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Cambridge Healthtech Institute’s 3rd Annual

Bioprocess Data Management

Advancing Bioprocessing through Instrumentation, Characterization, Control, and Analytics

January 14-15, 2019

 

The biopharmaceutical industry is meeting increasing demands and costs for biotherapeutics through process optimization. Advanced instrumentation through sampling techniques, new sensor technologies, and analyzers have emerged to monitor both upstream and downstream processes. When well-prepared and analyzed, this data leads to process knowledge, process control, and continuous improvement resulting in greater speed, quality, and economy.  

Cambridge Healthtech Institute’s 3rd Annual Bioprocess Data Management conference addresses statistical analysis strategies including multivariate data analysis (MVDA), quality by design (QbD), process analytical technology (PAT), and multi-attribute method (MAM), allowing for optimized and informed control of bioprocessing.

Final Agenda

SUNDAY, JANUARY 13

4:00 - 6:00 pm Pre-Conference Registration

MONDAY, JANUARY 14

7:00 am Registration and Morning Coffee

Knowledge Management in the Process Pipeline

9:00 Welcome by Conference Organizer

Mary Ann Brown, Executive Director, Conferences, Cambridge Healthtech Institute

9:05 Chairperson’s Opening Remarks

Steven LaBrenz, PhD, Scientific Director, Cell and Developability Sciences, Janssen R&D, BioTherapeutic Development

FEATURED PRESENTATION

9:10 A Control Strategy Approach to Knowledge Management – Some Perspectives

Kumar Dhanasekharan, PhD, Senior Director and Head, Biologics Process and Analytical Development, Amicus Therapeutics

This talk discusses key elements of a process control strategy (PCS) using Quality by Design (QbD) principles by leveraging technical development history, manufacturing history and process characterization to ultimately become a knowledge management tool in the product and process lifecycle of a molecule.

FEATURED PRESENTATION

9:50 Beyond Purely Data-Driven Approaches for Efficient Knowledge Management in Process Development

Moritz von Stosch, PhD, Senior Manager, Technical R&D, GlaxoSmithKline Vaccines

Knowledge from first principles is freely available and generally valid, and when integrated along with Artificial Intelligence (data-driven) methods, it can greatly improve the understanding and applicability. The applications of such an approach, referred to as hybrid modeling, to a fermentation and controlled drug release case are presented and the learnings from the development of these models are shared.

10:20 Networking Coffee Break

High-Throughput Platforms: Data Management and Modeling

10:45 Automated Data Management and Assurance of Data Integrity during High-Throughput Characterization of Proteins

Michael Siedler, PhD, Head, NBE High-Throughput and Advanced Formulation Sciences, Development Sciences, AbbVie Deutschland GmbH & Co. KG

Lab automation and high-throughput analytics provide huge amounts of data. Standard tools for managing the data and assuring data integrity are insufficient and could become a major hurdle for efficiently converting data into knowledge. Big data tools allow for new solutions for efficient automated data management as demonstrated by a use case.

11:15 Platformization of Multi-Specific Protein Engineering: From Handling Complex Data to Bioinformatics Workflow Support for High-Throughput Screening

Norbert Furtmann, PhD, Lab Head, Bioinformatics, High Throughput Biologics, Sanofi-Aventis Deutschland GmbH

As the success rate to identify a multi-specific lead molecule with favorable drug-like properties increases with the number of variants tested, we established a novel, automated platform process for the fast generation of large panels of multi-specific variants (up to 10,000). Here we report on our integrated bioinformatics platform to support and steer our screening process as well as on our tools for analyzing and handling the generated datasets.

FEATURED PRESENTATION

11:45 High-Throughput Pre-Formulation Platform: Large Dataset Generation and Evaluation in the Pre-NME Space Using a DoE Technique

Steven LaBrenz, PhD, Scientific Director, Cell and Developability Sciences, Janssen R&D, BioTherapeutic Development

To accelerate development timelines and improve early development outcomes, we have developed a high-throughput screening platform that adapts to the needs of a molecule, not adaptation of a molecule to a set-piece process. The process utilizes Design of Experiment structure and adapts inputs to generate an HTS experiment, tailored to the molecule. Using 384-well plate-based experimentation, DoE datasets are collected and analyzed to generate statistically significant results.

12:15 pm Sponsored Presentation (Opportunity Available)

12:45 Session Break

12:55 Luncheon Presentation to be Announced

1:25 Luncheon Presentation II (Sponsorship Opportunity Available)

Continued Process Verification

2:00 Chairperson’s Remarks

Moritz von Stosch, PhD, Senior Manager, Technical R&D, GlaxoSmithKline Vaccines

2:05 Strategy and Gap Analysis on Integrated Downstream Platform at Boehringer Ingelheim Fremont

Raquel Orozco, PhD, Senior Bioprocess Engineer, Bioprocess Engineering, Process Science, Boehringer Ingelheim Fremont, Inc.

BI Fremont, Inc. and Pfizer are investing in intensified (continuous/integrated) processing to provide early stage clinical material radically cheaper and with little development, while keeping in mind a path to commercialization. Our process is highly automated, reduces in-process pools, is fully disposable, and is GMP-capable. The downstream system is designed to be scalable-in-place by changing column sizes, and buffer volumes – enabling the ability to make up to 3kg of drug substance per day utilizing the same operational space. We have demonstrated the capability of making >1kg mAb of drug substance in ≤15 days using 100 L bioreactor and devised a strategy for a commercially available process. In order to implement the highly productive and automated process on site, stakeholders need a business case. This talk describes a thorough gap analysis on challenges around continuous viral inactivation, periodic viral filtration, periodic UFDF, buffer supply, and bioburden control.

2:35 Data at Your Fingertips: The Benefits of an Integrated Informatics System

Carly Cox, Process Informatics Manager, Global Engineering, Pfizer

With the advent of Continued Process Verification (CPV) and the data volumes and analysis frequencies, informatics systems that can help pull together data from disparate systems and organize it to be ready for analysis are more important than ever before. This talk covers some of the key elements to include in the design of an informatics system as well as the benefits that can be achieved.

3:05 Find Your Table and Meet Your BuzZ Session Moderator

3:15 BuzZ Sessions with Refreshments

Join your peers and colleagues for interactive roundtable discussions.

 

Process Development and Validation

4:30 Strategic Integration of the Multi-Attribute Method to Inform Bioprocess Optimization

Keith A. Johnson, PhD, Senior Principal Scientist, Analytical Research and Development, Pfizer

The development of a stable, high-yielding, and scalable bioprocess requires accurate and timely analytical monitoring of product quality attributes to better understand and control parameters that affect the product profile. The Multi-Attribute Method is intended to replace various analytical methods by utilizing liquid chromatography-mass spectrometry peptide mapping methodology to identify and monitor multiple product quality attributes simultaneously in a single assay to support process optimization.

5:00 Implementation of an Integrated Bioprocess Development Workflow Platform

Matthew Schwartz, MSc, Senior Scientist, Upstream Process Development, Celgene

Celgene’s strategy for implementation of a workflow platform for streamlining development activities will be presented. The new system acts as a cross-functional data backbone that integrates all bioprocess development workflows from post-discovery through transfer to manufacturing and will lead to a significant increase in Celgene’s operational efficiency and throughput. It has the capability to capture output data automatically (online, at-line and offline) along the process from various laboratory equipment.

5:30 PANEL DISCUSSION: Measuring, Storing, Modeling, and Analyzing Data: How Can We Extract Understanding and What Is the Value?

  • Can we link the information of various data sources via modeling techniques, achieving a more holistic view, and exploit redundancies for information consolidation?
  • Can we exploit the data for cross-process unit modeling, extracting traces of information from the process unit chain that otherwise would not be apparent?
  • From CQAs to CPPs and back: A need for one-stop historic-data-based solutions
  • Models as a tool for knowledge transfer management, or why data does not scale
  • Where do we get all the modeling and data scientists from?

Moderator:

Moritz von Stosch, PhD, Senior Manager, Technical R&D, GlaxoSmithKline Vaccines

Panelists to be Announced

6:00 - 7:15 Welcome Reception in the Exhibit Hall with Poster Viewing

7:15 Close of Day

TUESDAY, JANUARY 15

8:00 am Registration and Morning Coffee

CHO Cell Line Development and Engineering

8:30 Chairperson’s Remarks

Alessandro Mora, PhD, Senior Scientist, CMC, Jounce Therapeutics

8:35 Integration of Process Analytical Technology in Upstream Bioprocessing of CHO Cells

Erica Fratz-Berilla, PhD, Staff Fellow, Office of Biotechnology Products, Division of Biotechnology Review and Research II, U.S. Food and Drug Administration

Monitoring and control of upstream bioprocesses are vital to obtain high protein yields and meet all quality specifications for a biotherapeutic. Process analytical technology (PAT) can be used in process development to optimize physical, chemical, and biological parameters that may result in changes in CHO cell growth, titer, and product quality attributes. Additionally, PAT can be used to detect deviations in CHO cell culture parameters that may have otherwise remained unnoticed.

9:05 Integration of Cell Culture High-Throughput Techniques and Multivariate Statistical Modeling to Simplify the Development of CHO Cell Lines

Alessandro Mora, PhD, Senior Scientist, CMC, Jounce Therapeutics

The establishment of a robust high-throughput screening platform directly impacts the selection of CHO production clones. Consistent data collection, dataset construction and statistical modeling further improve the identification of bottlenecks during the clones’ transition into mature stages of upstream development. In this talk, we present the integration between 24-Deep Well Pates screening with Multivariate Data Analysis, and how their alignment simplifies upstream workflow, while elucidating CHO cells’ biology under process conditions.

9:35 Sponsored Presentation (Opportunity Available)

9:50 Coffee Break in the Exhibit Hall with Poster Viewing

11:00 Genetic Engineering Process Optimization in CHO Cells

Stephanie L. Sandefur, MS, Consultant Biologist, Bioproduct Research & Development, Eli Lilly and Company

11:30 A Multi-Landing Pad DNA Integration Platform for Mammalian Cell Engineering

Liliana Wroblewska, PhD, Principal Scientist, Biomedicine Design, Pfizer

Reliable, large-scale engineering of CHO cells through precise insertion of large amounts of heterologous DNA into well-characterized genomic loci would have broad applications for mammalian synthetic biology, recombinant protein production, and biomanufacturing. Using multi-gene payload vectors, cell lines with multiple landing pads, and recombinase technology, we demonstrated controlled integration of up to nine copies of a monoclonal antibody (about 100 kb of heterologous DNA), and a corresponding linear increase in antibody expression.

12:00 pm Talk Title to be Announced

Pierre-Alain Girod, PhD, CSO, Selexis SA

12:30 Session Break

12:40 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:10 Close of Bioprocess Data Management Conference


5:45 - 8:45 Recommended Dinner Short Courses*

SC3: Protein Aggregation: Mechanism, Characterization and Consequences

Click here for more details.

*Separate registration required

* The program is subject to change without notice, due to unforeseen reason.

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