PepTalk 2017
PepTalk 2017
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Cambridge Healthtech Institute’s Fourth Annual
Single-Use Technologies and Continuous Processing
Advancing Bioprocessing through Technological Innovation
January 9-10, 2017 | Hilton San Diego Bayfront | San Diego, CA


The steady adoption of single-use technologies and subsequent move toward continuous processing for clinical and commercial manufacture have 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 Fourth Annual Single-Use Technologies and Continuous Processing conference once again gathers technology providers and end users to discuss approaches to current challenges, trends in technology, case studies on successful implementation, and ultimately identify how to derive as much value as possible from single-use technologies.

SUNDAY, JANUARY 8

4:00 - 5:30 pm Registration

5:00 - 8:00 Dinner Short Courses

MONDAY, JANUARY 9

7:30 am Conference Registration and Morning Coffee

CONTINUOUS PROCESSING: CONSIDERATIONS, IMPLEMENTATION AND ENABLING TECHNOLOGIES

9:00 Welcome by Conference Organizer

Kip Harry, Conference Director, Cambridge Healthtech Institute

9:05 Chairperson’s Opening Remarks

Dennis Jenke, Ph.D., Baxter Distinguished Scientist, Technology Resources, Baxter Healthcare Corp.


FEATURED PRESENTATION

9:10 Challenges and Limitations of Continuous Processing and Use of Disposables

Berthold 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.

9:50 Economics of Continuous Processing vs. Traditional Batch

Jeff Johnson, New Technology Lead, Merck & Co., Inc.

Opportunities for applying new technologies integrated with continuous processing and enabled by single use will be discussed for monoclonal antibody production. The combined efficiencies gained by continuous processing will be compared by economic criteria to current manufacturing methods. In addition, the impact of the new approaches to multi product manufacturing facilities will be described.

10:20 Coffee Break

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

Renaud Jacquemart, Ph.D., Author, BioProcess International

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 Scalability of Growth Characteristics and Product Quality: Efficient Downscale Perfusion Bioprocess Development Using DOE Studies

Steffen Kreye, Scientist, USP Development, Glycotope GmbH

The sedimentation-based down-scale perfusion system SAM (10mL reactor volume) has been developed to characterize the upstream process parameters and their influence on product quality. Using DoE studies, we gain a highly efficient method for media development as well as process optimization to achieve higher cell densities and higher productivities. Scalability and reproducibility of perfusions bioreactors (10mL-1000L) will be highlighted with data of the fully human, high-yield production and glycooptimization platform GlycoExpress (GEX).

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

STANDARDS AND RECOMMENDATIONS
FOR SINGLE-USE EQUIPMENT AND PROCESS

2:00 Chairperson’s Remarks

Jerold Martin, MSc, Chairman, BPSA BoD and Technology (E+L) Committee

2:05 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.

2:35 USP’s Risk Evaluation Matrix

Dennis_JenkeDennis Jenke, Ph.D., Baxter Distinguished Scientist, Technology Resources, Baxter Healthcare Corp.

During this presentation, I will go into an essential aspect of <661.3>, the Risk Evaluation Matrix, in detail, thus providing the attedees with necessary clarifications and insights.

3:05 Sponsored Presentation (Opportunity Available)

3:20 Refreshment Break in the Exhibit Hall with Poster Viewing

4:00 Wide-Scale Adoption of Single-Use Systems – What Are the Challenges ahead from the Regulators’, Suppliers’ and End Users’ Perspectives?

Jerold Martin, MSc, Chairman, BPSA BoD and Technology (E+L) Committee

This presentation will focus on continuing developments in implementation and standardization of single use technologies and practices, especially the ongoing efforts to standardize extractables testing, but also other activites like change control and notification, GMP practices for particulate control, integrity testing, etc. I will also focus on BPSA activities along with the those of USP, ISO, ASME and ASTM.

4:30 Co-Presentation: Update on BPOG / BPSA Collaborative Efforts on Single-Use Systems

Eric_IsbergEric Isberg, Member, Change Notification and User Specification Groups, The Bio-Process Systems Alliance (BPSA)

Ken Davis, Member, Biophorum Operations Group (BPOG)

Suppliers and end users from BioPhorum Operations Group (BPOG) and Bio-Process Systems Alliance (BPSA) were assembled to identify challenges in the Single-Use industry. Two areas that were first selected were the supplier change-control management process and the establishment of user requirements for single-use systems. This presentation will be an update on the progress that both teams have made in creating industry best practices for single-use system change notifications and user requirements.

5:00 Case Study: Efficiency Gains Using a Hybrid Disposables/Stainless Steel Manufacturing Process

Tyler Gadoury, Chemical (Process) Engineer, Bristol-Myers Squibb Co.


Buzz Sessions5:35 BuzZ Session A

Join your peers and colleagues for interactive roundtable discussions.

6:20-7:30 Welcome Reception in the Exhibit Hall with Poster Viewing

7:30 Close of Day

TUESDAY, JANUARY 10

8:00 am Conference Registration and Morning Coffee

RISK MITIGATION STRATEGIES FOR SINGLE-USE TECHNOLOGIES

8:30 Chairperson’s Remarks

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

8:35 Implementation Strategies and Challenges for Single-Use at Clinical to Commercial Scale: Integrity Testing, Material Qualification, Handling Risks

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

This talk will focus on those challenges single-use applications currently have and may have in the future of biotech manufacturing processes. Areas of focus will be regulatory challenges for filings, leak testing and large-scale process limitations for SUTs. Strategies for on-boarding new technologies will be discussed as well.

9:05 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 for 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.

9:35 Sponsored Presentation (Opportunity Available)

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

11:00 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 their significant environmental and cost benefits and flexibility over stainless steel bioreactors. Effect of plastics on the bio-manufacturing process is not yet completely understood. A case study on extractables from single-use bioreactors and impact on cell culture performance will be presented.

11:30 Scalability of a Single-Use Bioreactor Platform for Biopharmaceutical Manufacturing

Niket Bubna, Senior Scientist, Process Development, KBI Biopharma

Here we provide an overview of the key differences between single-use and conventional stainless steel bioreactors, and highlight factors that are employed while scaling-up from small-scale glass bioreactors to 2000 L-scale single-use bioreactors. Several case studies focusing on process performance across scales into single-use bioreactors are provided. This analysis confirms that the 2000 L-scale single-use bioreactor system can be robustly employed for biopharmaceutical manufacturing.

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 Conference