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7:15am - 8:00am

Technology Workshop with Light Continental Breakfast

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Showing of Streams
9:45am - 10:30am

Refreshment Break in the Poster & Exhibit Hall

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Showing of Streams
12:05pm - 1:30pm

Networking Luncheon in the Poster & Exhibit Hall

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Showing of Streams
5:00pm - 5:10pm

Closing Remarks and Look Ahead to BPI 2020

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7:15am - 8:00am 45 mins
Technology Workshop with Light Continental Breakfast
8:00am - 8:15am 15 mins
Cell Culture & Upstream Processing
Chairperson's Opening Remarks
8:00am - 8:15am 15 mins
Speed from Gene to Market
Chairperson’s Opening Remarks
8:00am - 8:15am 15 mins
Recovery & Purification
Chairperson’s Opening Remarks
8:00am - 8:15am 15 mins
Continuous Processing
Chairperson’s Opening Remarks
8:00am - 8:15am 15 mins
Bioprocessing 4.0
Chairperson's Opening Remarks
8:00am - 8:15am 15 mins
Analytical & Quality
Chairperson's Opening Remarks
8:00am - 9:45am 105 mins
Info
Hands On Training Course
Single-Use Technologies for Biotherapeutics
  • Instructor James Dean Vogel - Founder and Director , The BioProcess Institute

Overview:

An Introduction to Single-Use Technologies and the specific attributes and quality needs when implementing Single-Use Technologies in Biomanufacturing. BPI’s training workshop will focus on the importance and the implementation of Single-Use technologies in production of manufacturing facilities. The format of the course includes valuable and unbiased classroom instruction by industry expert James Dean Vogel, P.E. With Mr. Vogel’s assistance, course participants will experience the latest Single-Use products first hand during the lab portion of the course.

Topics include:

  • Brief Review of Bioprocess Production Methods and Regulatory Considerations
  • Single-Use Bioprocess Equipment - Materials of Construction
  • Single-Use Advantages and Disadvantages
  • Single-Use Requirements and Risks
  • Single-Use Components available for Hands-On Demonstration

Attendees range from end-users, suppliers, sales and regulatory personnel who have a general understanding of the SUT industry and want to experience Single-Use products hands on!


*Separate Registration Required to Attend this Training Course

8:15am - 8:45am 30 mins
Info
Cell Culture & Upstream Processing
Systems Biology Approach for CHO Cell Culture Process Development
  • Andrew Yongky - Scientist II,Upstream Process Development, Global Product Development and Supply, Bristol-Myers Squibb

Rapid decline in cell viability and lower mAb production were observed in BMSCHO1, a proprietary cell line, cell culture containing lower concentrations of several medium components. RNA-Seq and NMR/LCMS were employed to collect transcriptomics and metabolomics data. Systems biology analysis revealed pathways that were differentially impacted by those medium components. The knowledge gained presented opportunities for cell culture improvement through metabolic or cell line engineering strategies.

8:15am - 8:45am 30 mins
Recovery & Purification
KEYNOTE ADDRESS - Utilizing Knowledge to Drive Downstream Process Development
  • Lars Pampel, Ph.D - Team Head, Process Development, Novartis Pharma AG
8:15am - 8:45am 30 mins
Continuous Processing
Overcoming Issues of Control in Continuous Processing – What are the Tools Needed for Controlling a Continuous Process
  • Christoph Herwig - Head Biochemical Engineering, Institute of Chemical Engineering, TU Wien, Austria
8:15am - 8:45am 30 mins
Bioprocessing 4.0
Application of AI and Machine Learning in Manufacturing and Predictive Maintenance
  • Syama Adhibhatta - Head of Data Systems and Analytics, Bristol-Myers Squibb
8:15am - 8:45am 30 mins
Analytical & Quality
Registered Content for S.4.2 Analytical Procedures: BioPhorum Development Group Observations Based on a Survey of Member Companies
  • Michael Clark - PhD., Associate Director, Biologics CMC Sciences, Abbvie
8:45am - 9:15am 30 mins
Info
Cell Culture & Upstream Processing
Optimizing CO2 Concentration To Improve Cell Culture Performance At The Manufacturing Scale By Different Gassing Strategies: From Manual Manipulation To Predictive Control
  • Linda Hoshan - Senior Scientist, Merck

High CO2 concentrations in mammalian cell culture significantly impact the cell culture performance (e.g., protein productivity), and often become a challenge during process scale up and technology transfer for manufacturing. This presentation will highlight our gassing strategies to improve cell culture performance by minimizing CO2 accumulation. Successful implementation of these gassing strategies has led to robust cell culture processes and seamless technology transfers to multiple manufacturing facilities.

8:45am - 9:15am 30 mins
Info
Speed from Gene to Market
Case Studies from Accelerated, Parallel Tech Transfers of a Recombinant Protein Vaccine to Internal and External Manufacturing Sites

A Representative from Merck

8:45am - 9:15am 30 mins
Recovery & Purification
EASY Process: A Game Changer to Purify mAbs - A Continuous, Single-Path Stream Flowing Through, Simple, Ready to Use, Disposable Media, Without Protein A, Without Columns and Using Only One Buffer
  • Benoit Mothes, PharmD - Head of Global Skill Center DSP Breakthrough Technologies, Sanofi
8:45am - 9:15am 30 mins
Continuous Processing
Demonstration of Robust Viral Clearance Across Two-Column Continuous Protein A Chromatography
  • Nripen Singh, Ph.D. - Associate Director, MS&T Downstream, Bristol-Myers Squibb
8:45am - 9:15am 30 mins
Info
Bioprocessing 4.0
A Streamlined Machine Learning Approach in Assistance of Manufacturing Process Investigation and Performance Evaluation
  • Jun Ren - Data Scientist / Manufacturing Scientist, Biogen

In this talk, we will discuss a novel approach to determine batch performance similarity based on K Nearest Neighbors (KNN). This tool was designed to support troubleshooting activities (quality deviations) and to assess process performance. In addition, we will present our strategy to integrate the required data sources and data systems (analytics and dashboarding) in order to streamline and automate this capability.

8:45am - 9:15am 30 mins
Info
Analytical & Quality
Instigating A Life Cycle Analytical Procedure
  • Steven Walfish - Principal Scientist & Standards Liaison, USP

The analytical lifecycle consists of three stages: (1) design and development, (2) performance qualification, and (3) continued performance verification. It is strongly related to the Quality by Design concept given in the ICH-Q8 guidance. This contrasts with ICH-Q2 recommendations that only focus on the validation step to evaluate the performance of an analytical procedure.  This presentation covers the statistical methods necessary to set a target profile incorporating the measurement uncertainty to establish decision rules.  Based on the method development and risk profile, a statistically valid replication strategy is developed to ensure high confidence in assay results.

9:15am - 9:45am 30 mins
Cell Culture & Upstream Processing
Concurrent Scientific & Technology Presentations
9:15am - 9:45am 30 mins
Speed from Gene to Market
Concurrent Scientific & Technology Presentations
9:15am - 9:45am 30 mins
Recovery & Purification
Concurrent Scientific & Technology Presentations
9:15am - 9:45am 30 mins
Continuous Processing
Concurrent Scientific & Technology Presentations
9:15am - 9:45am 30 mins
Bioprocessing 4.0
Concurrent Scientific & Technology Presentations
9:15am - 9:45am 30 mins
Analytical & Quality
Concurrent Scientific & Technology Presentations
9:45am - 10:30am 45 mins
Refreshment Break in the Poster & Exhibit Hall
10:30am - 11:00am 30 mins
Cell Culture & Upstream Processing
Novel Bispecific Heterodimeric IgG Antibody: Upstream Process Development to Increase Product Purity and Titer
  • Ning Liu, Ph.D. - Sr Consultant Engineer, Eli Lilly and Company
10:30am - 11:00am 30 mins
Speed from Gene to Market
Speed to BLA for Accelerated Programs
  • Nicholas Abu-Asi, Ph.D. - Principal Scientist, AbbVie
10:30am - 11:00am 30 mins
Recovery & Purification
Data Engineering, Capture, and Integration
  • Gang Xue - Scientific Director, Process Analytics, Amgen
10:30am - 11:00am 30 mins
Continuous Processing
Integration of Online Real Time Process Monitoring Data to Enable Automated Feedback Control
  • Christian Airiau, Ph.D - Global Head, Data Sciences - Biologics Development, Sanofi
10:30am - 11:00am 30 mins
Bioprocessing 4.0
Integration of Online Real Time Process Monitoring Data to Enable Automated Feedback Control
  • Christian Airiau, Ph.D - Global Head, Data Sciences - Biologics Development, Sanofi
10:30am - 11:00am 30 mins
Info
Analytical & Quality
Predicting & Controlling Protein Aggregation & Stability For Formulation & Delivery
  • Maggie Zhu - Senior Associate Scientist, Systimmune Inc
  • Developing predictive models for looking at aggregation and concentrated protein solutions to understanding phase separation
  • Predicting how long will aggregation be prevented?
  • Stability predictions based on structure and high throughput methods that allow for small amounts of protein to screen for stability
  • Balancing product quality and viscosity
10:30am - 12:05pm 95 mins
Info
Hands On Training Course
Single-Use Technologies for Biotherapeutics
  • Instructor James Dean Vogel - Founder and Director , The BioProcess Institute

Overview:

An Introduction to Single-Use Technologies and the specific attributes and quality needs when implementing Single-Use Technologies in Biomanufacturing. BPI’s training workshop will focus on the importance and the implementation of Single-Use technologies in production of manufacturing facilities. The format of the course includes valuable and unbiased classroom instruction by industry expert James Dean Vogel, P.E. With Mr. Vogel’s assistance, course participants will experience the latest Single-Use products first hand during the lab portion of the course.

Topics include:

  • Brief Review of Bioprocess Production Methods and Regulatory Considerations
  • Single-Use Bioprocess Equipment - Materials of Construction
  • Single-Use Advantages and Disadvantages
  • Single-Use Requirements and Risks
  • Single-Use Components available for Hands-On Demonstration

Attendees range from end-users, suppliers, sales and regulatory personnel who have a general understanding of the SUT industry and want to experience Single-Use products hands on!


*Separate Registration Required to Attend this Training Course

11:00am - 11:30am 30 mins
Info
Cell Culture & Upstream Processing
Optimisation Of Scalable Transfection Conditions For AAV Production
  • Helen Young - Upstream Scientist, CPI, National Biologics Manufacturing Centre

The continual expansion of the gene therapy market is reliant on large quantities of virus so the scalability of transfection processes is key. AAV (recombinant adeno-associated virus) is a common gene delivery system and it is often produced in adherent cells. Small scale production in static flasks is impractical for larger titre requirements. Developing a cost effective, high yield process that works for multiple serotypes would be an effective way of meeting industry demand. We aimed to develop an optimised process at small scale that could be transferred to an adherent reactor for larger scale production. Triple PEI-mediated transient transfection of HEK293T cells was carried out in chemically defined media on adherent surfaces. Small scale DOE (design of experiment) screens were performed at 96 and 12 well scales before being verified in T flasks. Factors such as media type, media volume and PEI:DNA ratios were all explored before a process was finalised. The process was then ran in the iCELLis nano reactor to ensure it was scalable and reproducible. Viral titre and full vs empty capsid ratios were calculated using commercial ELISA and qPCR kits. Initial screens focused on optimising conditions to improve yield, with the largest increase being a result of changing the transfection media. Other factors such as reducing plasmid quantity gave comparable results to the original process though were further investigated due to them lowering production costs. Moving between 2D flask and 3D reactor systems posed challenges as some factors were difficult to scale. Through small scale process optimisation we have succeeded in developing a base platform for scalable AAV production that in future could be used for mass virus production.

11:00am - 11:30am 30 mins
Info
Speed from Gene to Market
Single Cycle Process Development

A Representative from Pfizer

11:00am - 11:30am 30 mins
Recovery & Purification
Using Real Time Manufacturing Data for Real Time Process Monitoring and Control
  • Syama Adhibhatta - Head of Data Systems and Analytics, Bristol-Myers Squibb
11:00am - 11:30am 30 mins
Continuous Processing
Advanced in Attribute Measurement for Next-Generation Continuous Biomanufacturing
  • Gang Xue - Scientific Director, Process Analytics, Amgen
11:00am - 11:30am 30 mins
Bioprocessing 4.0
Advanced in Attribute Measurement for Next-Generation Continuous Biomanufacturing
  • Gang Xue - Scientific Director, Process Analytics, Amgen
11:00am - 11:30am 30 mins
Info
Analytical & Quality
NMR as a Quantitative Universal Proton Detector in Biopharmaceutical Manufacturing and R&D: Applications to Process Component and Trace Impurity Analysis in Complex Matrices
  • Gennady Khirich - Associate Scientist, Genentech

Total process control and impeccable quality are two hallmark goals that the biopharmaceutical industry actively strives to achieve. This critically rests upon the foundation of robust and diverse analytics programs, spanning myriad technologies and methods for case-specific analyses of process components and trace impurities. Complicating matters are the facts that analytical matrices are typically complex, often requiring additional chemical treatment during sample preparation and often resulting in loss of sensitivity and accuracy during detection and quantitation, respectively. NMR, which may be regarded as a quantitative universal proton detector, is a mature technology with a very rich history, making it ideally suited to alleviate many of these challenges, and thus making it a particularly convenient and efficient technology to apply to a wide variety of problems common to R&D and manufacturing in the biopharmaceutical industry. These include - but certainly are not limited to - the verification of the concentrations of stock solutions; buffer component stability; quantitation of solution components in cell culture; out of spec investigations; process component clearance, excipient quantitation, and trace impurity analysis directly in protein pools. In this talk, multiple case studies will be presented that highlight the successful application of quantitative NMR (qNMR) as a single flexible technology across various areas of biopharmaceutical development and manufacturing.

11:35am - 12:05pm 30 mins
Cell Culture & Upstream Processing
Concurrent Technology Workshops
11:35am - 12:05pm 30 mins
Speed from Gene to Market
Concurrent Technology Workshops
11:35am - 12:05pm 30 mins
Recovery & Purification
Concurrent Technology Workshops
11:35am - 12:05pm 30 mins
Continuous Processing
Concurrent Technology Workshops
11:35am - 12:05pm 30 mins
Bioprocessing 4.0
Concurrent Technology Workshops
11:35am - 12:05pm 30 mins
Analytical & Quality
Concurrent Technology Workshops
12:05pm - 1:30pm 85 mins
Networking Luncheon in the Poster & Exhibit Hall
1:30pm - 2:00pm 30 mins
Info
Cell Culture & Upstream Processing
Dynamical Mathematical Model of CHO Cell Culture
  • Veronique Chotteau, PhD - Researcher at KTH - Director of AdBIOPRO, AdBIOPRO - Competence Centre for Advanced Bioproduction by Continuous Process

We have created new approaches to develop dynamical mathematical models of bioprocesses based on the measurement of the extracellular components. To illustrate this, the central metabolism of CHO cell culture is modeled based on more than 100 biochemical reactions, with the reaction kinetics determined by a multi-linear Gaussian approach. In another example, the IgG glycosylation changes in response of varying the fed sugars is accurately modeled.  

1:30pm - 2:00pm 30 mins
Speed from Gene to Market
Balance of Risk in Speed to BLA
  • Molly McGlauglhin - Senior Vice President and Global Lead, Biologics CDMO, BioLexis
1:30pm - 2:00pm 30 mins
Recovery & Purification
Control of Protein Glycosylation in a Continuous Bioreactor Process
  • Rustin Shenkman, Ph.D. - Senior Development Engineer, BDS Process Development, Shire
1:30pm - 2:00pm 30 mins
Continuous Processing
Using Soft Sensors for Adaptive Feeding Strategies
  • Kenneth Lee, PhD - Scientist II, MedImmune
1:30pm - 2:00pm 30 mins
Info
Bioprocessing 4.0
Development and Implementation of PAT System for Advanced Biopharmaceutical GMP Manufacturing Continuous Improvement
  • Ting-Kuo Huang, PhD - Senior Engineer, Genentech

From efficient manufacturing strategy perspective, manufacturing continuous improvement is a key enabler for modernization of biopharmaceutical manufacturing to ensure long term reliable supply of good quality of product to patients. FDA and EMA consider PAT (Process Analytical Technology) to be a system for designing, analyzing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process materials and processes, with the goal of ensuring final product quality. The goal of PAT is to ensure real time monitoring, understanding and controlling the manufacturing process, which is consistent with the current drug quality philosophy: quality should be built-in or should be by design (i.e., building quality into products).

In this presentation, the strategy (stage-wise approach) and considerations (i.e., system design, change management, data integrity, automation integration, qualification and validation, and regulatory compliance, etc.) for the development and implementation of PAT system capability in a multiple-product (Clinical and Commercial products) GMP facility for biopharmaceutical manufacturing process will be discussed.  The outcome and progress presented are intended to share the PAT system development and implementation roadmap and experiences, which will be beneficial for all partners across the manufacturing network for developing innovative and efficient pharmaceutical development, manufacturing, and quality assurance.


1:30pm - 2:00pm 30 mins
Info
Analytical & Quality
Use of a QbD Analytical Target Profiles (ATPs) and DoE-Based Workflows in the Development of High Quality Analytical Methods
  • Qian Guan, PhD - Method Development Scientist II, Bristol-Myers Squibb

Development of robust analytical methods for product release and stability is essential to ensure optimal product development, patient safety, and commercial success. Applying a risk based harmonized method development approach, as driven by ICH Q14 framework and an announced revision of Q2(R1), is the main focus of this presentation. Analytical Target Profile (ATP)-driven, QbD method development workflow strategy was developed at BMS for establishment of robust separation methods for biologics. This presentation will detail the workflow for one of these methods and provide case studies.

1:30pm - 5:00pm 210 mins
Info
Hands On Training Course
Single-Use Technologies for Biotherapeutics
  • Instructor James Dean Vogel - Founder and Director , The BioProcess Institute

Overview:

An Introduction to Single-Use Technologies and the specific attributes and quality needs when implementing Single-Use Technologies in Biomanufacturing. BPI’s training workshop will focus on the importance and the implementation of Single-Use technologies in production of manufacturing facilities. The format of the course includes valuable and unbiased classroom instruction by industry expert James Dean Vogel, P.E. With Mr. Vogel’s assistance, course participants will experience the latest Single-Use products first hand during the lab portion of the course.

Topics include:

  • Brief Review of Bioprocess Production Methods and Regulatory Considerations
  • Single-Use Bioprocess Equipment - Materials of Construction
  • Single-Use Advantages and Disadvantages
  • Single-Use Requirements and Risks
  • Single-Use Components available for Hands-On Demonstration

Attendees range from end-users, suppliers, sales and regulatory personnel who have a general understanding of the SUT industry and want to experience Single-Use products hands on!


*Separate Registration Required to Attend this Training Course

2:00pm - 2:30pm 30 mins
Info
Cell Culture & Upstream Processing
From Big Data to Precise Understanding – The Quest for Meaningful Information
  • Anne Richelle - Senior Specialist - Metabolic Modeling, GSK

The emergence of high-throughput technologies created a paradigm shift in biotechnology, pushing the bottleneck to the interpretation of large data-sets and the generation of meaningful outcomes impacting process and product attributes. How can we create iterative sample-to-sample learning methods that provide increased understanding of the cellular physiology and process?

2:00pm - 2:30pm 30 mins
Speed from Gene to Market
The Cost of Speed – How Preclinical Shortcuts Impact Molecule Value and Tech Transfer
  • Regina Au - Principal, BioMarketing Insight
2:00pm - 2:30pm 30 mins
Recovery & Purification
Development and Characterization of Protein A and Cation Exchange Chromatography Steps for the Removal of High Levels mAb Fragment Impurities
  • Nathaniel Macapagal - Scientist I, Purification Process Sciences, MedImmune
2:00pm - 2:30pm 30 mins
Continuous Processing
Process Control, Automation, and Real-Time Release Testing for Continuous Processing
  • Richard Braatz, PhD - Edwin R. Gilliland Professor, Faculty Research Officer, Massachusetts Institute of Technology
2:00pm - 2:30pm 30 mins
Info
Bioprocessing 4.0
From Big Data to Precise Understanding – The Quest for Meaningful Information
  • Anne Richelle - Senior Specialist - Metabolic Modeling, GSK

The emergence of high-throughput technologies created a paradigm shift in biotechnology, pushing the bottleneck to the interpretation of large data-sets and the generation of meaningful outcomes impacting process and product attributes. How can we create iterative sample-to-sample learning methods that provide increased understanding of the cellular physiology and process?

2:00pm - 2:30pm 30 mins
Analytical & Quality
Process Control, Automation, and Real-Time Release Testing for Continuous Processing
  • Richard Braatz, PhD - Edwin R. Gilliland Professor, Faculty Research Officer, Massachusetts Institute of Technology
2:30pm - 3:00pm 30 mins
Info
Cell Culture & Upstream Processing
Thinking Small: Scaling Down CHO N-1 Perfusion and Fed Batch Production Processes to ambr™250
  • Paul Rousseau - Engineer I, Biogen

Bench-scale perfusion and fed batch experimentation in non-disposable vessels require significant hands-on effort to execute and can be prone to failure from errors made during reactor set-up. Automated systems using single-use vessels, such as the ambr™250, could improve throughput and success rate. However, for companies with existing platforms that effectively scale from the bench to large-scale manufacturing, scale-down comparability becomes critical as the ambr™250 needs to match performance in order to replace bench experiments in clinical program development. This presentation shares an evaluation of the ambr250 where existing clinical N-1 perfusion and fed batch production processes were successfully scaled-down to match the bench-scale performance.

2:30pm - 3:00pm 30 mins
Speed from Gene to Market
PANEL DISCUSSION – The Downside to Speed to IND – Risks and Impact on Later Development
  • Moderator: Susan Dana Jones, Ph.D. - SVP, Product Development, Harpoon Therapeutics Inc.
2:30pm - 3:00pm 30 mins
Recovery & Purification
Creating an Approved Design Space for Therapeutic Protein Production
  • Alan Klotz, Ph.D. - Research Fellow, Pharmaceutical and Vaccine Science & Technology, Elanco Animal Health
2:30pm - 3:00pm 30 mins
Continuous Processing
Opportunities in Continuous Manufacturing: What Can We Learn from Other Industries to Guide a Successful Data Analytics and Process Control Paradigm
  • Lisa Graham, Ph.D. - Vice President, Analytics Engineering, Seeq
2:30pm - 3:00pm 30 mins
Info
Bioprocessing 4.0
Biopharmaceutical Process Models in the Digital Age - How To Make Value Out Of Data
  • Michael Sokolov - Postdoctoral Fellow and Lecturer, ETH Zurich and COO and Co-founder, DataHow AG

Continuous and robotic high throughput biomanufacturing, continuous data acquisition and standardization as well as the utilization of data- and knowledge-driven tools for process analysis and control thrive towards the standards of industry 4.0. Based on industrial case studies this presentation will highlight the enabling role of advanced process modeling for bioprocess digitalization and automation. Thereby, the importance of several model-assisted steps in data organization, alignment, pretreatment and eventually analytics will be discussed to transfer data through information to valuable knowledge and smart decision support.

2:30pm - 3:00pm 30 mins
Analytical & Quality
Opportunities in Continuous Manufacturing: What Can We Learn from Other Industries to Guide a Successful Data Analytics and Process Control Paradigm
  • Lisa Graham, Ph.D. - Vice President, Analytics Engineering, Seeq
5:00pm - 5:10pm 10 mins
Closing Remarks and Look Ahead to BPI 2020