Cambridge Healthtech Institute’s 3rd Annual
Process Characterization and Control
A best practices forum for the translation of process understanding into control strategies for maintaining quality throughout the product lifecycle
Part of CHI's Ninth Annual The Bioprocessing Summit

August 24-25, 2017 | Westin Copley Place | Boston, MA

With the recent publication of process validation guidances from both US and European regulators, the demonstration of process understanding, identification of critical quality attributes and the implementation of well-validated control strategies must now become a routine part of biologics manufacturing operations. But significant ambiguities remain in the specific steps that must be taken in the production of legacy and new products, by companies of different scale and resources and for specific product formats. The Process Characterization and Control conference offers a forum for the sharing of strategies and best practices from a wide range of industry companies working to implement these complex new standards.

Final Agenda

Thursday, August 24

11:30 am Registration Open

12:15 pm Enjoy Lunch on Your Own

1:15 Dessert Refreshment Break in the Exhibit Hall and Last Chance for Poster Viewing

1:55 Chairperson’s Remarks

John F. Kellie, Ph.D., Associate Fellow, GlaxoSmithKline

Process Control in an Era of Novel Biotherapeutics and New Technologies

Hao_ChenHao Chen, Ph.D., Director, Process Development & Engineering, Biologics & Vaccines, Merck & Co., Inc.

As the biologics market and pipeline grew significantly in recent years, the industry entered an era of novel modalities and new technologies, which brings both challenges and opportunities for process control: 1) medical breakthroughs with mAbs and novel modalities demand expedited development; 2) continuous manufacturing is gaining momentum for efficiency and low cost; 3) new technologies including single use technology and systems biology bring improved process efficiency and understanding.


2:45 NIR Evaluation and Applications in Upstream Process Development and Manufacturing

Brian_KentyBrian Kenty, Ph.D., Scientist, Manufacturing Sciences and Technology, MedImmune

Monitoring nutrient and metabolite concentrations in a cell culture process is an essential aspect of the upstream biopharmaceutical manufacturing process. In this work, near infrared spectroscopy was used to establish quantitative online readings for multiple cell culture constituents in a fed-batch bioreactor process. Multivariate models were developed using data generated at bench-scale and were integrated with an automated process control system in a GMP manufacturing facility.

3:15 MSApproaches for Monitoring Attributes: Connecting Forced Degradation Studies to Preclinical and Clinical Samples

John_KellieJohn F. Kellie, Ph.D., Associate Fellow, GlaxoSmithKline

CQAs are often identified through forced degradation studies and controlled through various manufacturing or formulation processes. Recent advances in MS technologies have enabled the quantification of CQAs from in-life study samples by MS-based assays. In-house approaches to achieve CQA monitoring from in-life samples will be discussed along with the advantages to such approaches, including identifying CQAs at an early stage and accelerated de-risking of CQAs.

3:45 Featured Poster Presentation: Evaluating the Downstream Process Modifications of a Commercial Monoclonal Antibody

Zhi LiZhi Li, Ph.D., Scientist, Bristol-Myers Squibb 

Recent upstream process improvements in mAb manufacturing have resulted in higher titers from the production bioreactor. A facility fit model was used to assess the downstream processing capability and identify process parameters that can be modified to accommodate the high titer. Lab-scale screening experiments were conducted to evaluate the impact of these modifications on performance and product attributes.

4:00 Refreshment Break

4:15 Connecting Process to Product Quality – A Case Study

Swapnil Bhargava, Ph.D., Director, Bioprocess Development, Seattle Genetics

Achieving and maintaining certain product quality attributes throughout the product lifecycle has been one of the main focus areas in recent years across the biotech industries. A thorough process-to-product quality understanding, which typically involved various aspects of process development groups, is essential to accomplish this goal. This study showcases an example of such collaboration among cell culture, analytical sciences and bioassay development groups to achieve targeted N-glycan profiles.

4:45 Data Management in Process Development as a Key to Process Understanding and Development Efficiency

Martin_MayerMartin Mayer, Director, evon GmbH, Austria

Bioprocess development and characterization rely on reasonable DoEs, meaningful on- and offline process monitoring concepts and methods for automated data handling, analysis and interpretation including data integrity issues. An obstacle preventing the implementation of these key issues into bioprocess operation is the lack of GAMP5 conform process control software tools designed for fully automated management of complex bioprocess data sets. This talk introduces a software and workflow approach to tackle these problems.

5:15 Close of Day

6:009:00 Recommended
Dinner Short Course*

SC7: Analytical Strategies for Comparability in Bioprocess Development

SC9: Transient Protein Production in Mammalian Cells

* Separate registration required

Friday, August 25

8:00 am Registration Open and Morning Coffee


8:25 Chairperson’s Remarks

Udayanath Aich, Ph.D., Principal Scientist, Sanofi Genzyme

8:30 Improving Commercial Manufacturing Process Development through Inline and Online Technologies

Mandy_LyMandy Ly, Associate Scientist, Cell Culture Process Development, Amgen

The development of commercial manufacturing processes is becoming increasingly complex as timelines shorten, therapeutic modalities diversify and cost reduction remains critical. To successfully meet these challenges, it is necessary to monitor and control critical process parameters in real-time or near real-time to meet necessary product quality attributes. Here we discuss various technologies and strategies to develop robust processes in this rapidly changing drug development landscape.

9:00 Case Study: Enhancing Upstream Process Control, from Cell Expansion to Harvest

Brandon_MooreBrandon Moore, Engineer II, Cell Culture Development, Biogen

This case study presents a PAT-centric approach to upstream process development which emphasizes the use of in situ biomass and other analytical probes for adaptive control during cell expansion and antibody production. This control method allows us to de-risk error-prone inoculation operations and reduce reliance on process assumptions and historical knowledge when projecting process performance. The resulting process features improved early deviation detection and run-to-run consistency with more robust product quality profiles.

9:30 Advances in Real Time and Near Real Time Measurement of Product and Process Related Attributes for Process Intermediates and End Product

Udayanath_AichUdayanath Aich, Ph.D., Principal Scientist, Biopharmaceutical Development, Sanofi-Genzyme

The PAT and QbD regulatory initiatives have provided a foundation for shifting the paradigm away from end-process release testing to real-time release testing. This presentation will focus on the recent advances in on-line and at-line measurements of product and process attributes and describe the BioPhorum Operations Group’s roadmap for ILM-RTR in industry practice and future vision for real-time release. We will also discuss case studies related to development and implementation of at-line measurement.

10:00 Networking Coffee Break


10:30 Specification Development throughout the Product Lifecycle

Paul_BigwarfePaul Bigwarfe, Ph.D., Director, Analytical Sciences, Industrial Operations and Product Supply, Regeneron Pharmaceuticals

Product specifications evolve with the development stage of the program, with the test panel and acceptance criteria likely changing over time. This talk will focus on strategies to set initial product specifications for preclinical and Phase I, and how they evolve up to and post commercialization. Examples will include how the test panel is driven by CQAs and your overall control strategy.

11:00 Setting Drug Substance CQA Acceptance Criteria and Incorporation into the Control Strategy and Specifications

Angela_LewandowskiAngela Lewandowski, Ph.D., Group Leader, Downstream Process Development, Bristol-Myers Squibb

This talk will focus on the strategy employed for setting drug substance CQA acceptance criteria for incorporation into the in-process control strategy, and linkage of such criteria to the specifications. Case studies for both mAbs and Fc-fusion proteins will be discussed.

11:30 A Playbook for Efficiently Creating and Maintaining a Holistic and Compliant Control Strategy for Legacy and New Products

Naveen_PathakNaveen Pathak, Head, QbD Systems, Shire Pharmaceuticals

Creating and maintaining a holistic and compliant control strategy requires an efficient QbD methodology spanning all three stages of lifecycle PV, significant investment in product and process characterization data which is aligned with the methodology, and an IT infrastructure for risk management as well as automated acquisition and data analysis post commercialization. A playbook of how these factors come together to create such a control strategy will be discussed.

12:00 pm Sponsored Presentation (Opportunity Available)  

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

1:15 Session Break


1:25 Chairperson’s Remarks

James Stonecypher, Ph.D., Senior Vice President, Head of Regulatory Affairs and Quality, Bonti

1:30 Current Trends in Biopharmaceuticals and Developing Fast Track Products

Frank_RiskeFrank J. Riske, Ph.D., Senior Consultant, BioProcess Technology Consultants, Inc.

The biopharmaceutical landscape has changed dramatically in recent years. While early biologics were made in bacteria or yeast, mammalian cells are now the predominant. There has also been an explosion of gene and cell therapies and new technologies such as Crispr Cas9. We’ll examine these trends and trends in developing molecules for orphan, fast-track, and breakthrough designations.

2:00 Communicating Your Manufacturing Process in Regulatory Submissions: Leveraging the “Information Delta (Δ)”

James_StonecypherJames Stonecypher, Ph.D., Senior Vice President, Head of Regulatory Affairs and Quality, Bonti

Significant thought and resources are put into process design, development, and control. The information that describes a manufacturing process in a regulatory submission often does not accurately reflect knowledge gains or current level of process-product understanding. This “information delta” contains valuable data that can be communicated in regulatory submissions to benefit developers. Opportunities for presenting manufacturing processes in regulatory submissions will be discussed.

2:30 Speaker has Cancelled Process Modeling, Monitoring and Understanding of UF/DF Operations

Natarajan Ramasubramanyan, Ph.D., Associate Director, Purification & Manufacturing Sciences, AbbVie

Ultrafiltration processes are part of every downstream process for biologics. It is one of the most important steps in a bioprocess as it ensures that the product is formulated into the right buffer conditions. In this talk, the implications of the importance of the formulation buffers will be discussed. In addition, a means of ensuring their composition and identity and monitoring the process to ensure consistency using Raman Spectroscopy will be provided. Process modeling approaches to understanding UF/DF processes will also be presented.

2:30 Leveraging Process Linkage and Challenge Studies to Define Control Strategies for Process Validation

Robert_Vonder_ReithRobert Vonder Reith, Senior Research Associate, Gilead Sciences

Identification and control of critical process parameters and their proposed operating ranges are required to demonstrate a suitable control strategy. To accelerate the classification of these parameters, challenge linkage studies, starting from cell culture throughout the downstream steps, were performed to assess the manufacturing process capabilities under “worst case” conditions for pre-determined CQAs. A control strategy and acceptable range was proposed based on the linkage study results and individual unit operation capabilities.

3:00 End of Process Characterization and Control meeting; Delegates may attend sessions of other programs.