Cambridge Healthtech Institute's Fifth Annual

Single-Use Technologies and Continuous Processing

( 单次使用技术与连续处理 )

Advancing Bioprocessing through Technological Innovation

2018年1月8日 - 9日

 

The steady adoption of single-use technologies and subsequent move toward continuous processing (CP) for clinical and commercial manufacture has created a great need to evaluate the risks, challenges, opportunities and strategies for implementing these types of technologies into modern day bioprocessing.

Cambridge Healthtech Institute's Fifth Annual Single-Use Technologies and Continuous Processing conference will once again gather technology and equipment providers, end users, and regulators to discuss innovative approaches to current challenges, update companies on the trends in technology, share case studies on successful implementation, and ultimately identify how to derive as much value as possible from these technological advances.

Final Agenda

MONDAY, JANUARY 8

7:30 am Registration and Morning Coffee

CONTINUOUS PROCESSING: CONSIDERATIONS, IMPLEMENTATION AND ENABLING TECHNOLOGIES

9:00 Welcome by Conference Organizer

Kip Harry, Senior Conference Director, Cambridge Healthtech Institute

9:05 Chairperson's Opening Remarks

Dennis Powers, Director, Sales Engineering, G-CON Manufacturing

KEYNOTE PRESENTATION

9:10 A Fully Automated Biopharmaceutical Manufacturing Plant: Process Design, Modeling, and Control

Richard_BraatzRichard D. Braatz, Ph.D., Edwin R. Gilliland Professor of Chemical Engineering, Massachusetts Institute of Technology






9:50 Challenges and Limitations of Continuous Processing and Use of Disposables

Berthold_BoedekerBerthold Boedeker, Ph.D., Chief Scientist, Global Biologics Development, Bayer Pharma AG

Continuous processing in combination with use of disposables has made significant advances in the past years. However, despite many advantages to standard processing, there are still many hurdles ahead of us, before these technologies will be suitable for routine production. This talk will summarize several aspects of necessary improvements as well as some risks associated with these technologies, which are often underestimated in their impact, such as process validation, process characterization and scale-down models.

10:20 Networking Coffee Break

10:45 A Single-Use Strategy to Enable Manufacturing of Affordable Biologics

Renaud_JacquemartRenaud Jacquemart, Ph.D., BioPharma Downstream Process Specialist, Natrix Separations

Single-use technologies and continuous upstream processes have proven to be cost-efficient options to increase biomass production. This case study summarizes how a single-use strategy including a holistic process approach, continuous operation, full utilization of media life (up to 100 cycles per batch) and high-throughput chromatography (residence time ≤6s and loads in kg/L media) can overcome scale limitations and enable cost-efficient manufacturing to support the growing demand for affordable biologics.

11:15 Integrated Continuous Manufacturing Progress and the Life Sciences Industry "Fad or Reality"

Robert_DreamRobert Dream, Ph.D., Managing Director, HDR Company LLC


11:45 Flexible Facility Designs Complementing Continuous Processing

Dennis_PowersDennis Powers, Director, Sales Engineering, G-CON Manufacturing

In the future, traditional cleanroom environments and facilities will need to be more agile to adapt with manufacturers' product portfolio and throughput needs, and will require faster implementation in order to respond to new opportunities and demand around the world. The discussion will focus on advancements in single-use technologies and continuous manufacturing, future manufacturing and facility needs, and innovative cleanroom and facility designs being developed to address these needs.

12:15 pm Sponsored Presentation (Opportunity Available)

12:45 Session Break

1:00 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

Technological Advantages in Single-Use Technologies

2:00 Chairperson's Remarks

Adam Goldstein, MSc, Principal Scientist, Global Technology, Roche/Genentech

2:05 Technology Advances in Single-Use Technologies

Adam_GoldsteinAdam Goldstein, MSc, Principal Scientist, Global Technology, Roche/Genentech

This presentation will focus on challenges single-use applications currently have and may have in the future of biomanufacturing. I will also discuss advances in single-use technologies, with particular emphasis on bulk freeze applications.

2:35 Novel Lipid Supplement Increases mAb Production in Single-Use Bioreactors

Adam_ElhofyAdam Elhofy, Ph.D., CSO, Essential Pharmaceuticals

The objective of lowering costs by achieving higher mAb titers typically comes at the cost of decreased efficacy. Increasing productivity without sacrificing quality is possible with novel bioprocessing approaches. Cell-Ess is an innovative approach to accomplish the previously contradictory goals of decreasing costs, increasing yield, while improving quality.

3:05 Sponsored Presentation (Opportunity Available)

3:20 BuzZ Sessions with Refreshments

Join your peers and colleagues for interactive roundtable discussions.

4:30 BPOG's Five-Year Vision Plan for Disposables

Ken_WongKen Wong, Deputy Director, Process Technology, Sanofi Pasteur

The uptake of disposables in GMP biomanufacturing has been gaining momentum over the last five years. To fully incorporate such disruptive technology into commercial operation, it is necessary for biomanufacturers along with suppliers and regulators to develop and lay out a cohesive plan to realize the full benefit of disposables. During this talk, a five-year vision plan developed by BPOG members will be presented.

5:00 Plastic Components and Systems Used on the Manufacturing of a Drug Product: Current Compendial Perspectives

Desmond_HuntDesmond G. Hunt, Ph.D., Senior Scientific Liaison, Standards Development, United States Pharmacopeia (USP)

USP General Chapter <661.3> contains tests, test methods and specifications for characterizing materials used to construct manufacturing components and for components used in manufacturing systems. In this presentation, the philosophy behind the form and contents of <661.3> is discussed, specifically focusing on similarities and differences between packaging (addressed in <661.1> and <661.2>) and manufacturing.

5:30 Transforming a Scalable High-Yield Perfusion Process from Stainless Steel to a 1000 L Single-Use Bioreactor

Rainer_StahnRainer Stahn, Ph.D., Director, Process Development, Glycotope GmbH

The GlycoExpressTM technology displays a set of human cell lines for the production of glyco-optimized human biopharmaceuticals. A well-established, reproducible perfusion production process at different scales ranging from 1 L R&D scale to 200 L stainless steel GMP bioreactors is transferred to 1000 L single-use. Performance data for upstream data as well as product quality aspects are discussed.

6:00 - 7:15 Welcome Reception in the Exhibit Hall with Poster Viewing

7:15 Close of Day

TUESDAY, JANUARY 9

8:00 am Registration and Morning Coffee

Risk Mitigation Strategies for Single-Use Technologies

8:30 Chairperson's Remarks

Yasser Nashed-Samuel, Ph.D., Principal Scientist, Attribute Sciences, Process Development, Amgen

8:35 Extractables from Single-Use Bioreactors and Impact on Cell Culture Performance

Yasser_Nashed-SamuelYasser Nashed-Samuel, Ph.D., Principal Scientist, Attribute Sciences, Process Development, Amgen

Biopharmaceuticals are drugs manufactured by growing genetically engineered cells in bioreactors to produce a therapeutic protein. Plastic single-use bioreactors are of interest to biopharmaceutical drug manufacturers due to their significant environmental and cost benefits and flexibility over stainless steel bioreactors. Effect of plastics on the biomanufacturing process is not yet completely understood. A case study on extractables from single-use bioreactors and impact on cell culture performance will be presented.

9:05 Extractable Study Design and Data Evaluation of Polymeric Product Materials

Ping_WangPing Wang, Ph.D., Principal Scientist and Senior Manager, Janssen R&D, a Pharmaceutical Company of Johnson & Johnson

Though the application of polymeric disposable materials in the biomanufacturing process has become more popular, the extractables and leachables (E&L) are the major concerns from a safety and quality perspective. The lack of relevant E&L data from suppliers presents end users with a great challenge. Strategies of developing relevant extractable data and applying that in the evaluation of safety concern threshold level will be discussed.

9:35 Sponsored Presentation (Opportunity Available)

9:50 Coffee Break in the Exhibit Hall with Poster Viewing

11:00 Large-Scale Extractable and Leachable Analysis of Single-Use Bioreactors for Biopharmaceutical Manufacture

Jonathan_BonesJonathan Bones, Ph.D., Principal Investigator, Characterisation and Comparability Laboratory, National Institute for Bioprocessing Research and Training

This presentation will describe the characterization of extractables and leachables from disposable bioreactors within a public-private partnership.

11:30 SUS Leachables Testing: Leachables Study Design for Single-Use Components

Kathryn_McGohanKathryn A. McGohan, MS, Associate Scientist II, Manufacturing Sciences and Technology, Materials Science, Bristol-Myers Squibb Co.


12:00 pm Sponsored Presentation (Opportunity Available)

12:30 Session Break

12:45 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:15 Close of Single-Use Technologies and Continuous Processing Conference

* 活动内容有可能不事先告知作更动及调整。