BioProcess International is part of the Informa Connect Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 3099067.

Informa
Key Sessions

Christian Airiau, Ph.D

Integration of Empirical, PAT and Mechanistic Modeling to Support Biologics Process Development Activities

Sanofi

Richard Braatz, PhD

Process Control, Automation, and Real-Time Release Testing for Continuous Processing

Massachusetts Institute of Technology

7:15am - 8:10am

Technology Workshop with Light Continental Breakfast

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

Refreshment Break in the Poster & Exhibit Hall

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

Networking Luncheon in the Poster & Exhibit Hall

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

Closing Remarks and Look Ahead to BPI 2020

More
7:15am - 8:10am 55 mins
Technology Workshop with Light Continental Breakfast
8:10am - 8:15am 5 mins
Cell Culture & Upstream Processing
Chairperson's Opening Remarks
8:10am - 8:15am 5 mins
Speed from Gene to Market
Chairperson’s Opening Remarks
8:10am - 8:15am 5 mins
Recovery & Purification
Chairperson’s Opening Remarks
8:10am - 8:15am 5 mins
Intensified and Continuous Processing
Chairperson’s Opening Remarks
8:10am - 8:15am 5 mins
Bioprocessing 4.0
Chairperson's Opening Remarks
8:10am - 8:15am 5 mins
Analytical & Quality
Chairperson's Opening Remarks
8:10am - 9:40am 90 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 - Head, Process Sciences, Novartis
8:15am - 8:45am 30 mins
Intensified and Continuous Processing
Overcoming Issues of Control – 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
Info
Analytical & Quality
Biophorum Development Group – Registered Content For S.4.2 Analytical Procedures
  • Michael Clark - PhD., Associate Director, Biologics CMC Sciences, Abbvie

A standard component of biopharmaceutical marketing applications is the S.4.2 Analytical Procedures section, which defines the analytical methods used for the release specifications and stability testing of drug substance and drug product.  Although this section is addressed in multiple regulatory guidances, the content requirements are not clearly defined and are largely left to the discretion of individual companies when submitting regulatory filings.
The BioPhorum Development Group (BPDG) is an industry-wide consortium enabling networking and sharing of best practices for the development of biopharmaceuticals.  The BPDG CMC Regulatory subteam conducted a survey among 23 collaborating companies to assess the content and level of details that are provided in the S.4.2 Analytical Procedures section.  The resulting survey output provides a guideline to ensure that all appropriate information is provided, while also strategically allowing for potential method optimization and document lifecycle management.  In addition, the survey identifies regulatory agencies that are known to have more comprehensive information requirements.

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
Speed from Gene to Market
Challenges in Cell Line and Manufacturer Changes During the Conduct of Phase I/II Clinical Investigation
  • Ru Zang - Associate Director, Mersana
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 - Global DSP Skill Center Head, Sanofi
8:45am - 9:15am 30 mins
Intensified and Continuous Processing
Demonstration of Robust Viral Clearance Across Two-Column Continuous Protein A Chromatography
  • James Angelo, Ph.D. - Scientist, 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
Info
Cell Culture & Upstream Processing
Scientific Track Presentations
9:15am - 9:45am 30 mins
Info
Recovery & Purification
MabXpure for innovative Host Cell Proteins clearance strategies and flowthrough platform enabling technology.
  • Dr. Fabien Rousset, PhD - Head of Bioseparations, Daicel Bioseparations / Chiral Technologies Inc

MabXpure is an innovative technology for HCP/DNA and product related impurities depletion strategies. Single-use technology, working under flowthrough conditions, can be used under bulk version during clarification operations as filter aid or under prefilled format as filter resin cartridge for polishing steps, by removing co-eluted species. From lab to large scale, case studies will be presented (Sanofi and Polyplus Transfection).

9:15am - 9:45am 30 mins
Intensified and Continuous Processing
Scientific Track Presentations
9:15am - 9:45am 30 mins
Info
Bioprocessing 4.0
Beyond Bioprocessing 4.0: The Convergence of IT, OT and Processing Technologies Today and Tomorrow
  • Vikas Revankar - Head of digital Product Management - BioContinuum™ Platform, Merck

The transformative impact that digital technologies have had on other industries’ manufacturing operations through IT and OT can be applied to the evolution happening in biopharma today. Examples of commonly used unit operations such as bioreactor, mixing and chromatography will be presented to illustrate incremental improvements that can be achieved today, and what the future looks like with the convergence of Operational Technology (OT), Information Technology (IT) and existing processing technologies.


9:15am - 9:45am 30 mins
Analytical & Quality
Scientific Track Presentations
9:45am - 10:30am 45 mins
Refreshment Break in the Poster & Exhibit Hall
10:30am - 11:00am 30 mins
Cell Culture & Upstream Processing
Innovative Process Development Strategies for New More Complex Products – Bi/Multi Specific
10:30am - 11:00am 30 mins
Speed from Gene to Market
Control Strategy Development for Accelerated Programs
  • Daniel Sayut - Senior Scientist, AbbVie
10:30am - 11:00am 30 mins
Recovery & Purification
Holistically Integrate Process Analytics Data with Allotrope Data Framework for Real Time Process Monitoring and Release Testing
  • Gang Xue - Scientific Director, Process Analytics, Amgen
10:30am - 11:00am 30 mins
Intensified and Continuous Processing
Integration of Empirical, PAT and Mechanistic Modeling to Support Biologics Process Development Activities
  • Christian Airiau, Ph.D - Global Head, Data Sciences - Biologics Development, Sanofi
10:30am - 11:00am 30 mins
Bioprocessing 4.0
Integration of Empirical, PAT and Mechanistic Modeling to Support Biologics Process Development Activities
  • Christian Airiau, Ph.D - Global Head, Data Sciences - Biologics Development, Sanofi
10:30am - 11:00am 30 mins
Info
Analytical & Quality
A Fast Formulation Development Platform for Multi-specific Antibodies
  • Maggie Zhu - Senior Associate Scientist, Systimmune Inc

A fast formulation development platform for multi-specific antibodies will be presented. This platform starts with an initial two days of efforts on optimal formulation pH identification through aggregation investigation by SEC and DLS, followed with approximate two rounds of two-week screening studies to identify the appropriate stabilizers and concentrations of selected components. At the end, a formulation for preclinical studies will be finalized in a three-month confirmation stability study.

10:30am - 11:35am 65 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
Speed from Gene to Market
Effective Process Design, Development and Scale-Up for Speed to Market
  • Sourav Kundu, PhD - Senior Director, Teva Pharmaceuticals
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
Intensified and Continuous Processing
Latest Developments in Attribute Monitoring for Next-Generation Continuous Biomanufacturing
  • Alicia Zeng, Ph.D. - Process Development Scientist, Amgen
11:00am - 11:30am 30 mins
Bioprocessing 4.0
Latest Developments in Attribute Monitoring for Next-Generation Continuous Biomanufacturing
  • Alicia Zeng, Ph.D. - Process Development Scientist, 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, Ph.D., - 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
Tech Workshop 1
FUJIFILM Diosynth Technology Workshop
11:35am - 12:05pm 30 mins
Info
Tech Workshop 2
Genscript Technology Workshop
11:35am - 12:05pm 30 mins
Info
Tech Workshop 3
Intertek Technology Workshop
11:35am - 12:05pm 30 mins
Info
Tech Workshop 4
Lonza Technology Workshop
11:35am - 12:05pm 30 mins
Info
Tech Workshop 5
Thermo Technology Workshop
11:35am - 12:05pm 30 mins
Info
Tech Workshop 6
Thermo Technology Workshop
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
Intensified and Continuous Processing
Using Soft Sensors for Adaptive Feeding Strategies
  • Kenneth Lee, PhD - Senior Scientist, AstraZeneca
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
Info
Speed from Gene to Market
The Cost of Speed – How Preclinical Shortcuts Impact Molecule Value and Tech Transfer
  • Regina Au - Principal, BioMarketing Insight
  • The Target Product Profile (TPP) is the most important aspect of R&D in creating value for the molecule and in turn value for Tech Transfer.  R&D, Marketing and Clinical will define the optimal TPP (differentiation, clinical impact, value proposition) that meets the needs of the customers or stakeholders in achieving product adoption leading to market access where the product will be available to the patient.  This will also drive the design protocol.
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
Intensified and 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
Info
Analytical & Quality
Hybrid Modeling and Intensified DOE Enabling Faster Process Understanding and Model Predictive Control
  • Mark Dürkop - Project Lead, University of Natural Resources and Life Sciences

Process development and characterization is a very time and resource intense work. Often only the endpoints of the processes are described, neglecting process dynamics. As an alternative approach intensified Design of Experiments together with hybrid models are presented to not only overcome the endpoint evaluation problem of bioprocesses, but to present a solution for a robust design space description.

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 II, 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
Intensified and 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