Informa
Key Sessions

Anurag Khetan

Advances In Cell Line Development And Process Development To Speed Mab And Non Mab Assets Faster To Clinic

Bristol-Myers Squibb

Susan Burke, Ph.D.

Digitization of Raw Material Data and The Application of Data Analytics to Better Understand and Control Variation

Amgen

8:00am - 8:50am

Coffee and Registration

More
Showing of Streams
10:30am - 11:00am

Networking Refreshment Break

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

Networking Luncheon

More
Showing of Streams
3:00pm - 3:30pm

Networking Refreshment Break

More
Showing of Streams
5:00pm - 5:05pm
End of Pre-Conference Symposia

End of Pre-Conference Symposia

More
8:00am - 8:50am 50 mins
Coffee and Registration
8:50am - 9:00am 10 mins
Pre-Conference Symposium: Cell Line Development & Engineering
Chairperson’s Opening Remarks
8:50am - 9:00am 10 mins
Pre-Conference Symposium: Raw Materials
Chairperson’s Opening Remarks
8:50am - 9:00am 10 mins
Pre-Conference Symposium: Drug Product/Formulations & Fill-Finish
Chairperson’s Opening Remarks
8:50am - 9:00am 10 mins
Pre-Conference Symposium: PAT and Advanced Process Control
Chairperson's opening Remarks
8:50am - 9:00am 10 mins
Pre-Conference Symposium: Next Generation Tools for Manufacturing Regenerative Medicine Products at Scale: In collaboration with ARMI
Chairperson’s Opening Remarks
8:50am - 9:00am 10 mins
Pre-Conference Symposium: Single-Use Technologies for Cell & Gene Therapies
Chairperson's Opening Remarks
  • Instructor James Dean Vogel - Founder and Director , The BioProcess Institute
8:50am - 10:20am 90 mins
Info
Pre-Conference Symposium: Data Science Tools for Accelerated Product Life Cycle
Data Science Tools for Accelerated Product Life Cycle
  • Christoph Herwig - Head Biochemical Engineering, Institute of Chemical Engineering, TU Wien, Austria
  • Thomas Zahel - Head of Innovation, Exputec

Course Objective

Hands-on learning of basic principles and best practices performing data analytics and data management for integrated bioprocesses. Designed for the biopharmaceutical and industrial biotech industry. The course topics include

  • best bioprocess data analytics principles
  • design of experiments
  • data management and contextualization of data sources of different origin
  • basic statistics for root cause analysis, scale-up, scale-down and comparability studies
  • Process validation analytics and monitoring (CPV)


Primary Audience

This course is designed for all individuals who are involved in bioprocess development & manufacturing as well as process validation. This includes bioprocess development scientists, engineers, manufacturing and quality supervisors, and management. No statistical or mathematical background is required. Interactive seminar Bring your own laptop. You will perform exercises on bioprocess data management and analytics using the web-based educational software tool inCyght®.


Course Outline

  • Digital Bioprocess Lab/ Plant: Data Management Workflows
  • Monitoring & Trending, raw data visualization ◦ Inspecting your data for outliers
  • Setting process phases
  • Networking break
  • Bioprocess data analytics: Best practices
  • Conversion of raw data to reliable feature based information
  • Design of Experiments (DoE) ◦ Integrated Process Analysis over multiple unit operations
  • Root Cause Analysis of process variability
  • Comparability studies: Scale-up & Scale-Down and process validation tasks
9:00am - 9:30am 30 mins
Pre-Conference Symposium: Cell Line Development & Engineering
Advances In Cell Line Development And Process Development To Speed Mab And Non Mab Assets Faster To Clinic
  • Anurag Khetan - Site Director, Biologics Process Development, Bristol-Myers Squibb
9:00am - 9:30am 30 mins
Info
Pre-Conference Symposium: Raw Materials
Overview of BioPhorum Raw Material Variability (RMV) Workstream
  • Chiali Liu, Ph.D. - Principal Scientist, Janssen Supply Chain

Presenting the vision, value, and achievements of BioPhorum Raw Material Variability (RMV) workstream. This workstream provides an effective forum for biopharmaceutical manufacturers and raw material suppliers to collaborate, to enable data and information sharing and benchmarking, and to explore practical solutions and mitigation strategies. Progress and results from subteams working on various topics will be highlighted.

9:00am - 9:30am 30 mins
Info
Pre-Conference Symposium: Drug Product/Formulations & Fill-Finish
Annex 1 Draft/Preventing Contamination and Cross Contamination during Aseptic Fill-Finish
  • Richard Denk - Head Containment, SKAN AG

During aseptic fill-finish the cleaning and decontamination should be validated to avoid microbiological contamination. Furthermore, every second new developed Biopharmaceutical Product is considered as highly potent or toxic. Those kinds of products require also cleaning and cross contamination requirements. What limits for cleaning should be considered for aseptic fill finish and the non-product contact surfaces close to open containers like Vials or Syringes.

9:00am - 9:30am 30 mins
Info
Pre-Conference Symposium: PAT and Advanced Process Control
Investigating USP & DSP Tools For Analysis: Round Table:
  • Ting-Kuo Huang, PhD - Senior Engineer, Genentech

Table 1: In The Bioreactor (30 minutes)

  • Latest sensor technologies - soft sensors?
  • Does the type of sensor used pose limitations?
  • Online biomass probe
  • On-line/At-line technologies
  • Non-invasive techniques
  • Take samples out of the bioreactor and look at them using mass spectrometry
  • Validating the analytical methods
  • Pilot plant
  • How is automation being implemented?
  • QbD strategy

Speaker: Ting-Kuo, Senior Engineer, Genentech

Table 2: For Protein Purification (30 minutes)

  • Implementing PAT for protein purification and cleaning up the protein
  • Real time on-line or at-line analytics for purification steps
  • How is automation being implemented?
  • QbD strategy
9:00am - 9:30am 30 mins
Pre-Conference Symposium: Next Generation Tools for Manufacturing Regenerative Medicine Products at Scale: In collaboration with ARMI
Development of Tissue Therapies as compared to the Development of Cell and Gene Therapies: A Look Back, A Look Ahead
  • Jennifer Briggs Braswell, PhD - Chief Administrative Officer, ARMI, BioFab, USA
9:00am - 10:30am 90 mins
Info
Pre-Conference Symposium: Single-Use Technologies for Cell & Gene Therapies
Single-Use Technologies for Cell & Gene Therapies
  • Instructor James Dean Vogel - Founder and Director , The BioProcess Institute

An Introduction to Single-Use Technologies and the specific attributes and quality needs when implementing Single-Use Technologies in Cell and Gene Therapy Manufacturing. 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 Cell and Gene Production Methods and Regulatory Considerations
  • Single-Use Bioprocess Equipment - Materials of Construction
  • Single-Use Advantages and Disadvantages
  • Single-Use Requirements for Cell and Gene Therapies 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!

9:30am - 10:00am 30 mins
Pre-Conference Symposium: Cell Line Development & Engineering
Streamlining Early Cell Line Development to Increase Speed and Efficiency
  • Dr Thomas Jostock, PhD - New Technologies Network Leader/Novartis Leading Scientist, Novartis
9:30am - 10:00am 30 mins
Info
Pre-Conference Symposium: Raw Materials
Digitization of Raw Material Data and The Application of Data Analytics to Better Understand and Control Variation
  • Susan Burke, Ph.D. - Staff Scientist, Material Science Leader, Bioprocess R&D, Amgen


This talk will review the challenges and opportunities associated with the digitization of Raw Material related data and how access to that data can then be used to understand and potentially control the impact of Raw Material variation on process and product variation during the manufacture of biopharmaceutical products.

9:30am - 10:00am 30 mins
Info
Pre-Conference Symposium: Drug Product/Formulations & Fill-Finish
Mitigating Particle Problems During Biopharmaceutical Formulation, Storage, and Use
  • Dr. James Colandene, Ph.D. - Manager, Biopharmaceutical Product Sciences, GSK

Particle formation remains a challenge in biopharmaceutical drug development and can occur during manufacturing, storage, or drug product administration. The causes vary and there are examples related to protein instability, surfactant degradation, and glass delamination. This presentation includes case studies in which challenges related to these issues occurred and strategies were implemented to mitigate them.

9:30am - 10:00am 30 mins
Info
Pre-Conference Symposium: PAT and Advanced Process Control
Using Raman Spectroscopy for Monitor and Control of Critical Quality Attributes in Ultrafiltration/Diafiltration of Biotherapeutics
  • Christina Passno - Process Development Engineer III, Regeneron Pharmaceuticals, Inc.

To support process intensification for the downstream production of biotherapeutics, process analytical technology (PAT) is essential for rapid process monitoring and process control. Raman Spectroscopy (Raman) can be implemented at key points in the purification process as a PAT strategy. Regeneron Pharmaceuticals has developed tools to incorporate Raman and predictive model generation for the control and automation of the ultrafiltration/diafiltration (UF/DF) unit operation. This study experimentally characterizes chemometric models developed from Raman spectra for real-time monitoring and control of critical quality attributes such as protein concentration and buffer excipient levels.

9:30am - 10:00am 30 mins
Pre-Conference Symposium: Next Generation Tools for Manufacturing Regenerative Medicine Products at Scale: In collaboration with ARMI
Raw Materials/Starting Materials
  • Derek Hei - Senior VP, Manufacturing, Quality & Regulatory, BlueRock Therapeutics, USA
10:00am - 10:30am 30 mins
Info
Pre-Conference Symposium: Cell Line Development & Engineering
Optimizing Cell Line Development with Beacon®: On-Chip Cloning Technology To Improve Performance And Reduce Timelines
  • Rachel Ferguson - Associate Scientist II, Cell Culture Development, Biogen

The cell line development process - specifically single cell cloning and clone assessment - requires lengthy, labor-intensive processes to identify a highly productive and stable lead clone. While the probability of identifying such clones increases as the number of clones screened increases, there is a limit on traditional cloning and screening capacity. Berkeley Lights, Inc. (BLI) has developed a novel microchip system capable of generating and screening thousands of individual clones while shortening development timelines. The Beacon® platform was directly compared to the Biogen platform development process, producing high-quality clonal cell lines with improved titers. A comprehensive data package will be presented to highlight the benefits and challenges of transitioning to microchip technology for optimized, expedited cell line development.

10:00am - 10:30am 30 mins
Info
Pre-Conference Symposium: Raw Materials
Understanding and Controlling the Impact of Elemental Impurities in Cell Culture
  • Thomas Matthews - Scientist II, Biogen

Unexpected variation of trace elements in cell culture raw materials has historically posed a problem for commercial biopharmaceutical operations. Variations lead to shifts in cellular metabolism, decreased cell growth, lowered productivity, unexpected shifts in product quality and the loss of whole batches. This presentation explores the mapping of elemental variability from key raw materials to their impact on the bioreactor, coupled with a detailed analytical characterization of common raw materials and their historical elemental impurity profiles. We show how elemental mapping and proper process design can minimize the impact of unavoidable raw material impurity variation.

10:00am - 10:30am 30 mins
Pre-Conference Symposium: PAT and Advanced Process Control
Accurate Biomass Soft-Sensor Using 2-D Fluorescence and MARS Modeling
  • Mark Durkop - Project Lead, University of Natural Resources and Life Sciences
10:00am - 10:30am 30 mins
Pre-Conference Symposium: Next Generation Tools for Manufacturing Regenerative Medicine Products at Scale: In collaboration with ARMI
Cell Culture and Expansion
  • Taby Ahsan - Director of Development, RoosterBio Inc., USA
  • Bruce A Bunnell - Professor, Director of the Tulane Center for Stem Cell Research & Regenerative Medicine, USA
10:30am - 11:00am 30 mins
Networking Refreshment Break
11:00am - 11:30am 30 mins
Info
Pre-Conference Symposium: Cell Line Development & Engineering
Anticipating Cell Lines Challenges for CMC Readiness
  • Alessandro Mora - Senior Scientist, CMC Operations, Jounce Therapeutics

In an organization focused on novel immuno-oncology targets, the development of CHO production cell lines must account for occasional off-platform approaches:  novel molecule formats, alternative antibody isotypes, product quality characteristics and their implication for the mechanism of action of a drug. Concurrently, the fundamental requirements of high titer, robust growth and stability determine the late stage manufacturing strategy. In this talk, relevant examples will be discussed.

11:00am - 11:30am 30 mins
Pre-Conference Symposium: Raw Materials
Media Raw Material Variability: Case Studies in Different Stages of Product Lifecycle
  • Divya Vasudevan - Engineer II, Pharma Innovation, Technology and MSAT, Genentech
11:00am - 11:30am 30 mins
Info
Pre-Conference Symposium: Drug Product/Formulations & Fill-Finish
Syringe Filling of a High-Concentration mAb Formulation: Issues and Mitigation Strategies
  • Kashappa-Goud Desai - Scientific Leader, Biopharmaceutical Product Sciences, GSK

Successful large-scale manufacturing by an automated syringe filling machine is a challenging task. Clogging of filling needles during syringe filling of high-concentration mAb formulations by an automated filling machine is a major hurdle for successful large-scale manufacturing. Preventing needle clogging is essential to ensure minimal fill weight variation, product waste and manufacturing down-time. Understanding the factors that influence the propensity for filling needle clogging is essential to develop mitigation strategies for large-scale manufacturing. This presentation summarizes the issues faced during syringe filling process and mitigation strategies. Learnings of this work can be leveraged for the development of syringe filling process for other high-concentration mAb products or to mitigate the needle clogging issue.

11:00am - 11:30am 30 mins
Pre-Conference Symposium: PAT and Advanced Process Control
Real-time titer measurement methods to control Protein A column loading during continuous antibody production - a technology overview
  • Jeff Goby - Scientist II, Boehringer Ingelheim
11:00am - 11:30am 30 mins
Pre-Conference Symposium: Next Generation Tools for Manufacturing Regenerative Medicine Products at Scale: In collaboration with ARMI
Cell Harvest
11:00am - 12:30pm 90 mins
Info
Pre-Conference Symposium: Single-Use Technologies for Cell & Gene Therapies
Single-Use Technologies for Cell & Gene Therapies
  • Instructor James Dean Vogel - Founder and Director , The BioProcess Institute

An Introduction to Single-Use Technologies and the specific attributes and quality needs when implementing Single-Use Technologies in Cell and Gene Therapy Manufacturing. 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 Cell and Gene Production Methods and Regulatory Considerations
  • Single-Use Bioprocess Equipment - Materials of Construction
  • Single-Use Advantages and Disadvantages
  • Single-Use Requirements for Cell and Gene Therapies 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!

11:00am - 12:30pm 90 mins
Info
Pre-Conference Symposium: Data Science Tools for Accelerated Product Life Cycle
Data Science Tools for Accelerated Product Life Cycle - Cont'd
  • Christoph Herwig - Head Biochemical Engineering, Institute of Chemical Engineering, TU Wien, Austria
  • Thomas Zahel - Head of Innovation, Exputec

Course Objective

Hands-on learning of basic principles and best practices performing data analytics and data management for integrated bioprocesses. Designed for the biopharmaceutical and industrial biotech industry. The course topics include

  • best bioprocess data analytics principles
  • design of experiments
  • data management and contextualization of data sources of different origin
  • basic statistics for root cause analysis, scale-up, scale-down and comparability studies
  • Process validation analytics and monitoring (CPV)


Primary Audience

This course is designed for all individuals who are involved in bioprocess development & manufacturing as well as process validation. This includes bioprocess development scientists, engineers, manufacturing and quality supervisors, and management. No statistical or mathematical background is required. Interactive seminar Bring your own laptop. You will perform exercises on bioprocess data management and analytics using the web-based educational software tool inCyght®.


Course Outline

  • Digital Bioprocess Lab/ Plant: Data Management Workflows
  • Monitoring & Trending, raw data visualization ◦ Inspecting your data for outliers
  • Setting process phases
  • Networking break
  • Bioprocess data analytics: Best practices
  • Conversion of raw data to reliable feature based information
  • Design of Experiments (DoE) ◦ Integrated Process Analysis over multiple unit operations
  • Root Cause Analysis of process variability
  • Comparability studies: Scale-up & Scale-Down and process validation tasks
11:30am - 12:00pm 30 mins
Info
Pre-Conference Symposium: Cell Line Development & Engineering
Challenges On Stable Cell Line Development Using Horizon CHO GS Knock Out System
  • Qinghua (Jenny) Zhao - Associate Director, Salubris Biotherapeutics

The stable cell line for antibody production was developed using Horizon CHO GS knockout system through optimization of transfection, and culture medium during cloning steps. The electroporation transfection procedure with Lonza system was developed based on different programs and buffers, cuvette size, host cell health, DNA quality and quantity. To increase transfection efficiency and protein expression, FACS method was also introduced to verify targeted product expression and quality during cloning selection.

11:30am - 12:00pm 30 mins
Info
Pre-Conference Symposium: Raw Materials
Advancement in Raw Material Management and Control

A Representative from Boehringer Ingelheim

11:30am - 12:00pm 30 mins
Info
Pre-Conference Symposium: Drug Product/Formulations & Fill-Finish
Feasibility of Frozen BDS Storage Of Ultra-High Concentration mAbs
  • Eric Falcone - Development Scientist I, Pharmaceutical Development, Alexion

One of the biggest challenges in formulation development of ultra-high concentration mAbs is the concentration dependent degradation route associated with aggregation. Conventional approach to extend shelf life for biotherapeutics in liquid formulations to mitigate degradation, such as aggregation, involves BDS storage at subzero temperatures. However, potential cryoconcentation may be a larger risk for ultra-high concentration mAbs. Careful design of small scale frozen storage feasibility studies and selection of current frozen storage technologies makes frozen BDS storage of ultra-high concentration mAbs possible.

11:30am - 12:00pm 30 mins
Pre-Conference Symposium: PAT and Advanced Process Control
Evaluation of PAT Co-Laboratory Process Development Model
  • Zachary Houle - Senior Development Specialist, Upstream Process Development, Takeda
11:30am - 12:00pm 30 mins
Pre-Conference Symposium: Next Generation Tools for Manufacturing Regenerative Medicine Products at Scale: In collaboration with ARMI
Scaffold Fabrication - 3D Printing
12:00pm - 12:30pm 30 mins
Info
Pre-Conference Symposium: Cell Line Development & Engineering
Consistently Delivering Outperforming Cell Lines Leveraging Extensive CLD Expertise and Innovative Seeding Platform
  • Camille Evenou - Scientist, Celonic AG

Breakthrough biologics of tomorrow seldom reach their potential due to inefficiencies in the development of high performing cell lines. Industry leading biosolutions provider Celonic and cutting edge platform developer Solentim joined hands to collaborate on development of a robust workflow with an objective of consistently delivering outperforming cell lines. The scope of this collaboration was to design and assess the most optimal seeding and growth conditions to ensure a robust clone selection workflow and generating rich, high quality supporting data for regulatory submissions.

12:00pm - 12:30pm 30 mins
Pre-Conference Symposium: Raw Materials
Spotlight Presentation
12:00pm - 12:30pm 30 mins
Info
Pre-Conference Symposium: Drug Product/Formulations & Fill-Finish
The Effect of Surfactant Excipients on the Stabilization of Proteins during Mechanical, Oxidative and Thermal Stress
  • Dr. Frank Romanski, Ph.D - Head of Global Marketing, BASF

Non-ionic surfactants are often used to stabilize biologics, and while the underlying mechanisms of degradation have been considerably reviewed, the influences of individual surfactants, both positive and negative remain an unmet challenge. In this work, a multitude of surfactant excipients including common polysorbates with innovative excipients like polyoxyl 15 hydroxystearate are evaluated for model protein stability under mechanical, thermal and oxidative stress.

12:00pm - 12:30pm 30 mins
Pre-Conference Symposium: PAT and Advanced Process Control
Spotlight Presentation
12:00pm - 12:30pm 30 mins
Pre-Conference Symposium: Next Generation Tools for Manufacturing Regenerative Medicine Products at Scale: In collaboration with ARMI
Scaffold Fabrication
12:30pm - 1:30pm 60 mins
Networking Luncheon
1:30pm - 2:00pm 30 mins
Info
Pre-Conference Symposium: Cell Line Development & Engineering
Accelerating Timelines through Implementation of TLA Sequencing in Cell Line Selection
  • Marieke Koedood Zhao - Director, Cell Line Development, Mersana Therapeutics

Cell line stability studies is a rate limiting step in the selection of recombinant protein production cell lines. This case study demonstrates the utility of TLA sequencing prior to cell line stability studies to accelerate production timelines. Early identification of lead cell lines enables cell culture process development in parallel with confirmatory cell line stability studies. The benefits and limitations of TLA data in driving cell line selection is presented, as well as its potential to facilitate workflows that further reduce cell line development timelines.

1:30pm - 2:00pm 30 mins
Info
Pre-Conference Symposium: Raw Materials
Raw Material Control Strategies: From User Requirements to Design of Specifications
  • Tatsiana Mironava - Senior Specialist Technical Specifications, Amgen

Raw materials may be effectively managed through end-to-end control strategies that focus on thoughtful determination of User Requirements, defining associated raw material attributes and implementing appropriate control strategies through a combination of meaningful supplier engagement and manufacturer’s internal testing. This presentation will describe such an approach and associated efforts to manage raw materials for biologics manufacturing at Amgen.

1:30pm - 2:00pm 30 mins
Info
Pre-Conference Symposium: Drug Product/Formulations & Fill-Finish
Challenges and Strategies for Low-Dose Drug Product Development During In-Use Administration Studies
  • Apurva More - Scientist, Global Pharmaceutical Development Biologics, Sanofi

Establishing stability, safety and efficacy of a biological drug product during in-use administration studies is crucial for clinical and commercial success of drug product. Regulatory guidelines require manufactures to demonstrate compatibility of biologics with diluents and dosage delivery devices. It is highly critical and challenging to evaluate if the complete dose is administered to the patient especially when the target dose is extremely low (concentrations ranging from ng/mL to ug/mL). Additionally, dose escalation studies during first-in-human studies further demand the dose to be further reduced. In these scenarios, the in-use developmental activities pose analytical challenges for low dose drug product characterization. This presentation will focus on case studies to discuss in-use developmental challenges especially for low dose drug products and strategies for their successful clinical administration

1:30pm - 2:00pm 30 mins
Info
Pre-Conference Symposium: PAT and Advanced Process Control
Enhancing Process Optimization Using Advanced Analytical and Data Handling
  • Melvin Koch - Principal Scientist, CPAC, University of Washington

There is Industrial interest in the use of new technology for optimizing process operations - which includes continuous processing. Regulatory initiatives such as PAT and Quality by Design (QbD) have encouraged approaches to process intensification and process optimization. These have allowed for better process understanding, which leads to developing the operational design space for the process. Process control systems can then be improved using sensor inputs.

1:30pm - 3:00pm 90 mins
Info
Pre-Conference Symposium: Single-Use Technologies for Cell & Gene Therapies
Single-Use Technologies for Cell & Gene Therapies
  • Instructor James Dean Vogel - Founder and Director , The BioProcess Institute

An Introduction to Single-Use Technologies and the specific attributes and quality needs when implementing Single-Use Technologies in Cell and Gene Therapy Manufacturing. 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 Cell and Gene Production Methods and Regulatory Considerations
  • Single-Use Bioprocess Equipment - Materials of Construction
  • Single-Use Advantages and Disadvantages
  • Single-Use Requirements for Cell and Gene Therapies 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!

1:30pm - 3:00pm 90 mins
Info
Pre-Conference Symposium: Data Science Tools for Accelerated Product Life Cycle
Data Science Tools for Accelerated Product Life Cycle - Cont'd
  • Christoph Herwig - Head Biochemical Engineering, Institute of Chemical Engineering, TU Wien, Austria
  • Thomas Zahel - Head of Innovation, Exputec

Course Objective

Hands-on learning of basic principles and best practices performing data analytics and data management for integrated bioprocesses. Designed for the biopharmaceutical and industrial biotech industry. The course topics include

  • best bioprocess data analytics principles
  • design of experiments
  • data management and contextualization of data sources of different origin
  • basic statistics for root cause analysis, scale-up, scale-down and comparability studies
  • Process validation analytics and monitoring (CPV)


Primary Audience

This course is designed for all individuals who are involved in bioprocess development & manufacturing as well as process validation. This includes bioprocess development scientists, engineers, manufacturing and quality supervisors, and management. No statistical or mathematical background is required. Interactive seminar Bring your own laptop. You will perform exercises on bioprocess data management and analytics using the web-based educational software tool inCyght®.


Course Outline

  • Digital Bioprocess Lab/ Plant: Data Management Workflows
  • Monitoring & Trending, raw data visualization ◦ Inspecting your data for outliers
  • Setting process phases
  • Networking break
  • Bioprocess data analytics: Best practices
  • Conversion of raw data to reliable feature based information
  • Design of Experiments (DoE) ◦ Integrated Process Analysis over multiple unit operations
  • Root Cause Analysis of process variability
  • Comparability studies: Scale-up & Scale-Down and process validation tasks
2:00pm - 2:30pm 30 mins
Info
Pre-Conference Symposium: Cell Line Development & Engineering
Further Streamlining CLD: Combining Single Cell Cloning and Enrichment using FACS into Semi-Solid Media
  • Eric Lee - Associate Scientist II, Cell Culture Development, Biogen

The development and selection of high titer recombinant cell lines can be a long and arduous process.  To better meet rising patient demand amidst the competitive biologics landscape, we seek to improve out methodologies to identify more highly productive cell lines while reducing timelines. Our legacy workflow utilizes independent enrichment and monoclonality steps based on imaging technologies that leverage fluorescence to identify robust cell lines and ensure regulatory compliance.  We have recently developed a method that overlays these two functional steps.  With modifications to the cell culture matrix, we have enabled Fluorescence Activated Cell Sorting (FACS) directly into a microscopy based monoclonality identification step that is coupled to additional enrichment, all without major reductions in cell line outgrowth. FACS gating for rare events has enabled identification of more highly productive clones while reducing the overall screening burden. This new method additionally reduces our cell line development timeline by three weeks, while enhancing the ability to generate high titer clones.

2:00pm - 2:30pm 30 mins
Pre-Conference Symposium: Raw Materials
Development of A Holistic Approach to Raw Material Risk Assessments Through Industry Collaboration
  • Kara Quinn - Global Technical Operations Raw Material Center of Excellence, Merck & Co., Inc
2:00pm - 2:30pm 30 mins
Info
Pre-Conference Symposium: Drug Product/Formulations & Fill-Finish
In Pursuit of Robust Drug Product Manufacturing Process for mAbs
  • Omkar Dhamale, Ph.D. - Research Investigator, Drug Product Technologies, Incyte

Drug product manufacturing is a critical segment in a biopharmaceutical product’s roadmap starting from cell line development leading up to commercial launch and beyond. This presentation will review and evaluate fill-finish manufacturing processes, discuss a few operational challenges and assess their impact on drug product quality. The application of single use disposable commodities in mAb based drug product manufacturing will be highlighted.

2:00pm - 2:30pm 30 mins
Info
Pre-Conference Symposium: PAT and Advanced Process Control
PAT in Freeze drying - Measurement of Residual Moisture Content by Non-Invasive Methods
  • Timothy McCoy - Head Formulation & Process Development, Sanofi
  • Measurement of residual moisture is a subject of focus in the area lyophilization - how representative and also how fast we can get data.
  • Presentation will discuss monitoring of FD in development, scale up in general and focus on various methods to measure moisture
  • Lastly, the noninvasive methods of residual moisture measurement will be presented,- pros and cons of each method, verifying these approached for development and scale up use and lastly, application not only to scale up batches but possible real time PAT applications to support commercial production.
2:30pm - 3:00pm 30 mins
Info
Pre-Conference Symposium: Cell Line Development & Engineering
Spotlight Presentation
2:30pm - 3:00pm 30 mins
Pre-Conference Symposium: Raw Materials
Spotlight Presentation
2:30pm - 3:00pm 30 mins
Info
Pre-Conference Symposium: Drug Product/Formulations & Fill-Finish
Spotlight Presentation
2:30pm - 3:00pm 30 mins
Pre-Conference Symposium: PAT and Advanced Process Control
Spotlight Presentation
3:00pm - 3:30pm 30 mins
Networking Refreshment Break
3:30pm - 4:00pm 30 mins
Info
Pre-Conference Symposium: Cell Line Development & Engineering
Engineering CHO Cells: How to Herd Cats
  • David James - Professor of Bioprocess Engineering and Director of the Advanced Biomanufacturing Centre, University of Sheffield

Engineering complex process performance characteristics such as cell growth and productivity is an unpredictable challenge made more difficult by the inherent variability of CHO cells, protein products and production processes. There is no one-size-fits-all solution. However, most companies engineer cells to produce a specific recombinant product using a generic vector, host cell line and medium. Constraints are built in from the start, and this can be a particular problem for difficult-to-express proteins. As a new paradigm for cell line development we are developing a hyper-variable design space for mammalian cell factory engineering that utilises directed and synthetic variation of chemical, genetic and cellular input components as a core strategy to optimize cell functional performance beyond natural limits.

3:30pm - 4:00pm 30 mins
Info
Pre-Conference Symposium: Raw Materials
Developing an Accurate and Efficient Technical Raw Material Risk Assessment Process
  • Sheryl Kane - Principal Engineer, Amgen

In order to continually improve the reliability of Amgen’s manufacturing operations, we have recently developed a new raw material risk assessment process. The process is flexible to accommodate a wide range of materials (from chemicals to single-use systems) and modalities (from small molecules to cell therapies). Guiding principles include building and maintaining a library of raw material risks and mitigations to promote efficiency and consistency; assessing groups of similar materials rather than every material individually; and triaging out low-risk materials quickly to focus on potentially higher risks. The new process ensures that all new materials are evaluated for technical risks prior to introduction in the manufacturing network, and emphasizes communication of existing risks and mitigations across different products and manufacturing sites. Outcomes include a single, searchable source of truth for raw material risks and mitigations, and a ~60% reduction in time required to perform a new risk assessment for a product.

3:30pm - 4:30pm 60 mins
Pre-Conference Symposium: Drug Product/Formulations & Fill-Finish
Panel Discussion: Latest Strategies to Overcome Challenges in Drug Product, Fill Finish & Formulation
3:30pm - 4:00pm 30 mins
Info
Pre-Conference Symposium: PAT and Advanced Process Control
Translating Data Into Decisions: Multivariate Data Analysis
  • Ting-Kuo Huang, PhD - Senior Engineer, Genentech
  • Predict product quality from sensors
  • What parameters are associated with good quality?
  • How to pool data, revise it, reduce it and make a decision out of it?
  • Utilising MVDA in PAT
  • Algorithms to extract desirable information
  • Applying it to downstream
  • Define guided sampling
  • Define end-point determination strategies
3:30pm - 5:00pm 90 mins
Info
Pre-Conference Symposium: Single-Use Technologies for Cell & Gene Therapies
Single-Use Technologies for Cell & Gene Therapies
  • Instructor James Dean Vogel - Founder and Director , The BioProcess Institute

An Introduction to Single-Use Technologies and the specific attributes and quality needs when implementing Single-Use Technologies in Cell and Gene Therapy Manufacturing. 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 Cell and Gene Production Methods and Regulatory Considerations
  • Single-Use Bioprocess Equipment - Materials of Construction
  • Single-Use Advantages and Disadvantages
  • Single-Use Requirements for Cell and Gene Therapies 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!

3:30pm - 5:00pm 90 mins
Info
Pre-Conference Symposium: Data Science Tools for Accelerated Product Life Cycle
Data Science Tools for Accelerated Product Life Cycle - Cont'd
  • Christoph Herwig - Head Biochemical Engineering, Institute of Chemical Engineering, TU Wien, Austria
  • Thomas Zahel - Head of Innovation, Exputec

Course Objective

Hands-on learning of basic principles and best practices performing data analytics and data management for integrated bioprocesses. Designed for the biopharmaceutical and industrial biotech industry. The course topics include

  • best bioprocess data analytics principles
  • design of experiments
  • data management and contextualization of data sources of different origin
  • basic statistics for root cause analysis, scale-up, scale-down and comparability studies
  • Process validation analytics and monitoring (CPV)


Primary Audience

This course is designed for all individuals who are involved in bioprocess development & manufacturing as well as process validation. This includes bioprocess development scientists, engineers, manufacturing and quality supervisors, and management. No statistical or mathematical background is required. Interactive seminar Bring your own laptop. You will perform exercises on bioprocess data management and analytics using the web-based educational software tool inCyght®.


Course Outline

  • Digital Bioprocess Lab/ Plant: Data Management Workflows
  • Monitoring & Trending, raw data visualization ◦ Inspecting your data for outliers
  • Setting process phases
  • Networking break
  • Bioprocess data analytics: Best practices
  • Conversion of raw data to reliable feature based information
  • Design of Experiments (DoE) ◦ Integrated Process Analysis over multiple unit operations
  • Root Cause Analysis of process variability
  • Comparability studies: Scale-up & Scale-Down and process validation tasks
4:00pm - 5:00pm 60 mins
Info
Pre-Conference Symposium: Cell Line Development & Engineering
Panel Discussion: Integrating New Engineering and Cell Line Development Technologies into Established Workflows
  • Michael Brem - Senior Scientist, Cell Line Development, Cytovance Biologics Inc.
  • What new technologies have been adopted by industry and used routinely in cell line development?
  • Success rates and realities of engineering tools? e.g. genomics, genome editing, CRISPR, NGS, targeted integration
  • What is the industry status on CRISPR adoption?
  • Are titres and timelines better with new technologies compared to standard approaches?
  • What are the best, efficient and smart ways to use cell line engineering in a workflow?
  • Where and how are industry incorporating new technologies and engineering for clinical and pipeline products when timelines are critical?
  • Feasibility of cell line engineering: Are people doing customised cell line engineering for individual projects and is this feasible?
  • Industry opinions on engineering: Engineer the host or look for replacements?
4:00pm - 4:30pm 30 mins
Info
Pre-Conference Symposium: Raw Materials
Qualification of Raw Material for Clinical Trials
  • Jeanet S.K. Kring - Senior Development Scientist, CMC API GMP Material Responsible, Novo Nordisk A/S, Denmark

My presentation will include examples of how to qualify raw materials for use in clinical trials Phase 1, 2 and 3 using a risk-based approach.

Further my presentation will include examples of which documentation could be established during qualification. Examples of challenges and mitigations during qualification will also be addressed.

4:00pm - 4:30pm 30 mins
Info
Pre-Conference Symposium: PAT and Advanced Process Control
Smart Data Analytics for Biomanufacturing Process Modeling and Advanced Process Control
  • Richard Braatz, PhD - Edwin R. Gilliland Professor, Faculty Research Officer, Massachusetts Institute of Technology
  • How can chemometric and other data-driven models be used to control the process?
  • How can we apply machine learning and other data analytics tools effectively?
  • How to balance the use of first-principles, data-driven, and hybrid models?
  • What data analytics tool should be used for a particular dataset and user objective? What variables should be included in the model?
  • How to quantify the predictive value of a model when some data could be biased?
4:30pm - 5:00pm 30 mins
Info
Pre-Conference Symposium: Raw Materials
From Sequence to Product in Hours - Cell Free Expression for Next-Generation Therapeutics
  • Philip Probert, PhD - Senior Upstream Scientist, CPI Biologics

Technical advances are making personalised healthcare a reality. This poses a challenge to conventional production approaches, but for which cell-free expression (CFE) could be the solution. CFE has historically been utilised for production of small quantities of product, due to its rapid setup, short duration and flexibility. Its application to clinical manufacture is restricted by its high cost and low yields. The raw materials, particularly the cell lysate, are responsible for significant variability in performance and their lack of a consistent source continues to prevent effective yield improvement. Overcoming this variability would permit rapid optimisation of cell-free yields and support routine robust reaction performance and its implementation for manufacture of therapeutics. This talk will explore methods for reproducible production of the raw materials required for CFE and their application to high-throughput optimisation of yield, using our own work as a case study. Through applying cGMP manufacture principles to lysate production, we were able to develop a scalable and robust E. coli lysate generation process, identify quality control parameters and thereby resolve issues with batch-batch variability between lysates. This consistent lysate was subsequently used to support the development of a high-throughput platform for optimisation of CFE at microscale, through use of an automated liquid handling system in tandem with design of experiment statistical design. With the standardisation of raw material components, our work demonstrates how efficiently cell-free reactions can be optimised to drive up yields. This, in combination with the linear nature of cell-free scale up, should enable CFE to meet the demands of small batch manufacture and therefore should be considered when assessing methods of production for the next generation of therapeutics.

5:00pm - 5:05pm 5 mins
End of Pre-Conference Symposia

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