The Bioprocessing Summit

Cambridge Healthtech Institute’s 10th Annual
Optimizing Cell Culture Technology
Enhancing Knowledge for Growing Cells
Part of CHI's 6th Annual The Bioprocessing Summit

August 18-19, 2014 | Renaissance Waterfront Hotel | Boston, Massachusetts


This leading cell culture meeting explores today’s evolving strategies and technologies for improving mammalian cell cultivation, including the omic sciences, such as metabolomics and genomics.  Industry experts offer insights into optimizing conditions as well as cell biology in an effort to improve yield, while also addressing where cell culture is heading as it meets ever greater production demands and quality standards.

The agenda again features a session focused on CHO (Chinese Hamster Ovary cells), as well as small-group breakout discussions that provide the opportunity to discuss important topics with your peers from around the world.


Day 1 | Day 2 | Short Courses | Download Brochure | Speaker Bios 


Monday, August 18

8:00 am Pre-Conference Registration and Morning Coffee


Suggested Short Course*:

9:00-11:30 Short Course*: Optimizing Media - Achieving Super Soup 


*Separate registration required


 

11:30 Main Conference Registration


PROCESS IMPROVEMENT STRATEGIES

1:00 pm Chairperson’s Opening Remarks

Lada LaenenLada Laenen, Ph.D., Head, Cell Culture and Microbiology, MSAT, Genzyme, a Sanofi Company






1:10 OPENING KEYNOTE PRESENTATION:

The Future of Cell Culture Technology

Bert FrohlichBert Frohlich, Ph.D., Director, Bioengineering, Shire Human Genetic Therapies

This talk will begin with a brief overview of factors influencing the direction of cell culture technology and those shaping the biopharmaceutical industry. The overview will serve to tie together many of the subjects covered in this conference. Emphasis will then shift to large-scale production of recombinant proteins and the increasing need for control of product quality and consistency. Emerging technologies, quality-by-design and tools for optimization and achieving improved process understanding will also be touched upon.


1:45 A Statistical Approach to Enhance Productivity in Cell Culture Fed Batch Processes

Hanuman MallubhotlaHanuman Mallubhotla, Ph.D., Research Director and Head, Biopharmaceutical Development, Syngene International, Ltd.

A Design-of-Experiments (DoE) methodology was developed in deriving optimal basal media, feed media and process parameter settings for a cell culture process. Fifteen basal media and seven feed media were screened; feed rate and temperature conditions were optimized based on statistically observed interaction profiles as well as amino acid profiles. Through optimized feed rate and biphasic-temperature culture conditions, the titer was increased by > 6.0-fold from ~ 0.5g/L in shake flasks to > 3.0 g/L in bioreactors.

2:15 The Application of Systems Biology in Bioprocess Optimization

Len van ZylLen van Zyl, Ph.D., CEO and CSO, ArrayXpress, Inc.

The integration of a Systems Biology approach to optimize and speed-up upstream and downstream bioprocesses is gaining significant traction in the biopharmaceutical industry. Improving our understanding of the cells, the actual bioreactors themselves, provides for a beginning to end development approach to improve product quality and performance. Systems biology as a concept aims to map all conceivable interactions within a system through a set of measurable variables.

2:45 Refreshment Break


OPTIMIZING CELL CULTURE PROCESSES FOR ANTIBODY PRODUCTION

3:15 Antibody Screening in Mammalian Suspension Cells

Michael R. DysonMichael R. Dyson, Ph.D., Senior Research Associate, Biochemistry, University of Cambridge, and Group Leader, IONTAS, Ltd.

An important step in the process of recombinant antibody selection and optimisation by phage display is the conversion to IgG and Fab format and multi-parallel expression in mammalian suspension cells. This is to both select for clones that can be expressed in high yield and provide antibodies for cell-based functional assays. Methods will be presented for high-throughput antibody expression in HEK293, CHO and stem cells including case studies for the selection of functionally active antibodies.

3:45 Modulation of the Quality Attributes of a Monoclonal Antibody Using Micro-L Scale Fed-Batch Cultures

Martin JordanMartin Jordan, Ph.D., Scientist, Biotech Process Sciences, Merck Serono SA

A high-throughput DoE approach was used to explore the impact of media and feed components on the main quality attributes of a monoclonal antibody. The experiment was performed using a new cultivation system based on shaking 96-deepwell plates. This integrated early cell culture process development approach was found to be particularly fast and resource efficient and the outcome correlated ideally with confirmations performed in larger cell culture volumes such as shake tubes and small-scale bioreactors.

4:15 Small Group Breakout Discussions

This session provides the opportunity to discuss a focused topic with peers from around the world in an open, collegial setting. Select from the list of topics available and join the moderated discussion to share ideas, gain insights, establish collaborations or commiserate about persistent challenges. Then continue the discussion as you head into the lively exhibit hall for information about the latest technologies.

Optimal Raw Materials and Supplier Selection

Moderator: Sofie Goetschalckx, Head, Cell Culture Manufacturing Science Team, MSAT, Cell Culture and Microbiology, Genzyme, A Sanofi Company

Raw materials used in biopharmaceutical products are critical. Control of raw materials is essential to maintaining safety and to ensure lot-to-lot consistency. Raw materials quality management starts with identifying all raw materials and assessing their criticality to product safety, efficacy and supply.

  • Challenges in ensuring highest quality for selected raw materials
  • How to release critical (custom made) raw materials
  • How to deal with change notification
  • Biosafety risk mitigation

The Tool Kit for Cell Line Development and Characterization

Moderator: Yung-shyeng Tsao, Ph.D., Senior Principal Scientist, BioProcess Technology and Expression, Biologics Bioprocess Development, Merck & Co.

  • What tools are available
  • Pros and cons
  • New technologies

Scale-Up/Scale-Down Systems/Studies

Moderator: Jeffrey Chalmers, Ph.D., Professor, Chemical and Biomolecular Engineering, Director, Analytical Cytometry Shared Resource, Comprehensive Cancer Center, The Ohio State University

  • Current methods
  • QbD questions

Screening for the Optimal Antibody Development Candidate Outline Profile (DCOP)

Moderator: Michael R. Dyson, Ph.D., Senior Research Associate, Biochemistry, University of Cambridge, and Group Leader, IONTAS, Ltd.

During an antibody screening campaign many variants are screened for the optimal DCOP. Properties to be examined include functional activity, affinity for its target, specificity, species cross-reactivity, solubility and stability. Topics for discussion will include:

  • What is the best expression system for multiplexed antibody screening? Considerations for discussion include speed, throughput and antibody format.
  • What is the most efficient affinity ranking cascade?
  • Can expression yield or antibody sequence predict solubility?
  • Is it possible to devise a high throughput antibody solubility assay to both screen multiple clones and buffer conditions?

Steps to Accomplishing Next-Generation Bioprocessing

Moderator: Len van Zyl, Ph.D., CEO and CSO, ArrayXpress Inc.

  • Determining your key objectives: predictability, consistency, increased titers and higher quality
  • Deciding on the best tools for Systems Biology: current state and future directions
  • Strategies to implement genome and metabolic engineering
  • Selling the business case for Systems Biology Engineering

Impact of Transient Transfection on Development Timelines

Moderator: James Brady, Ph.D., Director, Technical Applications, MaxCyte, Inc.

  • From Transient Transfection to Stable Pools and Stable Clones
  • Shorten Development Timelines via Large-Scale Transient Transfection in CHO Cells
  • Gram-level antibody production
 

5:15 Discussion Report-Outs  

5:30 Grand Opening Reception in the Exhibit Hall with Poster Viewing

7:00 End of Day



Day 1 | Day 2 | Short Courses | Download Brochure | Speaker Bios