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Cambridge Healthtech Institute’s 2nd Annual
Single-Use Technologies and Continuous Processing
Driving Value Through Process Innovations
January 19-20, 2015


Single-use technologies and continuous processing are the two key drivers in the bioprocessing industry today. Although each can be implemented on its own, the combination of single-use with continuous processing promises to bring even greater flexibility and productivity gains. CHI’s Second Annual Single-Use Technologies and Continuous Processing conference highlights the risks, challenges, opportunities and strategies for implementing these two separate yet complementary technologies, and showcases how companies can drive value and increase productivity through these innovations.


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Final Agenda 


SUNDAY, JANUARY 18


4:00-5:00 pm Short Course Registration

5:00-8:00 Pre-Conference Dinner Short Courses More Details >> 


4:00-8:00 Main Conference Registration


MONDAY, JANUARY 19

7:30 am Conference Registration and Morning Coffee

9:00 Chairperson’s Opening Remarks

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


Keynote Presentations

9:10 Driving Value through Manufacturing: Innovation in a Hybrid Biologics Manufacturing Network

Jorg ThommesJorg Thommes, Ph.D., Vice President, Operations, Technology & Innovation, Biogen Idec

Has the time come for disruptive innovation or will continued sustaining innovation be sufficient for the challenges of a changing industrial environment? To answer this question, we discuss Biogen Idec’s approach to a hybrid network of biologics manufacturing facilities. We also discuss a few opportunities for innovation within existing technologies and also share a few thoughts on continuous manufacturing as an alternate route to maximize productivity.

9:50 Towards Biomanufacturing on Demand

Chris LoveChristopher Love, Ph.D., Professor, Chemical Engineering, MIT

The delivery of biologic drugs to patients can be challenging in many regions of the world. Patients may live in remote regions, under-resourced areas, or face challenging circumstances such as natural disasters. The state-of-the-art approaches to manufacture biopharmaceuticals are not compatible with on-site, rapid manufacturing of treatments on demand. This talk will present Integrated and Scalable Cyto-Technology (InSCyT) as a platform for continuous, mobile production in a closed-system facility that includes PAT and QbD.


10:20 Coffee Break


Risk Mitigation Strategies for Single-Use Technologies

10:45 A Lifecycle Approach to Management of Leachables & Extractables Related Risk in Processes with Significant Investment in Single Use Components

Naveen_PathakNaveen Pathak, MSc, Director, MS&T, Process Development & Manufacturing Science, Shire

Determination of cumulative risk under worst-case and likely-case scenarios will be demonstrated to be an important first step to establish the baseline safety profile of the process. A risk based approach to evaluate subsequent addition of new single use components will be discussed. The L&E data will be used to support creation of a library of well characterized single-use components that will support efficient new product introductions.

11:15 Extractables and Leachables from Single-Use Components - Can They Be Cleared through Ultrafiltration/Diafiltration (UF/DF) Process?

Kate_LeeKate Lee, Ph.D., Process Development Engineer, Genentech, Inc.

Studies were performed to quantify the clearance of common small molecules that are extracted or leached from single-use components in the unit operations upstream of the ultrafiltration/diafiltration (UF/DF) step by UF/DF process. Results from the study indicated clearance of defined extractbles/leachables in protein solutions. However, unexpected clearance phenomena were observed for specific groups of extractbles/leachables, which will be discussed.

 

11:45 Advances in Next Generation Manufacturing

Robert Dream, PE, CPIP, CPMP, Ph.D., Principal, HDR Company Ltd.  

 

12:15 pm Single-Use Bag Extractable Case Study: Lessons Learned

Mike_JohnsonMike Johnson, Global Bioprocess Applications Manager, Entegris, Inc.

A supplier’s ability to furnish extractable data to end users is of extreme importance. The protocols followed to produce such data are currently a point of discussion between suppliers and end users. In this case study, single-use bags were subjected to a portion of the BioPhorum Operations Group (BPOG) extractable protocol. This presentation documents the testing process, lessons learned, along with sample extractable data and trends from a supplier’s perspective.

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 processes

2:00 Chairperson’s Remarks

James Dean Vogel, P.E., Founder & Director, The Bioprocess Institute and Chair, BPSA Particulates Workgroup

2:05 Implementation Strategies and Challenges for Single-Use at Clinical to Commercial Scale: Integrity Testing, Material Qualification, Handling Risks

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

This talk will review areas that should be considered with respect to disposable implementation. Understanding industry standards, quality and manufacturing needs for use in commercial applications, standardization of designs, as well as handling risks at full scale will be discussed. This presentation will outline key issues and how industry associations, suppliers and end users are addressing some of these areas.

2:35 Driving Adoption of Single-Use into cGMP: Reflections of the BPOG End Users Disposable Working Group

David_PollardDavid Pollard, Ph.D., Executive Director, Bioprocess Development, Merck Research Laboratories, Merck & Co., Inc.; Member, BioPhorum Operations Group (BPoG)

Efforts to implement SUT into commercial operations often exposes gaps in expectations between Supplier and End User. Case studies will cover the expectations of key issues for materials, film properties, extractables, sterilization validation, assembly process, change notification and integrity testing. Examples will be presented for achieving a wide and consistent alignment on the support needed for GMP environments, providing the foundation for SUT standards , strengthen collaboration between end users and suppliers and improve SUT implementation.

 

3:05 BPSA Update Part 1: Recommendations for Testing, Evaluation and Control of Particulates from Single-Use Process Equipment 

James Dean VogelJames Dean Vogel, P.E., Founder & Director, The Bioprocess Institute and Chair, BPSA Particulates Workgroup

This paper and documents serve two purposes: to serve as a guide to characterization and determination of levels and types of particles in SUTs as well as to recommend procedures to achieve minimal levels of particles in SUT.

 

3:25 BPSA Update Part 2: Industry Initiatives to Standardized Single Use Manufacturing – Extractables, Quality Agreements, System Designs

Jerold MartinJerold Martin, MSc, Chairman, Technology Committee, BPSA

This presentation describes how suppliers and users are working together to establish standardized practices including component extractables testing and data reporting, quality agreements and system designs.

 

 

3:50 Refreshment Break 


RISK-BENEFIT ANALYSIS AND
PROCESSING CHALLENGES

4:15 Can Continuous Processing and Single-Use Benefit Vaccine Manufacturing?

Ronald_NeelemanRonald Neeleman, Ph.D., Senior Director, Vaccine Innovation and Virology Expert, Global Technology Innovation, Sanofi Pasteur

Vaccine manufacturing has a long history and a great variety (attenuated, inactivated, subunits, conjugations, etc.) but the production methods have remained batch in stainless steel. This presentation will deal with the key drivers to move from batch to continuous processing in single-use systems. Based on examples and experience of Sanofi Pasteur, the technical, scientific, and business motivations will be addressed.

4:45 Continuous Upstream Processing – Single-Use Versus Standard Technologies

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

Continuous processing for the production of biologics from mammalian cell culture is developing into a viable alternative to the standard fed-batch fermentation. One of the main advantages is to reduce the necessary equipment size so that production can be done in simple lab-like manufacturing infrastructure using disposable instead of hard-piped equipment. This talk will describe advantages and disadvantages of continuous upstream processing in general and will compare single-use with standard, non-single-use based set-ups.

5:15 Mitigating Scale-Up and Process Challenges for Microbial Fermentation in Single-Use Production Vessels

Rajesh Krishnan, Ph.D., Director, BioProcess Development, Gilead Sciences

ProteinSimple Large

5:45-7:00 Welcome Reception in the Exhibit Hall with Poster Viewing



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