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Key Sessions

Jens Vogel, Ph.D.

KEYNOTE ADDRESS: Fully Integrated Continuous Manufacturing v2.0 – Leveraging Lessons Learned and Technologies to Meet Evolving Biopharma Needs

Boehringer Ingelheim Fremont Inc

Mar 11
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8:00am - 8:50am

Registration and Morning Coffee

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Showing of Streams
8:00am - 8:50am 50 mins
Registration and Morning Coffee
8:50am - 9:00am 10 mins
Pre-Conference Symposia - Microbial Production
Chairperson’s Opening Remarks
8:50am - 9:00am 10 mins
Pre-Conference Symposia - Continuous and Intensified Bioprocessing
Chairperson’s Opening Remarks
8:50am - 9:00am 10 mins
Pre-Conference Symposia - PAT and Advanced Process Control
Chairperson’s Opening Remarks
8:50am - 9:00am 10 mins
Pre-Conference Symposia - Cell & Gene Therapy Bioprocessing
Chairperson’s Opening Remarks
9:00am - 10:30am 90 mins
Info
Pre-Conference Symposia - Microbial Production
Microbial Manufacturing

This multi speaker symposium will focus on the latest developments and application of microbial based production (yeast and E. coli).  

Some of the topics to be addressed through case study examples include:  

  • New Technologies for Primary Recovery and Cell Harvesting  

  • Downstream Processing in Microbial Production  

  • Automation, Robotics and High Throughput Process Development 

9:00am - 9:30am 30 mins
Info
Pre-Conference Symposia - Continuous and Intensified Bioprocessing
Accelerating Development through Innovation: Advances & Challenges in Vaccine Development
  • Tony D'Amore, PhD, MBA - Vice President, Product Research and Development, Sanofi Pasteur

This presentation will review the constraints and complexities of vaccine product development and manufacture.  With this increasing complexity, higher costs and competition, evolutions in bioprocess and analytics technologies to accelerate and overcome these challenges are reviewed.  Strategies to leverage innovation and technology for rapid product development and increasing productivity are discussed.  Specific examples are provided, as well as emerging technologies, such as continuous manufacture.

9:00am - 9:30am 30 mins
Info
Pre-Conference Symposia - 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

The iSKID™ biotherapeutic production platform under development at Boehringer Ingelheim is currently based on a perfusion reactor continuously loading permeate of variable product titer onto a Protein A column, the periodic elution of which undergoes further purification steps to bulk drug substance. Real-time titer measurement has been identified as a key PAT need, as variable titer means that periodic measurement is necessary to achieve a target column loading density. This talk will discuss the benefits and drawbacks of current available technologies, e.g. inline absorbance measurement, online Protein A UPLC, Raman, and refractive index.

9:00am - 9:30am 30 mins
Pre-Conference Symposia - Cell & Gene Therapy Bioprocessing
Challenges in the Manufacture, Release, and Distribution of Cell Therapy Products
  • Prentice Curry - Vice President, Quality and Compliance, Kite Pharma, USA
9:30am - 10:00am 30 mins
Pre-Conference Symposia - Continuous and Intensified Bioprocessing
Prevention & Removal of Contamination in an Open Environment during Continuous Processing
  • Raquel Orozco - Senior Bioprocess Engineer, Process Science , Boehringer Ingelheim Fremont, Inc. USA
9:30am - 10:00am 30 mins
Info
Pre-Conference Symposia - PAT and Advanced Process Control
A Review of Online Sampling in Pfizer Biotherapeutics
  • Keith Davis - Principle Scientist, Analytical R&D, Pfizer

History of Online Sampling in Pfizer Biotherapeutics Research and Development. Online Sampling in Pfizer Biotherapeutics Research and Development. Online Sampling in Pfizer Biotherapeutics clinical and commercial manufacturing. Future directions

9:30am - 10:00am 30 mins
Pre-Conference Symposia - Cell & Gene Therapy Bioprocessing
TBA
10:00am - 10:30am 30 mins
Pre-Conference Symposia - Continuous and Intensified Bioprocessing
Improving Fed-Batch using Process Intensification
  • Ruchika Bandekar - Associate Scientist II, Medimmune
10:00am - 10:30am 30 mins
Pre-Conference Symposia - PAT and Advanced Process Control
Sponsorship Talk
10:00am - 10:30am 30 mins
Pre-Conference Symposia - Cell & Gene Therapy Bioprocessing
TBA
10:30am - 11:15am 45 mins
Pre-Conference Symposia - Microbial Production
Morning Coffee Break and Networking
10:30am - 11:15am 45 mins
Pre-Conference Symposia - Continuous and Intensified Bioprocessing
Morning Coffee Break and Networking
10:30am - 11:15am 45 mins
Pre-Conference Symposia - PAT and Advanced Process Control
Morning Coffee Break and Networking
10:30am - 11:15am 45 mins
Pre-Conference Symposia - Cell & Gene Therapy Bioprocessing
Morning Coffee Break and Networking
11:15am - 12:15pm 60 mins
Info
Pre-Conference Symposia - Microbial Production
Microbial Manufacturing
  • Developing a Roadmap to Perform Effective Scale Up in Microbial Manufacturing  

  • Developing and Validating Process Monitoring and Control Technologies for Robust Monitoring of Microbial Production 

11:15am - 11:45am 30 mins
Info
Pre-Conference Symposia - Continuous and Intensified Bioprocessing
Case Study – USP Intensified Perfusion & DSP Purification Application: Round Table
  • Table 1 Priscilla Ngo - Scientist I, Boehringer Ingelheim
  • Table 2 Peter Satzer, PhD - Post-doctoral Researcher, University of Natural Resources and Life Sciences

Table 1: Time and Economic Benefits of Intensified Perfusion Process over Fed-Batch

  1. An intensified perfusion process of 14 days, fitting into existing GMP facility scheduling timelines interchangeably with fed-batch processes
  2. Productivity per liter of intensified perfusion bioreactor is many-fold greater than the current fed-batch process for the same molecule
  3. Improvement in cost per gram using intensified perfusion vs fed-batch
  4. Improvement in COGs using intensified perfusion vs fed-batch

Table 2: Robust Units, Constant Product Mass Flow and How Alternative Purification Methods Can Achieve Both for Antibody Production 

  1. - Direct integration of unit operations without hold tanks and the compatibility of current unit operations
  2. - Constant Mass Flow through unit operations, truly continuous constant inflow and constant outflow
  3. - Residence time distribution and robustness of operations and the trade-off between the two in continuous manufacturing
  4. - Alternative technologies for mAb purification, Precipitation, Crystallization, and Flocculation providing constant mass flow
11:15am - 12:15pm 60 mins
Info
Pre-Conference Symposia - PAT and Advanced Process Control
The Chemometrics of PAT & Avoiding Excel Hell: Round Table:
  • Table 2 Betty Tso - Cell Culture & Upstream Engineer, Bayer

Table 1: Update on Computer Software Techniques & Data Handling 

Table 2: Streamlining Analytics in a Time Saving Manner 


11:15am - 11:45am 30 mins
Pre-Conference Symposia - Cell & Gene Therapy Bioprocessing
New platforms for T cell bioprocessing
  • Shashi Murthy, PhD - Professor of Chemical Engineering & Sherman Center Director, Northeastern University
11:45am - 12:15pm 30 mins
Info
Pre-Conference Symposia - Continuous and Intensified Bioprocessing
Introduction to Novel Modalities & Continuous Bioprocessing: A Look at Antibody Drug Conjugates
  • Daniel Milano - Senior Development Engineer III, Immunogen
  • Continuous conjugation processes utilizing chemical flow reactors are capable of generating ADCs with comparable product quality to traditional batch processes
  • Space-time optimization for increased yield of continuous conjugation processes can maximize productivity while minimizing equipment footprint and requirements for containing highly potent compounds.
  • Single-pass tangential flow filtration (TFF) enables continuous ADC purification and formulation for end-to-end drug substance manufacturing.
11:45am - 12:15pm 30 mins
Pre-Conference Symposia - Cell & Gene Therapy Bioprocessing
Strategies to Increase Cell Culture Productivity: Scaling Up hMSC Bioreactor Culture
  • Katrina Adlerz - Scientist, RoosterBio Inc.
12:15pm - 12:45pm 30 mins
Pre-Conference Symposia - Microbial Production
Developing and Validating Process Monitoring and Control Technologies for Robust Monitoring of Microbial Production
  • Cameron Bardliving - Assistant Professor of Bioprocessing, Keck Graduate Institute
12:15pm - 12:45pm 30 mins
Pre-Conference Symposia - Continuous and Intensified Bioprocessing
Design of a Custom Continuous Process for Vaccine Formulations
  • Kirsten Strahlendorf - Senior Scientist, Sanofi Pasteur
12:15pm - 12:45pm 30 mins
Info
Pre-Conference Symposia - PAT and Advanced Process Control
Mapping Future Technology Needs for Real-Time Release Testing
  • Udayanath Aich, Ph.D. - Principal Scientist, Bioanalytics, Sanofi-Genzyme

Real time monitoring and in-time release of products create a demand to move testing from QC release (off-line) analysis to the manufacturing shop floor (in-line, on-line or at-line monitoring) in order to address Biopharmaceutical manufacturing goals of reducing speed, cost and maximizing quality of product. BioPhorum published a Biomanufacturing Technology Roadmap in July 2017 with the active collaboration of Biopharma industry representatives and supply partners. As part of implementation of roadmap strategy, BioPhorum's ILM-RTR technical forum team is developing a URS to prioritize most desired CQA’s, RMA and CPP focusing on the critical control points and future requirements of real time release (RTR). The URS document to be published in Q2 2019 will promote effective development of desired short, mid and long term technologies by the innovators and supply partners.

12:15pm - 12:45pm 30 mins
Pre-Conference Symposia - Cell & Gene Therapy Bioprocessing
TBA
12:45pm - 2:00pm 75 mins
Pre-Conference Symposia - Microbial Production
Lunch and Networking
12:45pm - 2:00pm 75 mins
Pre-Conference Symposia - Continuous and Intensified Bioprocessing
Lunch and Networking
12:45pm - 2:00pm 75 mins
Pre-Conference Symposia - PAT and Advanced Process Control
Lunch and Networking
12:45pm - 2:00pm 75 mins
Pre-Conference Symposia - Cell & Gene Therapy Bioprocessing
Lunch and Networking
2:00pm - 2:30pm 30 mins
Info
Pre-Conference Symposia - Microbial Production
Optimizing Expression of an Antibody Fab Fragment in Escherichia Coli with Non-Native Amino Acid (NNAA) Incorporated by Strain Engineering and Process Development
  • Harun Rashid - Senior Principal Scientist, Ambrx

In this study, expression of a ‘difficult-to-express’ (DTE) antibody Fab fragment with a non-native amino acid (NNAA) incorporated was systematically optimized by plasmid and strain engineering combined with process development. The various beneficial genetic components were then put together into a final production strain resulting in significant improvement in Fab expression titer over the starting strain.

2:00pm - 2:30pm 30 mins
Pre-Conference Symposia - Continuous and Intensified Bioprocessing
Hybrid Approach versus Fully Continuous
  • Michael Sokolov - Postdoctoral Fellow and Lecturer, ETH Zurich
2:00pm - 2:30pm 30 mins
Pre-Conference Symposia - PAT and Advanced Process Control
Process Control Strategies and Describing the Critical Parameters for Product Quality When Making mAbs
  • Dejan Arzensak - Research Scientist, Novartis
2:00pm - 2:30pm 30 mins
Pre-Conference Symposia - Cell & Gene Therapy Bioprocessing
Adopting Various Manufacturing Closed Systems to Gene Modified T Cell Therapies
  • Ali Mohamed - VP, CMC, Immatics, USA
2:30pm - 3:00pm 30 mins
Info
Pre-Conference Symposia - Microbial Production
Continuous Manufacturing of Secreted Proteins in High Cell Density Perfusion Cultures of Yeast Pichia Pastors Cells
  • Dhinakar Kompala - Founder & CEO, Sudhin Biopharma Company

We have developed a novel compact cell settler that reduces significantly the footprint of our previously developed “inclined settlers”, which have been proven in high cell density perfusion bioreactor cultures of CHO cells at the commercial scale.  With the more efficient settling performance of our compact settler, we have now demonstrated for achieving high cell densities of yeast Pichia pastoris cells, overexpressing a secreted protein and developed a continuous manufacturing process for any secreted protein from yeast.

2:30pm - 3:00pm 30 mins
Info
Pre-Conference Symposia - Continuous and Intensified Bioprocessing
PAT & The Roadmap to IPC & RTRT for Continuous Biomanufacturing
  • Richard Wu, PhD - Principal Scientist, Amgen

By beginning with the end in mind, the result of pharmaceutical product/process development should lead to robust manufacturing of drug substance and drug product processes with acceptable control strategies that ensure the performance of the drug product with positive patients’ experiences.  We will start with quality target product profile (QTPP) of desired pharmaceutical product and will demonstrate an example process analytical technologies (PAT) design to enable real-time monitoring of product quality attribute during its production.  Also, a roadmap to achieve real-time product attribute monitoring and control and to reduce COGM and fast material disposition with real-time release testing (RTRT) will be demonstrated.  Business considerations and technical requirements for the endeavors will be discussed.

2:30pm - 3:00pm 30 mins
Pre-Conference Symposia - PAT and Advanced Process Control
PAT & The Roadmap to IPC & RTRT for Continuous Biomanufacturing
  • Richard Wu, PhD - Principal Scientist, Amgen
2:30pm - 3:00pm 30 mins
Pre-Conference Symposia - Cell & Gene Therapy Bioprocessing
Closed Systems/Automation
  • Ohad Karnieli, Ph.D., MBA - CEO, Atvio Biotech
3:00pm - 3:30pm 30 mins
Pre-Conference Symposia - Microbial Production
Afternoon Coffee Break
3:00pm - 3:30pm 30 mins
Pre-Conference Symposia - Continuous and Intensified Bioprocessing
Afternoon Coffee Break
3:00pm - 3:30pm 30 mins
Pre-Conference Symposia - PAT and Advanced Process Control
Afternoon Coffee Break
3:00pm - 3:30pm 30 mins
Pre-Conference Symposia - Cell & Gene Therapy Bioprocessing
Afternoon Coffee Break
3:30pm - 4:00pm 30 mins
Pre-Conference Symposia - Microbial Production
Best Practice Model for Collaborative End to End Process Development and Manufacturing using P. Pastoris
  • Stefan Krahulec - Senior Manager Technology & Innovation, Boehringer Ingelheim RCV GmbH & Co KG
  • Iskandar Dib - Principal Scientist Process Development & Analytics, VALIDOGEN
3:30pm - 4:00pm 30 mins
Info
Pre-Conference Symposia - Continuous and Intensified Bioprocessing
Challenges and benefits of early stage process development for integrated continuous biomanufacturing processes
  • Aleksandar Cvetkovic - Head of Continuous Manufacturing Skill Center, Sanofi

Integrated Continuous Biomanufacturing (ICB) by integrating perfusion and multi-column capture provides strategic advantages for therapeutic protein production through process intensification, CoG reduction and simplification. As ICB becomes more accepted in industry, companies are beginning to investigate when ICB should be introduced in the process development cycle. Challenges and benefits of introducing ICB in early stage process development will be discussed.

3:30pm - 4:00pm 30 mins
Pre-Conference Symposia - PAT and Advanced Process Control
TBA
  • Michael Sokolov - Postdoctoral Fellow and Lecturer, ETH Zurich
3:30pm - 4:00pm 30 mins
Pre-Conference Symposia - Cell & Gene Therapy Bioprocessing
Session Wrap Up & End of Day Q&A
4:30pm - 5:00pm 30 mins
Info
Pre-Conference Symposia - Microbial Production
KEYNOTE ADDRESS: Fully Integrated Continuous Manufacturing v2.0 – Leveraging Lessons Learned and Technologies to Meet Evolving Biopharma Needs
  • Jens Vogel, Ph.D. - President & CEO, Boehringer Ingelheim Fremont Inc
  • Biopharma markets are evolving through the duality of precision medicines and novel blockbusters, requiring flexible manufacturing approaches
  • Continuous Manufacturing v2.0 will complement, and may one day disrupt, established fed batch manufacturing
  • Traditional challenges of continuous perfusion, such as high media volumes, can be overcome
  • Full integration and automation beats “fully continuous”
  • Our platform maximizes robustness and flexibility in multi-product settings
4:30pm - 5:00pm 30 mins
Info
Pre-Conference Symposia - Continuous and Intensified Bioprocessing
KEYNOTE ADDRESS: Fully Integrated Continuous Manufacturing v2.0 – Leveraging Lessons Learned and Technologies to Meet Evolving Biopharma Needs
  • Jens Vogel, Ph.D. - President & CEO, Boehringer Ingelheim Fremont Inc
  • Biopharma markets are evolving through the duality of precision medicines and novel blockbusters, requiring flexible manufacturing approaches
  • Continuous Manufacturing v2.0 will complement, and may one day disrupt, established fed batch manufacturing
  • Traditional challenges of continuous perfusion, such as high media volumes, can be overcome
  • Full integration and automation beats “fully continuous”
  • Our platform maximizes robustness and flexibility in multi-product settings
4:30pm - 5:00pm 30 mins
Info
Pre-Conference Symposia - PAT and Advanced Process Control
KEYNOTE ADDRESS: Fully Integrated Continuous Manufacturing v2.0 – Leveraging Lessons Learned and Technologies to Meet Evolving Biopharma Needs
  • Jens Vogel, Ph.D. - President & CEO, Boehringer Ingelheim Fremont Inc
  • Biopharma markets are evolving through the duality of precision medicines and novel blockbusters, requiring flexible manufacturing approaches
  • Continuous Manufacturing v2.0 will complement, and may one day disrupt, established fed batch manufacturing
  • Traditional challenges of continuous perfusion, such as high media volumes, can be overcome
  • Full integration and automation beats “fully continuous”
  • Our platform maximizes robustness and flexibility in multi-product settings
4:30pm - 5:00pm 30 mins
Info
Pre-Conference Symposia - Cell & Gene Therapy Bioprocessing
KEYNOTE ADDRESS: Fully Integrated Continuous Manufacturing v2.0 – Leveraging Lessons Learned and Technologies to Meet Evolving Biopharma Needs
  • Jens Vogel, Ph.D. - President & CEO, Boehringer Ingelheim Fremont Inc
  • Biopharma markets are evolving through the duality of precision medicines and novel blockbusters, requiring flexible manufacturing approaches
  • Continuous Manufacturing v2.0 will complement, and may one day disrupt, established fed batch manufacturing
  • Traditional challenges of continuous perfusion, such as high media volumes, can be overcome
  • Full integration and automation beats “fully continuous”
  • Our platform maximizes robustness and flexibility in multi-product settings
5:00pm - 6:00pm 60 mins
Pre-Conference Symposia - Microbial Production
Sponsored Dinner (and/or) Reception
5:00pm - 6:00pm 60 mins
Pre-Conference Symposia - Continuous and Intensified Bioprocessing
Sponsored Dinner (and/or) Reception
5:00pm - 6:00pm 60 mins
Pre-Conference Symposia - PAT and Advanced Process Control
Sponsored Dinner (and/or) Reception
5:00pm - 6:00pm 60 mins
Pre-Conference Symposia - Cell & Gene Therapy Bioprocessing
Sponsored Dinner (and/or) Reception