The Bioprocessing Summit
The Bioprocessing Summit

Cambridge Healthtech Institute’s 3rd Annual
Cell Therapy Bioproduction, Operations and Logistics
Industrializing Cell Therapy Production
Part of CHI's 8th Annual The Bioprocessing Summit

August 17-18, 2016 | Westin Boston Waterfront | Boston, MA


The clinical results are beyond encouraging. Now the pressure is on manufacturing, operations and development teams to develop the scalable, robust manufacturing platforms needed to bring these therapies – most noticeably CAR-Ts - to patients.

CHI’s Cell Therapy BioProduction, Operations and Logistics conference takes a practical, case study driven approach to industrializing cell therapies, from scaling up to scaling-out, automation to closed system, with particular attention paid to CAR-T manufacturing and companies willing to share data, experiences and challenges in the run up to commercial launch.

Final Agenda

Day 1 | Day 2 | Short Courses | Download Brochure


Wednesday, August 17

7:00 am Registration Opens and Morning Coffee


PREPARING FOR LATE-STAGE CELL THERAPY MANUFACTURING

8:05 Chairperson’s Opening Remarks

Ohad Karnieli, Ph.D., Chair, Process and Product Development committee, (ISCT) and CEO of Karnieli Ltd


8:15 KEYNOTE PRESENTATION:
Applying Concepts of mAb and Vaccine Manufacturing to Cellular Immune Therapy

Alain_PralongAlain Pralong, Ph.D., Senior Vice President, Manufacturing Operations, CellMedica

Massive evolution in cellular immune therapies for treatment of cancers has taken place over the last decade. A significant number of new companies has been created. Some have gained massive value through promising therapeutic approaches. Manufacturing and GMP compliance has not reached the maturity level of mAb and Vaccine manufacturing. How can proven concept be implemented in cellular immune therapy?


9:00 Successful Cell Therapy Manufacturing: Think Big!

Knut_Niss Knut Niss, Ph.D., Asset Leader Cell Therapies, Director, PO&T, Biogen

Close logistical coordination is required from obtaining the starting material to delivering the product (“bedside to bedside” or “arm-to-arm”). While these challenges can be managed in early clinical trials through close interaction between the manufacturing organization and the clinical site, commercial needs require a focus on cost effective operations. Thus, to reach a commercially successful cell therapy, logistical challenges in combination with processing technologies need to be evaluated.



9:30 Panel Discussion: Considerations for Commericial-Scale Manufacturing

Participants:

Alain Pralong, Ph.D., Senior Vice President, Manufacturing Operations, CellMedica

Knut Niss, Ph.D., Asset Leader Cell Therapies, Director, PO&T, Biogen

Bo Kara, Head, Process Development, Cell Gene Therapy, Platform CMC, GSK


10:00 Coffee Break in the Exhibit Hall with Poster Viewing


SCALE-UP & SCALE-OUT STRATEGIES TO REDUCE COST OF GOODS

10:45 Gene/Cell therapies Production Scale-up Through Modular Incubation Systems

Robert_DreamRobert Dream, PE, CPIP, Managing Director, HDR Company, LLC

 

11:15 Scale-Up Strategies and Process Optimisation for Cell Therapies

Ravinder_BhatiaRavinder Bhatia, Ph.D., Director, Pharmaceutical Development and Manufacturing Sciences, Johnson & Johnson

In this presentation, a case study will be presented on the considerations to select technologies to develop a robust, and scalable process for allogeneic cell therapy products.  Also,  a control strategy based on QbD principles to consistently meet product quality by controlling the raw materials attributes and process parameters will be discussed.


11:45 Sponsored Presentations (Opportunities Available)

12:15 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own

1:00 Session Break


AUTOMATION, NEW TECHNOLOGIES & WORKING WITHIN CLOSED SYSTEMS

1:45 Chairperson’s Remarks

Ohad Karnieli, Ph.D., Chair, Process and Product Development Committee, (ISCT) and CEO of Karnieli Ltd.

1:50 New Technologies Driving A Closed System Manufacturing Process

Ohad_KarnieliOhad Karnieli, Ph.D., Chair, Process and Product Development committee, (ISCT) and CEO of Karnieli Ltd.

As cell therapy matures moving form bed side to clinic, the need for automated closed system manufacturing technologies become critical to insure quality, availability and cost efficiency of the treatments. This need enhances dramatically in cases of autologous therapies. The talk will describe case studies of process development work and present available and new technologies for closed and automated cell culturing systems.

2:20 The Pros and Cons of Using Automated Closed Systems for Cell Therapy Trials

Barbara_SeymourBarbara Seymour, MBA, Senior Director, Manufacturing, Unum Therapeutics

Manufacturing autologous cell therapies in automated closed systems may become industry standard, but many challenges can manifest when adapting a process to a system or vice versa. Labor savings and microbial reduction may be offset by extended time in development to confirm process robustness or the effects of any change. Understanding system limitations, staffing, costs and potential business continuity is essential for good clinical programs.

2:50 Transportating and Tracking Cell Therapies across Sites

Adrian_GeeProfessor Adrian Gee, Ph.D., Center for Cell & Gene Therapy, Baylor College of Medicine

As cellular therapies move towards licensure centralized manufacturing is inevitable. This necessitates development of optimal methods for shipping starting cells and final products. Recent evidence suggests that functionality of some cells is impaired by cryopreservation and that transportation of fresh cultures is preferable. In parallel, systems must be developed for tracking and tracing cells from the time of collection to patient administration.

3:20 Deviation Prevention, Reduction, Training, and Error Prevention to Ensure These Therapies Are Produced Safely and Consistently

Gary_du_MoulinGary du Moulin, Ph.D., MPH, RAC, Associate Professor, Massachusetts College of Pharmacy and Health Sciences University

Errors committed during production steps or during quality control testing continue to be a major concern in this growing industry. This presentation describes how an understanding of human factors and causality of errors can minimize deviations. Improvements in training approaches can lead to a goal of zero defects in cell therapy manufacturing operations. The importance of leadership and inculcating a culture of quality will also be emphasized in building robust quality systems.

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


4:45 Plenary Keynote Session - click here for details


6:00 Networking Reception in the Exhibit Hall with Poster Viewing

7:00 End of Day


Day 1 | Day 2 | Short Courses | Download Brochure


Thursday, August 18

8:00 am Registration Opens and Morning Coffee


CAR-T MANUFACTURING STRATEGIES

8:25 Chairperson’s Remarks

Ohad Karnieli, Ph.D., Chair, Process and Product Development Committee, (ISCT) and CEO of Karnieli Ltd.

8:30 Commercialization of ex vivo Cell and Gene Therapy Products: Establishing Processes, Manufacturing and Supply Chains

Bo_KaraBo Kara, Head, Process Development, Cell Gene Therapy, Platform CMC, GSK

The complexities of the CGT supply chain requires cost sensitivity analysis driven process development for cost efficient delivery of plasmid DNA’s, vector manufacturing and cell processing. This presentation will discuss the technology and process development challenges in the delivery of ex-vivo cell gene therapy medicines and describe approaches to scale-up and commercialization.

9:00 Developing a Scalable, Robust and Cost-Effective CAR-T Process

Dawn_MaierDawn Maier, Senior Manager, Cellular Process Development and Manufacturing, bluebird bio Inc.

Adoptive transfer of autologous T cells genetically engineered to express chimeric antigen receptors (CARs) has emerged as a promising approach for the treatment of cancer. However, to fully realize the therapeutic potential of these engineered T cells, simple and robust manufacturing processes that decrease time and cost are required. A summary of the data to support bluebird bio’s approach and clinical platform will be presented.

 Flo-Design Sonics9:30 Novel Acoustic Technology for Cell Processing: Concentration/Wash

Chris Leidel, Vice President, Business Development, FloDesign Sonics

FloDesign Sonics has developed an acoustic platform that can be used for a variety of cell processing applications. The technology can be designed in to automated, closed, and scalable systems that provide unique advantages during cell manipulations. This talk will present an explanation of the technology and early performance data.

10:00 Coffee Break in the Exhibit Hall with Poster Viewing


OFF-THE-SHELF/ OFF-SITE CAR-T MANUFACTURING

10:45 Manufacturing Cellectis’ Allogeneic UCART Product Candidates

Sylvain_ArnouldSylvain Arnould, Head, Manufacturing, Cellectis

At Cellectis, we are manufacturing allogeneic off-the-shelf UCART-cell product candidates. The specificity of those allogeneic therapies is that T-cells from healthy donors are genetically edited with our proprietary technology TALEN®. This approach could lead to a cost-effective drug, easily distributed across all geographies and available to cancer patients.

11:15 Off-Site Manufacturing Challenges when Dealing with CAR-T Cells

Sean_SmithSean Smith, Ph.D., Cell Processing Specialist, Dana-Farber Cancer Institute

Off site manufacturing is a viable option for some companies producing cell therapies, but like any other process, it has its pros and cons. New start up companies. New ideas. Both are a important parts of an ever changing biotech landscape. But sometimes these new companies are not equipped, or just cannot afford to pursue these ideas. They have great ideas, but need some help. Sometimes a more established institution with a trained staff is needed. This is where off-site manufacturing comes in.

11:45 Cellular immunotherapy: Product, Process and Patents

David_BrindleyDavid Brindley, Ph.D., Cooksey-Botnar-Saïd Fellow, Saïd Business School/Paediatrics, University of Oxford

CAR-T immunotherapy efficacy is building, however certain critical aspects of manufacturing processes remain largely unexplored, notably the impact of leachables and extractables. Combined with a complex patent landscape and a shift away from patenting the therapeutic entity towards patents of processes and components, a number of pertinent challenges for both academia and industry exist.

12:15 Lunch Available for Purchase in the Exhibit Hall

1:15 Dessert Refreshment Break in the Exhibit Hall with Poster Viewing

1:55 End of Conference



Day 1 | Day 2 | Short Courses | Download Brochure