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Scaling Up & Down With Optimized Bioreactors + Disposables - Day 1


Scaling Up & Down with Optimized Bioreactors + Disposables 

This meeting addresses developing representative scale-down models of large-scale processes that facilitate implementation of Quality by Design (QbD), process validation, and continuous improvement in order to achieve greater productivity for producing biopharmaceuticals. Besides exploring strategies for scaling production, experts will review ongoing innovations for bioreactor protocols and design, including mini and micro bioreactors.  In addition, case studies from leading biotechs will be presented that examine implementing single-use technologies.
 

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Wednesday, August 24

7:30am Registration & Morning Coffee

 

REPRESENTATIVE SCALE-DOWN MODELS 

8:25 Chairperson's Remarks

Frank Baganz, Ph.D., Senior Lecturer, Biochemical Engineering, University College London

8:30 Opening Keynote Presentation

Use of Scale-Down Models to Investigate Raw Material Impact on Process Performance

Gregg AmgenGregg Nyberg, Ph.D., Director, Process Development, Amgen, Inc.

Successful scale-up and technology transfer requires process understanding, which is typically achieved through process development and characterization performed in small-scale models. Small-scale models are also important for troubleshooting issues encountered during commercial-scale manufacturing. This case study describes how small-scale models were effectively used to troubleshoot manufacturing issues related to raw material variability.

 

9:00 Development and Qualification of a Scale-Down Model for a Commercial Cell Culture Process

 

Bruno Figueroa, Ph.D., Senior Principal Scientist, Bioprocess R&D & Culture Process Development, Pfizer, Inc.

Scale-down models are essential for process characterization and process manufacturing support prior to and during the commercial product life cycle. Development and qualification of a bioreactor scale-down model has become a regulatory expectation. In this case study, we will present how we developed and qualified a scale-down model at 2L scale for a mammalian cell culture process at 12KL scale. Both univariate analysis and multivariate analysis were performed to demonstrate equivalency of cell culture performance and product quality between small scale and commercial scale.

9:30 POSTER HIGHLIGHT I
Development of a 12L Perfusion Bioreactor Cell Culture Scale-Down Model for Commercial Manufacturing Support

Caroline DiCesare, Process Engineer 1, Commercial Cell Culture Development, Genzyme Corp.

10:00 Networking Coffee Break with Exhibit and Poster Viewing

10:45 Scale-Down Model Assessment for QbD Cell Culture Characterization: A Case Study for a Monoclonal Antibody Production Process

Meg TungMeg Tung, Senior Research Associate, Late Stage Cell Culture, Pharma Technical Development, Genentech, Inc.

The goal of using a QbD approach for cell culture process characterization is to gain overall process understanding, with the final outcomes being both univariate and multivariate acceptable ranges for each parameter tested, and a design space which ensures acceptable process performance and product quality. Due to the sheer number of studies required, the use of scale-down models makes such characterization effort possible. However, the applicability of the QbD characterization study results to the full scale depends on the validity of the scale-down models that are used. This case study will present the scale-down model comparison approach and the strategy that is used to allow meaningful translation of the scale-down QbD study results to the full scale.

11:15 Ensuring Predictability for Scale-Up & Scale-Down by Defining an Engineering Design Space

José Gomes, Principal Scientist & Manager, Bioreactor Process Development, Pfizer, Inc.

11:45 POSTER HIGHLIGHT IISmall Scale Cell Culture Models as a Predictive Tool for At-Scale Performance

Lada Laenen, Ph.D., Managing Principal Scientist, Cell Culture and Microbiology, Genzyme Corporation, Belgium

12:00 pm Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own

 

OPTIMIZING Processes with Single-Use Technologies 

1:55 Chairperson's Remarks

Nanda K. Subbarao, Ph.D., Senior Consultant, Biologics Consulting Group, Inc.

2:00 Single-Use Bioreactor Design

David MarksDavid M. Marks, Senior Consultant and President, DME Alliance Incorporated

This presentation will discuss the challenges and key considerations for the design and scale-up of single-use cell culture bioreactors.  A performance comparison with traditional stainless steel bioreactors will be provided, along with a summary of the relative advantages and disadvantages of disposable systems for upstream biologics manufacturing.  Discussion will focus on points to consider when selecting disposable bioreactor technology.

Sponsored by
Thomson Instrument Company 
2:30 Shaken not Stirred - Single Use Optimum Growth 5L Flasks with Data from Insect Cells, CHO, Hybridoma, HEK293 Cell Lines 
Sam A. Ellis, Vice President, Cell Line Development Products, Thomson Instrument Company
Optimum Growth Flasks (patented) give excellent growth with space saving capability. Optimum Growth Flasks users are able to to grow 2.5L/Flask  of Cell Culture,  up to 17.5L per shaker, and 52.5L in a triple stack shaker. The Optimum Growth Flasks allow for more protein, and cell growth in studies versus   Wave® Bags.  Data  will be presented on Insect Cells, CHO, Hybridoma, HEK293 Cell Lines.  

3:00 Key Considerations during the Scale-Up of a Fully Disposable Perfusion Bioreactor System

Jin YinJin Yin, Ph.D., Principal Bioengineer, Cell Culture, Shire Human Genetic Therapies

To support the production of therapeutic proteins, a fully disposable perfusion bioreactor system has been developed. The system consists of a disposable bioreactor and a disposable centrifugation cell retention device, which has been successfully scaled-up to 2000 L scale. Challenges such as mass transfer, mixing, shear stress and centrifuge perfusion capacity during the scale-up of the system will be discussed. The approaches to address these scale-up related challenges will also be presented.
 

3:30 Networking Refreshment Break with Exhibit and Poster Viewing

 

Mini/Micro Bioreactors 

4:15 Rapid Bioprocess Development Using Miniature Bioreactor Technologies

Frank BaganzFrank Baganz, Ph.D., Senior Lecturer, Biochemical Engineering, University College London

The need for greater speed and efficiency during the development of fermentation and cell culture processes has led to the development and application of miniaturised bioreactor technologies. This presentation will focus on shaken microwell-based systems and miniature stirred tank reactors and will cover the engineering characterisation in terms of power input, liquid phase mixing and oxygen mass transfer. Furthermore, examples will be given for the application of these technologies in fermentation and cell culture process development. The application of single-use bioreactor technologies will also discussed.
 

4:45 Successful Scale-Up of Bioprocesses from Shaken 500 µl Microfluidic Micro-Bioreactors with Fed-Batch Operation, pH Control and Full Online Monitoring Capabilities

Jochen BuchsJochen Büchs, Ph.D., Professor and Chair, Biochemical Engineering, Aachen University of Technology

A 500 µL micro-bioreactor system was developed based on the 48 well microtiter plate format. The shape of the wells was designed such that oxygen transfer is enhanced to meet the demand even of fast growing cultures. The ground plate of the micro-bioreactors contains a set of microfluidic valves and pumps. These allow dosing of very small amounts of liquid in the nL-range into the bulk liquid of the shaken micro-bioreactors. Different fed-batch and pH-controlled fermentations were conducted in the 500 µL micro-bioreactor system. Almost the same fermentation kinetics were obtained in 500 µL scale as well as in 1 L scale, demonstrating the usefulness of the developed micro-bioreactor and of the scale-up procedure.

5:15 Networking Reception, Last Chance for Poster and Exhibit Viewing

6:45 End of Day



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