the approach to design and qualification of a cell culture suite utilizing disposable cell culture bioreactors. This facility will improve product change over times, increase operational flexibility and improve cost efficiency. Further, data from the successful scale-up of cell culture processes from lab scale to disposable cell culture bioreactors will be presented. In addition, data outlining a direct comparison of stainless steel and disposable cell culture bioreactor performance will be discussed.

 

4:45 Flexible Manufacturing Solutions for the Animal Health Market

Philip ElrodPhilip Elrod, M.A., Principal Scientist, Zoetis

The Animal Health industry responds to many immediate and emergency needs that maintain the security of food supply as well as controlling zoonotic diseases. In order to do this, we not only need reliable manufacturing techniques but they must also be extremely inexpensive by comparison to human vaccine standards, yet generally produced to similar quality standards. This presentation will discuss aspects of process robustness and the challenges of manufacturing in a BSL-3 environment.

5:15-6:30 Reception in the Exhibit Hall With Poster Viewing

 

Day 1 | Day 2 | Download Production Brochure | Speaker Biographies