p6

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 (Sapphire West Foyer)

MONDAY, JANUARY 14

7:00 am Registration and Morning Coffee (Sapphire West Foyer)

Knowledge Management in the Process Pipeline
Sapphire 411

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

Dhanasekharan_KumarKumar 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

von_Stosch_MoritzMoritz 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 (Sapphire & Aqua West Foyer)

 

High-Throughput Platforms: Data Management and Modeling
Sapphire 411

FEATURED PRESENTATION

10:45 NEW TIME: High-Throughput Pre-Formulation Platform: Large Dataset Generation and Evaluation in the Pre-NME Space Using a DoE Technique

LaBrenz_StevenSteven 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

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

Furtmann_NorbertNorbert 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.

11:45 NEW TIME: 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:

Carly Cox, Process Informatics Manager, Global Engineering, Pfizer

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

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

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

Additional Panelists To Be Announced

12:15 pm Sponsored Presentation (Opportunity Available)

12:45 Session Break

12:55 Luncheon Presentation II (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

Continued Process Verification
Sapphire 411

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

Orozco_RaquelRaquel Orozco, PhD, Principal 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

Cox_CarlyCarly 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 (Sapphire & Aqua Foyer)

Join your peers and colleagues for interactive roundtable discussions.

Click here for more details

 

Process Development and Validation
Sapphire 411

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

Johnson_KeithKeith 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

Schwartz_MatthewMatthew 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 NEW TIME: Automated Data Management and Assurance of Data Integrity during High-Throughput Characterization of Proteins

Siedler_MichaelMichael 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.

6:00 - 7:15 Welcome Reception in the Exhibit Hall with Poster Viewing (Sapphire Ballroom)

7:15 Close of Day

TUESDAY, JANUARY 15

8:00 am Registration and Morning Coffee (Sapphire West Foyer)

CHO Cell Line Development and Engineering
Sapphire 411

8:45 Chairperson’s Remarks

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

8:50 Real-Time Monitoring of Metabolism for Enhanced Understanding of Cell Behavior

Nicholas Trunfio, PhD, Senior Research Data Scientist, Sartorius Stedim North America, Inc.

Multivariate calibration models facilitate the real-time monitoring of cell culture nutrients and metabolic byproducts, but the intersection of cellular metabolism, spectroscopy and multivariate analysis creates unique challenges in model training. This work demonstrates that when the right preprocessing techniques are applied, models can be generated that apply across a wide range of culture conditions. The implications of the resulting real-time metabolic characterization are discussed within the context of clone selection.

9:20 Integration of Cell Culture High-Throughput Techniques and Multivariate Statistical Modeling to Simplify the Development of CHO Cell Lines

Mora_AlessandroAlessandro 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.

9:50 Coffee Break in the Exhibit Hall with Poster Viewing (Sapphire Ballroom)
Sapphire 400

11:00 Genetic Engineering Process Optimization in CHO Cells

Stephanie L. Sandefur, MSc, Consultant Biologist, Bioprocess Research & Development, Eli Lilly and Company

Over the past decade, considerable progress has been made in improving the effectiveness and efficiency of generating highly productive recombinant CHO cell lines. While these efforts have been primarily centered on driving cell culture productivity, more recently, focus has turned to approaches to impact product quality. This presentation describes potential approaches to maximizing the effectiveness of host cell engineering and reducing the time to successfully impact biotherapeutic product quality profiles.

11:30 De novo DNA Synthesis Using Enzymes

Sebastian Palluk, MSc, CTO, Ansa Biotechnologies

DNA synthesis, the ability to "write" DNA, is a foundational technology in life sciences research and engineering. Currently, all synthetic DNA is made using organic chemistry via a method that has remained unchanged for 35 years and has approached a plateau. This talk describes current efforts in the field of enzymatic DNA synthesis and presents a novel DNA synthesis technology that is based on polymerase-nucleotide conjugates.

12:00 pm Research Cell Bank Generation in under 14 Weeks by Integrating Single Cell Analysis into the SUREtechnology Platform

Girod_Pierre-AlainPierre-Alain Girod, PhD, CSO, Selexis SA

 

Currently, Selexis’ SUREtechnology Platform™ generates research cell banks in as little as 14 weeks, with optimal clone selection requiring 6-8 of those weeks. Single-cell analysis platforms, capable of parallel analyses, have the capacity to reduce those timelines, but must be optimized to each cell system.  Selexis has integrated the BEACON® optofluidic platform into the SUREtechnology Technology workflow plus developed a clone prediction tool that collectively shave weeks off the current development timelines. Case studies discussed.  


12:30 Session Break

Pall_Biotech 12:40 Luncheon Presentation: A SMART Platform for Scalable Biotherapeutic Development: DNA to 200L Single-use Stirred-tank Bioreactor – a Case Study and Workflow

Goel_DivyaDivya Goel, Celltheon


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