January 18-22, 2016 | Town and Country Resort Hotel | SAN DIEGO, CA 
January 18-22, 2016 | Town and Country Resort Hotel | SAN DIEGO, CA 

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Cambridge Healthtech Institute’s 3rd Annual
Single-Use Technologies and Continuous Processing
Advancing Bioprocessing through Technological Innovation
January 18-19, 2016


While single-use technologies and continuous processing (CP) are still fairly new, their steady increase in popularity and successful adoption for both clinical and commercial manufacture are now highlighting several benefits that make these complementary approaches very attractive options within the biopharma industry. The significant advantages of reduced cost of operation, increased productivity, improved quality and increased flexibility of implementing single-use and continuous processing are currently being met by concerns over the added complexity and process control challenges, contamination risks, scalability and regulatory barriers. While some early adopters have fully integrated these systems, others have taken a more measured approach in retrofitting existing batch purification upstream with continuous or single-use components – creating hybrid systems. As the rate of adoption to fully integrate or create hybrid approaches is poised to increase over the next few years, there is great need to evaluate the risks, challenges, opportunities and strategies for implementing these types of technologies into modern day bioprocessing.

Cambridge Healthtech Institute’s 3rd Annual Single-Use Technologies and Continuous Processing conference once again gathers 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.

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Final Agenda

SUNDAY, JANUARY 17


4:00-5:30 pm Registration

5:00-8:00 Dinner Short Courses


MONDAY, JANUARY 18

7:30 am Conference Registration and Morning Coffee


The Future of Bioprecessing:
Disposable and Continuous Processing

9:00 Chairperson’s Opening Remarks

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


KEYNOTE PRESENTATIONS

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

Wolfgang 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. This presentation 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.

10:20 Coffee Break


STANDARDS AND RECOMMENDATIONS FOR SINGLE-USE EQUIPMENT AND PROCESS

10:45 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.

11:15 BPOG and BPSA User Requirements for Single-Use Systems

Zhaoli Zhou, Ph.D., Manager and Senior Engineer, Process Technology Group, Manufacturing Technology, Sanofi Pasteur

BPOG and BPSA single-use system user requirement joint team consists of three major sections including pre-evaluation of single-use systems, quality system requirements and product specification requirements. The joint team is currently working to establish common understanding between suppliers and end users on quality audit guide, internal/external quality release procedure and also regulatory expectations. This presentation summarizes the progress of the user requirement work stream including the whitepaper guidance from each section.

11:45 Vendor Change Notifications for Single-Use Systems

Jeff Carter, Ph.D., Manager, Product Strategy, ReadyToProcess Product Line, GE Healthcare

As single-use system end users, biopharmaceutical manufacturers need to have rigorous change management pro-cedures to ensure these products have consistent quality and performance for their intended applications. This talk presents major activities of the BPOG and BPSA joint team for single-use system change notifications. The goal is to align the requirements, share responsibilities and develop best practices to address key issues related to vendor change notifications.

12:15 pm Streamlined Bioprocess Definition Using a
Novel Laboratory Focused on Automated Hardware,
PAT and Data Harmonization

Jeffery Breit, Ph.D., Director, Biologic Technologies,
Bend Research, a division of Capsugel

Bend Research has built a new laboratory that enables rapid data production and knowledge generation in order to better understand processes that impact productivity and protein quality. The lab incorporates fed batch and perfusion bioreactors with a modular automated sampling technology (MAST™) that shuttles samples to in-line and on-line analytical tools, as well as sample retention hardware. These capabilities enable the generation of robust and high-density datasets that can be used to develop statistical modeling tools to understand and control bioreactor processes better than traditional “once-a-day” sampling experiments.

12:45 Session Break

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


RISK MITIGATION STRATEGIES FOR SINGLE-USE TECHNOLOGIES

2:00 Chairperson’s Remarks

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

2:05 Extractables from Single-Use Bioreactors and Impact on Cell Culture Performance

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

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 its 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.

2:35 Extractable Study Design and Data Evaluation of Polymeric Product Materials

Ping 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 safety and quality perspective. The lack of relevant E&L data from suppliers presents end-users a great challenge. Strategies of developing relevant extractable data and applying that in the evaluation of safety concern threshold level will be discussed.

3:05 Homogenizing Biopharmaceutical Drug Substance Bulk Using Single-Use Mixing Systems

Benson Gikanga, Senior Research Associate, Pharmaceutical Processing and Technology Development, Genentech, Inc.

Depending on mixer design, shearing of biopharmaceutical formulations may be observed. The shearing may generate elevated amount of subvisible particles in the DS solution which in turn may lead to filter fouling during filtration through a 0.22-µm pore size filter. Newer and advanced technologies incorporated in single-use mixing systems may help overcome this challenge. Impact on product quality and process performance following homogenization with various bottom-mounted single-use mixers will be presented.

3:35 Sponsored Presentation (Opportunity Available)

3:50 Refreshment Break in the Exhibit Hall with Poster Viewing

4:30 A Single-Use Strategy to Enable Manufacturing of Affordable Biologics

Renaud Jacquemart, Ph.D., Principal Scientist, Process Sciences, Natrix Separations

Single-use technologies and continuous upstream processes have proven to be cost-efficient options to increase biomass production but as of today the adoption has been only minimal for the purification operations, partly in reason of scale-up and costs concerns. This case study summarizes how a single-use strategy including a holistic process approach, continuous operation, full utilization of media life and high throughput chromatography can overcome scale limitations and enable cost-efficient manufacturing.

5:00 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, Inc.

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.


5:45 BuzZ Session A

Join your peers and colleagues for interactive roundtable discussions.


6:30-7:45 Welcome Reception in the Exhibit Hall with Poster Viewing

7:45 Close of Day

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TUESDAY, JANUARY 19

7:45 am Conference Registration and Morning Coffee


CONTINUOUS PROCESSING: ADVANCES, IMPLEMENTATION AND ENABLING TECHNOLOGIES

8:30 Chairperson’s Remarks

Jay Stout, Ph.D., Executive Director, Center for Biopharmaceutical Manufacturing Sciences, Merck

8:35 Continuous Processing – Rewrite of the Rules?

Jay Stout, Ph.D., Executive Director, Center for Biopharmaceutical Manufacturing Sciences, Merck

9:05 End-to-End Integrated Fully Continuous Production of Recombinant Monoclonal Antibodies

Michael Coolbaugh, Ph.D., Staff Scientist, Late Stage Purification Process Development, Genzyme

This work represents the first demonstration of feasibility for end-to-end continuous bioprocess for biologics. The study shows significant process train simplification, uninterrupted and fully automated purification to the DS over an extended period of time, steady state operation with respect to process flows and product quality. No change with time in the quantities held up in the unit operations. This work serves as a starting point towards achieving highly efficient, universal, end-to-end, fully continuous bio-manufacturing platform.

9:35 Sponsored Presentation (Opportunity Available)

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

11:00 Flexible Facility Designs Complimenting Continuous Processing - Examples and Cases

Maik Jornitz, Founder and Principal Consultant, BioProcess Resources LLC; Vice Chair, Marketing Advisory Board, PDA

Continuous processing and single-use technologies create a processing environment and volume range, which allow such processes to be more compact and flexible. The flexibility of these processes is though hindered by inflexible cleanroom environments and facilities. That trend is changing and innovative facility designs start supporting the processing flexibilities.

11:30 Development of a Perfusion System in a Microbioreactor Using Sedimentation as a Scale Down Tool for ATF Perfusion Bioreactors

Steffen Kreye, Scientist, Upstream Process Development, Glycotope GmbH

With the biotech industry moving to continuous bioprocessing and focusing increasingly on product quality, perfusion bioreactors are becoming more and more important. Here, we demonstrate the development of a sedimentation based perfusion system in the single-use ambr system with good comparability to 1 L ATF perfusion bioreactors when comparing cell growth, viability and product quality, especially glycosylation, for GlycoExpress (GEX) and CHO cells. The system is better suited for clone screening, media optimization and the prediction of qualitly.

12:00 pm Sponsored Presentation (Opportunity Available)

12:30 Session Break

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

1:45 Close of Conference



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