2015 BPD Header

Cambridge Healthtech Institute’s 5th Annual
Bioproduction: Scale, Bioreactors & Disposables
Making It Work
August 5-6, 2015
Part of CHI's 7th Annual The Bioprocessing Summit

August 3-7, 2015 | Westin Copley Place Hotel | Boston, Massachusetts


This meeting will look at the bigger picture of bioprocessing while exploring the details of optimizing processes, both from a practical and an engineering viewpoint, particularly bioreactor engineering. Creating models for scaling down and scaling up, as well as disposables, will also be discussed, as will monitoring and analyzing processes in order to reach optimal conditions and productivity. Examining how bioreactors process cells will be addressed, from small operational details to large-scale bioproduction.


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


Wednesday, August 5

7:00am  Registration and Morning Coffee


OPTIMIZING PROCESSES FOR GREATER PRODUCTIVITY

8:05  Chairperson’s Remarks

Eric J. Wallenstein, Ph.D., Associate Principal Scientist, Biologics Manufacturing Science & Commercialization, Merck & Co., Inc.


8:15  OPENING KEYNOTE PRESENTATION:
Planning for the Future: Manufacturing Capacity Versus Demand Uncertainty

Peter F. MoestaPeter F. Moesta, Ph.D., Senior Vice President, Biologics Development & Operations, Bristol Myers Squibb Co.

The rapid advancements in Immuno-Oncology at BMS have created a unique challenge for Development and Manufacturing. In-licensed molecules that were in early development are being accelerated and putting pressure on commercial process development and readiness. Commercial capacity needs to be made available although neither dose nor volumes are defined. The talk will describe the strategy that is being used combining capabilities in process development, capacity expansions, and leveraging a network of CMOs to address both the potential and the risks of a rapidly developing portfolio of new life-saving drugs.

9:00  Fc-Fusions Versus mABs: Opportunities and Limits of Platform Processes

Stefan SchmidtStefan Schmidt, Ph.D., MBA, Vice President, Process Science & Production, Rentschler Biotechnologie GmbH

In theory, Fc-fusion proteins should behave quite comparably to mABs, both in upstream and downstream processes. However, in practice some differences can be observed. Well-established platform processes only rarely and partially match the requirements for Fc-fusion proteins. I will discuss the range of manufacturing possibilities for fusion proteins with regard to platform processes, modular concepts, and fully customized solutions in comparison to conventional antibody production. 

9:30  Challenges in N-1 Perfusion Process Optimization

Weimin LinWeimin Lin, M.D., Process Development Scientist, Biogen Idec, Inc.

Implementing an N-1 perfusion process at large-scale manufacturing can increase capacity and lower manufacturing costs at Biogen Idec. Perfusion N-1 enables high-seed fed-batch production, which can increase manufacturing capacity by increasing volumetric productivity. However, there are significant challenges in N-1 perfusion process development, such as identifying the proper equipment, improving media formulations, developing a platform process, and scaling-up to the manufacturing facility. This talk will focus on media aspects relating to the above challenges.

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

10:45  A Risk-Based Strategy for Implementing Disposables in a Commercial Manufacturing Process

Chad AtwellChad Atwell, M.S., Associate Director, Manufacturing Science and Technology, Genzyme Corporation

A risk assessment strategy is used to plan the implementation of disposables in a commercial protein purification process. The results influence extractable and leachable study design as well as a dual vendor sourcing strategy to ensure business continuity. An overview of the implementation program is reviewed.

11:15  Effects of Antifoam on High Density Perfusion Cultures: A Case Study Using Small-Scale Models

Jonathan Wang, Process Engineer Associate, Late Stage Cell Culture Development, Sanofi

High density bioreactor perfusion processes require antifoaming agents to manage the foam resulting from high gas sparge rates. We have developed a small scale shake flask model to evaluate the impact of antifoam addition and accumulation on cell culture growth and viability. The small scale model is a good predictor of qualitative trends observed in the bioreactor. Small scale and bioreactor data showing the impact of varying antifoam concentrations with and without the presence of additional shear inducing factors will be discussed.

Eppendorf 2015 logo11:45  A High-Yield Single-Use System for Biosimilar Process Development Using Eppendorf Bio-BLU® Single-Use Vessels and the BioFlo® 320 Bioprocess Control Station

Willard_StaceyStacey Willard, Ph.D., Senior Research Scientist, Applications R&D Lab, Eppendorf

Biosimilars are a fast-growing segment of the biopharmaceutical market. Using a CHO cell line expressing a human MAb, we compare three methods of MAb production using the new BioFlo 320 bioprocess control station. The common batch and fed-batch protocols are discussed, as well as an alternating tangential flow filtration perfusion.

Essential Pharmaceuitcals12:00pm Increasing Protein Production with Novel Cell Ess Supplement without Affecting Metabolic Profile

Elhofy_AdamAdam Elhofy, Ph.D., CSO, Essential Pharmaceuticals

Enhancing protein production is a common goal in the biomanufacturing industry. At a concentration of 1% Cell Ess supplement resulted in a 37% increase in productivity. When using the supplement as a feed it resulted in in a 25% increase in yield and an extension of peak protein production. Our results suggest that an increase in protein production may not necessarily require a change in the metabolic state of the cells.

EMD Millipore12:30  Luncheon Presentation:
Ensuring Scalable Performance of Single-Use Bioreactors from Bench to Clinical Scale

Lloyd_Simler_JaniceJanice Lloyd Simler, Ph.D., Global Senior Product Manager, EMD Millipore Corporation

Bioreactor process set points and parameters developed in bench-top bioreactors are used in the large production scale bioreactors. It is therefore crucial that the set points developed at the small scale can be easily transferred to large scale. This presentation will highlight how a detailed understanding of the performance design space of each sized bioreactor can enable the selection of process parameters at each scale that will enable scalable performance across the platform.

1:30 Session Break


SCALING DOWN

1:55  Chairperson’s Remarks

David Kolwyck, MBA, Director, Manufacturing Sciences, Raw Materials, Biogen Idec, Inc.

2:00  Scale-Down Models for Technology Transfer and Process Characterization of an Upstream Cell Culture Process

Eric J. Wallenstein, Ph.D., Associate Principal Scientist, Global Vaccines & Biologics Commercialization, Merck & Co., Inc.


2:30  Applying Scale-Down Models to Resolve Scale-Up Challenges for MAb Production 

Stephen Hsu, MSc., Senior Research Associate II, Gilead Sciences

 A case study is presented that highlights the challenges encountered with a sensitive CHO cell line expressing a therapeutic monoclonal antibody (mAb) that exhibited reduced productivity upon scale translation. Various scale-down model strategies were leveraged to assess the scalability issues and identify several raw materials and process parameters that led to the reduced titer. Process enhancements were made, based on the scale-down models, to enable subsequent successful large-scale production runs.
 

3:00  Small-Scale Model Development & Application for a Commercial Legacy Process


Hunter Malanson
Hunter Malanson, Scientist I, Upstream Development, Alexion Pharmaceuticals

Significant disparities in scale between commercial production and laboratory bench bioreactors were observed for a legacy process. A qualified 5L small scale model was iteratively developed to mimic the commercial production bioreactor’s behavior and metabolic profile. Cell growth, viability, and productivity trends were closely matched while product quality attributes were maintained. This model is now being actively applied for potential changes and process knowledge for this late-stage commercial process.


3:30 Rapid Development of an Inclusion Body Production Process in E. coli Using Automated Mini-Bioreactor System

Matthew Manahan, MSc., Scientist, Bioprocess Development, Merck & Co., Inc.
This work highlights development of an inclusion body fermentation process using the automated mini-bioreactor system (ambr250TM). With this HTPD approach we were able to screen multiple expression plasmids, seven sequence variants, and process parameters to achieve 50% improvement in fermentation productivity with comparable protein purity over the platform approach. The process development is achieved within 4 months with total of 120 batches, before being successfully scaled up to 30-L.
 

4:00 Refreshment Break in the Exhibit Hall with Poster Viewing

 

 

PLENARY SESSION


4:45 PLENARY KEYNOTE PRESENTATION:
Meeting the Needs of Patients with Rare Diseases: Innovation in Product Development

Joanne-BeckJoanne T. Beck, Ph.D., Senior Vice President, Pharmaceutical Development, Shire Pharmaceuticals

At Shire, where the delivery of innovative medicines to patients with rare diseases and other specialty conditions is a fundamental component of the business model, creative solutions are critical to our success. Starting with the transition of drug candidates from discovery research to the clinic, followed by late-phase development and eventually commercial product life-cycle management, scientists and engineers focus on both technology innovation and creative business approaches to deliver high quality therapies to patients while decreasing development timelines and costs.


5:15  INTERACTIVE PANEL DISCUSSION:

 How to Innovate Product Development 

  • Technologies
  • Strategies
  • Cutting Costs
  • Meeting needs
  • Utilizing creativity
  • Lessons Learned
Panelists:
 
Joanne T. Beck, Ph.D., Senior Vice President, Pharmaceutical Development, Shire Pharmaceuticals
Wayne Froland, Ph.D., Associate Vice President, Center for Biopharmaceutical Manufacturing Sciences, Merck Manufacturing Division
Stefan Schmidt, Ph.D., M.B.A., Vice President, Process Science & Production, Rentschler Biotechnologie GmbH
Haripada Maity, Ph.D., Research Advisor, Eli Lilly and Company


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

7:00 End of Day


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

 

Thursday, August 6

8:00am  Registration and Morning Coffee


SCALING UP AND DOWN

8:25 Chairperson’s Remarks

Stefan Schmidt, Ph.D., MBA, Vice President, GMP Operations, Rentschler Biotechnologie GmbH

8:30  Reducing the Biotech Process Information Gap in the 21st Century: ‘Implementing Process Analytical Technologies at the Seed Expansion Stage for Bioprocess Development and Manufacturing of Biologics’ 

Jose VallejosJose R. Vallejos, Ph.D., Scientist I, Manufacturing Sciences and Technology (MS&T), AstraZeneca/Medimmune 

Manufacturing of Biologics at the seed expansion stage can be further optimized. Utilizing optical patch-based sensors as Process Analytical Technologies (PAT), we were able to enhance the inoculum expansion stage by enabling T-flasks with Dissolved Oxygen and pH sensors. Our results show the potential of implementing PAT at the inoculum expansion stage to improve process understanding and to speed up process development, tech transfer and process improvement timelines. 


 9:00  Points to Consider When Scaling Up Raw Materials in Your Manufacturing Process 

David Kolwyck, MBA, Director, Manufacturing Sciences, Raw Materials, Biogen Idec, Inc.

This presentation will review technical issues that can arise during the quantitative scale-up of raw materials due to changes in manufacturing scale or supplier sourcing of those raw materials. It is intended to provide guidance on technical issues to consider and discuss with suppliers during the scale-up of raw material demand to ensure consistent performance from pilot to large manufacturing.

9:30  Case Studies for Utilization of Conventional and CFD Approaches for Successful Scale-Up and Scale-Down of Bioreactor Processes for Monoclonal Antibodies

Michelle LaFondMichelle LaFond, Director, Bioreactor Scale-Up and Development, Regeneron Pharmaceuticals

Use of both conventional and computational fluid dynamic approaches to develop scale-down, pilot-scale models of production bioreactors have resulted in improved process understanding and more successful transfer for late stage processes. The new scale-down models are more predictive of manufacturing and are used to map out impact of scale-up parameters and bioreactor type to process performance. Case studies of our approach to scale-up will be discussed.

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


BIOPRODUCTION STRATEGIES

10:45  Development of a Novel Feeding Strategy for an Industrial Yeast Strain

Simona_CaponeSimona Capone, Project Assistant, Chemical Engineering, Vienna University of Technology

I will present a bioprocess development strategy based on dynamics for an industrial yeast strain, which is induced under de-repressing conditions. A developed novel mixed-feed strategy gave 3 times higher space time yields than conventional feeding regimes.

 

11:15  HCCF Air Sparging for Prevention of Antibody Disulfide Bond Reduction

Melissa Mun, Senior Engineer, Genentech, Inc. - A Member of the Roche Group

In CHO cell culture processing, mechanical shear during the harvest operations and subsequent release of intracellular factors may result in antibody disulfide bond reduction. Maintaining the harvested cell culture fluid (HCCF) dissolved oxygen level via air sparging is an effective strategy to prevent disulfide reduction.  Small-scale studies were performed to evaluate multiple HCCF air sparging strategies with respect to effectiveness and product quality impact, and to improve understanding of reaction kinetics and oxygen consumption rates.

11:45  Effect of Microspargers on Product Quality Variability in Large-Scale Perfusion Bioreactors

Nirel RilleraNirel Rillera, Research Associate II, BioMarin Pharmaceuticals, Inc.

Multivariate analysis on commercial processes suggested a relationship between superficial gas velocities and cell death, which coincided with variability in product quality attributes. In order to better control product quality, microsparger design was optimized for lower superficial gas velocities and reduced fouling susceptibility. After implementation at commercial scale, the new microspargers were successful in addressing fouling events and improved product quality control.

12:15pm  Sponsored Presentation (Opportunity Available)

12:30  Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:15  Close of Conference


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