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 


Wednesday, August 5

7:00 am 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. 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 Schmidt, Ph.D., MBA, Vice President, GMP Operations, 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 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 Defining the Boundary Between Process Development and GMP Manufacturing: Starting Up a Manufacturing Science Laboratory

Chad Atwell, MS, Associate Director, Manufacturing Science and Technology, Genzyme Corporation

The start-up of a new manufacturing science laboratory will be reviewed including scale down process model qualifications. Compliance expectations for data generated during continuing commercial process characterization will be compared with FDA PV guidance, USP and ICH requirements. A hybrid approach was defined for the manufacturing science lab.

11:15 Enabling Biopharmaceutical Process Development with Next Generation Technologies

William Napoli, Associate Scientist, Pharmaceutical Process Development, Merck & Co., Inc

11:45 A High-Yield Single-Use System for Biosimilar Process Development Using Eppendorf Bio-BLU® Single-Use Vessels and the BioFlo® 320 Bioprocess Control Station

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

12:00 pm Sponsored Presentation (Opportunity Available)

12:15 Luncheon Presentation: Ensuring Scalable Performance of Single-Use Bioreactors from Bench to Clinical Scale

Janice 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, Biologics Manufacturing Science & Commercialization, Merck & Co., Inc.


2:30 Overcoming Scale-Down Model Development Challenges for MAb Production

Gayle E. Derfus, Ph.D., Senior Research Scientist I, Gilead Sciences

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

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 ambr250 as a Scale-Down Model, Using Both Mammalian and E.coli Expression Systems

Matthew Manahan, Scientist, Bioprocess Development, Merck & Co., Inc.

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

4:45 Plenary Keynote Session

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 6

8:00 am 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 Challenges in Bioreactor Scale-Up and -Down

LiYing Yang, Ph.D., Scientist II, Manufacturing Sciences & Technology, Supply Biologics, AstraZeneca

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

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

Oliver Spadiut, Ph.D., Group Leader, Biochemical Engineering, Bioprocess Technology, 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, Engineer, Genentech, Inc. - A Member of the Roche Group

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

Nirel Rillera, Research Associate, 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.

12:15 pm Sponsored Presentation (Opportunity Available)

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

1:15 Close of Conference


Day 1 | Day 2 | Short Courses | Download Brochure