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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.

MONDAY, JANUARY 9

Beryllium7:30 am Conference 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 Jenke, Ph.D., Baxter Distinguished Scientist, Technology Resources, Baxter Healthcare Corp.


Keynote Presentation

9:10 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.

9:50 Creating a Next-Generation Vaccine Facility: Merging High-Productivity Technologies for Robust and Cost-Effective Manufacturing

Benjamin Damien, Business Developer, Univercells

James G. Stout, Ph.D., Vice President, Process Sciences, Natrix Separations

This presentation will focus on a new holistic approach that integrates tested strategies for cost-efficient manufacturing of vaccines, linking innovations in cell culture strategies, bioreactor design, membrane chromatography and flexible facility design for a 500-fold increase in overall productivity. This next-generation facility merging high-productivity technologies to achieve simplified process architecture, increased robustness and augmented yield can be replicated anywhere to make production in developing countries in need of vaccines a reality.

Beryllium10:20 Coffee Break

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

Renaud 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 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 product quality aspects are discussed.

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.

Cell Culture Company12:15 pm Continuous Upstream Biologics Production: Fail Fast, Fail Safe and Fail Cheap

Scott_WanigerScott Waniger, Vice President, Bioservices, Cell Culture Company

Your molecule exceeds bio-activity expectations in bench and animal studies. You need to get to clinical trials fast, but you have challenges. Your molecule does not express well in fed-batch tanks. You cannot afford to develop a high-expressing CHO line. Production timelines are not feasible. Less than 10% of new drugs obtain market approval. Our innovative perfusion GMP platform for CDMO services can bring your difficult-to-express protein to clinical trials fast, safe and cost effectively.

  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.

 

3:20 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

Jayanthi Grebin, Member, User Specification Groups, The Bio-Process Systems Alliance (BPSA)

Trishna Ray Chaudhuri, Member, Biophorum Operations Group (BPOG)

Josh Curry, 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_GadouryTyler Gadoury, Engineer, Manufacturing Technology, Bristol-Myers Squibb Co.

This presentation will analyze the benefits and limitations associated with the implementation of single-use technology at a large-scale, multi-product commercial manufacturing facility. By integrating single-use components into a stainless steel facility, a hybrid equipment approach enhances manufacturing flexibility while enabling an accelerated manufacturing cadence. The case study will discuss the application of single-use systems through examination of cost, supply chain and logistics, manufacturing cycle time reduction efforts, and yield improvements.

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

7:30 Close of Day

TUESDAY, JANUARY 10

Beryllium8:00 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.

9:50 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.

GE Healthcare logo small12:00 Intensified Chromatography Operations through Connected and Continuous Processing

Kristin Lenberg, Global Product Marketing Manager, ÄKTA™ lab-scale systems, Product Management, GE Healthcare
The desire to intensify chromatography operations can be driven by a variety of incentives, and the principles can be applied at different levels and scales where process flexibility is balanced with process intensification. This presentation will demonstrate principles of connected, continuous chromatography, highlighting its benefits and how it can be applied. Case studies for both connected and continuous chromatography processes at different scales will be discussed.

12:30 Session Break

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

1:15 Close of Conference



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