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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 - 1:35pm 285 mins
Info
Seminar and Site Tour
Downstream Process Development Seminar and Boehringer Ingelheim Site Tour

Event Overview

Bio-Rad Laboratories and Boehringer Ingelheim invite you to attend this event at the Boehringer Ingelheim Campus.

A welcome introduction to Boehringer Ingelheim services and manufacturing facility will begin the morning agenda. We will discuss growing process development challenges in biomolecule purification, case studies, and new chromatography solutions to address these difficulties. We will conclude the seminar with a facility site tour and networking lunch.

This event will be held at Boehringer Ingelheim in Fremont, California.  A bus will transport you from BPI West Conference at the Hyatt Regency Santa Clara to and return to the hotel at approximately 1:30 pm.

Topics to be covered

  • Purification challenges for complex biomolecules
  • Case studies demonstrating benefits from new resin functionalities
  • Host cell protein clearance and control strategy
  • Global manufacturing network and technology platforms
  • Biopharmaceutical contract manufacturing
  • Boehringer Ingelheim Fremont site capabilities and biopharmaceutical track record


Registration Details  

  • This is a free event, a BPI US West conference registration is not required to attend (RSVP Here)
  • Registration includes round-trip transportation and networking lunch
  • Bus will depart the  Hyatt Regency Santa Clara on Monday, March 11th at 8:45 AM PST
  • Please send any inquiries to Process@bio-rad.com


Requirements 

Space is limited. Registration is required and includes transportation. A confirmation email will be sent to confirm your seat for this event.

8:50am - 9:00am 10 mins
Pre-Conference Symposia - Continuous and Intensified Bioprocessing
Chairperson’s Opening Remarks
  • Tony D'Amore, PhD, MBA - Vice President, Product Research and Development, Sanofi Pasteur
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.

9:20am - 9:30am 10 mins
Pre-Conference Symposia - PAT and Advanced Process Control
Chairperson’s Opening Remarks
  • Alessandro Butte, PhD - Senior Scientist and lecturer at ETH Zurich, Co-founder and CEO of DataHow, ETH Zurich
9:25am - 9:30am 5 mins
Pre-Conference Symposia - Microbial Production
Chairperson’s Opening Remarks
  • Cameron Bardliving - Assistant Professor of Bioprocessing, Keck Graduate Institute
9:25am - 9:30am 5 mins
Pre-Conference Symposia - Cell & Gene Therapy Bioprocessing
Chairperson’s Opening Remarks
9:30am - 10:00am 30 mins
Info
Pre-Conference Symposia - Microbial Production
Thought Leaders Discussion: Where Is, Microbial Production Going?
  • Stefan Krahulec - Senior Manager Technology & Innovation, Boehringer Ingelheim RCV GmbH & Co KG
  • Iskandar Dib - Principal Scientist Process Development & Analytics, VALIDOGEN
  • Where is, microbial production going?
  • Where do we see microbial hosts in the bioproduction space?
  • What technologies could change the market for microbial production?
  • What technologies and product advances are driving industry away from traditional CHO platforms?
  • Advantages, recent improvements and advances of microbial expression – yeast and E. coli
  • Microbial vs. Mammalian Expression:
  • Titres and Volumes
  • Impurity levels
  • Process timeframes
  • Product quality
  • Scalability
  • Process robustness
  • Tech transfer
  • Cost of Goods/ Production
  • Commercial development and production risk factors
  • Feasibility for integrated end to end continuous biomanufacturing
  • Developing platform approaches
9:30am - 10:00am 30 mins
Info
Pre-Conference Symposia - Continuous and Intensified Bioprocessing
Bioburden Strategy For An Integrated Manufacturing Platform at BI Fremont
  • Raquel Orozco - Senior Bioprocess Engineer, Process Science , Boehringer Ingelheim Fremont, Inc.

BI Fremont Inc and Pfizer are investing in intensified (continuous/integrated) processing to provide early stage clinical material radically cheaper and with little development, while keeping in mind a path to commercialization. Our processes is connects cell culture with purification steps, it is highly automated, reduces in-process pools, it is fully disposable, and it is GMP capable. The downstream system is designed to be scalable-in-place by changing column sizes, and buffer volumes-- enabling the ability to make up to 3kg of drug substance per day utilizing the same operational space. We have demonstrated the capability of purifying >2kg mAb of drug substance in in ≤15 days using 100 L bioreactor and are currently planning on scaling a 500L-scale GMP system.  The team has devised a comprehensive bioburden control strategy and generated data to support it. This talk will describe the iSKID integrated platform and the associated bioburden strategy.  

9:30am - 10:00am 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.

9:30am - 10:00am 30 mins
Pre-Conference Symposia - Cell & Gene Therapy Bioprocessing
Last minute cancellation - please move to another track
10:00am - 10:30am 30 mins
Info
Pre-Conference Symposia - Microbial Production
Development and Optimization of an Industrial and Scalable Fermentation Process for the Production of Recombinant CRM197 by E.coli
  • Marie-Anne Gauriat - Research Officer, National Research Council of Canada (CNRC)

Production of a soluble, functional and stable recombinant protein at high yields using microbial fermentation if often challenging. Strategies can involve development and optimization at different levels, from molecular biology (strain engineering, expression vector engineering, folding and stability improvements…) to fermentation (medium screening, limitation of by-products production, feed strategy…). Production of the toxoid Cross-Reacting Material 197 (CRM197), a mutated form of diphtheria toxin used as a carrier protein in conjugate vaccines, will be presented as a case study. The actual process has been developed for E. coli and results in the production of more than 5 g/L of soluble CRM197.

10:00am - 10:30am 30 mins
Info
Pre-Conference Symposia - Continuous and Intensified Bioprocessing
Raman Spectroscopy for Real-Time Process Monitoring in Upstream Bioprocessing
  • Nobel Vale - Research Scientist II, Bristol-Myers Squibb

Raman spectroscopy is a spectroscopic, RTA, and PAT technology that can be used in monitoring bioprocesses in real-time by creating predictive models.  This presentation will look at the evaluation of developing these models and show examples of the importance and benefits of real-time trending of data in fed-batch and continuous bioprocesses.  Evolution of this technology will enable development groups to further optimize their process in ways they were not able to in the past.

10:00am - 10:30am 30 mins
Info
Pre-Conference Symposia - PAT and Advanced Process Control
Raman Spectroscopy for Real-Time Process Monitoring in Upstream Bioprocessing
  • Nobel Vale - Research Scientist II, Bristol-Myers Squibb

Raman spectroscopy is a spectroscopic, RTA, and PAT technology that can be used in monitoring bioprocesses in real-time by creating predictive models.  This presentation will look at the evaluation of developing these models and show examples of the importance and benefits of real-time trending of data in fed-batch and continuous bioprocesses.  Evolution of this technology will enable development groups to further optimize their process in ways they were not able to in the past.

10:00am - 10:30am 30 mins
Pre-Conference Symposia - Cell & Gene Therapy Bioprocessing
Cell Therapy Global Launch: Lessons Learned
  • Prentice Curry - Senior Vice President Quality and Compliance, Kite Pharma, USA
10:30am - 11:15am 45 mins
Pre-Conference Symposia - Microbial Production
Morning Coffee Break and Networking
10:30am - 11:00am 30 mins
Pre-Conference Symposia - Continuous and Intensified Bioprocessing
Morning Coffee Break & 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
11:00am - 11:30am 30 mins
Info
Pre-Conference Symposia - Continuous and Intensified Bioprocessing
Case Study – USP Intensified Perfusion & DSP Purification Application: Round Table
  • Table 2 Peter Satzer, PhD - Post-doctoral Researcher, University of Natural Resources and Life Sciences
  • Table 1 Raquel Orozco - Senior Bioprocess Engineer, Process Science , Boehringer Ingelheim Fremont, Inc.

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 - 11:45am 30 mins
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
11:15am - 12:15pm 60 mins
Info
Pre-Conference Symposia - PAT and Advanced Process Control
Implementing PAT: Round Table
  • Table 2 Betty Tso - Cell Culture & Upstream Engineer, Bayer
  • Table 1 Nuno Pinto, Ph.D - Senior Scientist, Biologics Process R&D, Merck & Co., Inc.

Table 1: Automation & High Throughput Techniques 

Table 2: Development and Implementation of Robust Chemometric Models for an Inline Dielectric Spectroscopy Sensor in a Commercial Manufacturing Process

- Working principle of sensor and unique challenges of manufacturing process
- Definition of user requirements and chemometric model development process
- Challenges encountered throughout the model development
- Outcome and next steps


11:15am - 11:45am 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.
11:30am - 12:00pm 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
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.

11:45am - 12:15pm 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
12:00pm - 12:30pm 30 mins
Info
Pre-Conference Symposia - Continuous and Intensified Bioprocessing
Design of a Custom Continuous Process for Vaccine Formulations
  • Kirsten Strahlendorf - Senior Scientist, Sanofi Pasteur

Manual batch operations can lead to inefficiencies such as unnecessary storage, multiple batch record documents and manual tasks. Here we have designed, tested and run a continuous automation process to formulate a variety of complex vaccines in a closed, single-use setup. The system is inclusive of in-line monitoring sensors and feedback control to ensure quality product.

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
Info
Pre-Conference Symposia - PAT and Advanced Process Control
Mapping Future Technology Needs for Real-Time Release Testing
  • Udayanath Aich, Ph.D. - Associate Director, Bristol Myers Squibs

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
12:30pm - 1:00pm 30 mins
Info
Pre-Conference Symposia - Continuous and Intensified Bioprocessing
Virus Safety For Continuous Processing
  • Mark Schofield, Ph.D. - Principal R&D Engineer, Pall Biotech

Continuous bioprocessing is increasingly seen as a means to decrease the cost and increase the quality of biotherapeutics. However, moving to a continuous process raises regulatory concerns. A key regulatory requirement is the demonstration of virus safety. As biologics expressed in human or animal cell lines have a propensity for endogenous retrovirus expression and can experience adventitious viral contamination, both testing and clearance validation strategies are required. For mAb processes, specific virus clearance steps are included such as low pH inactivation and virus filtration. Additionally, chromatography steps are relied upon to fortify the clearance of the manufacturing process. Here we address virus safety for continuous processing holistically, providing performance data and potential validation strategies for virus safety via continuous chromatography, low pH inactivation and virus filtration.

Continuous chromatography is typically performed at faster flow rates than batch chromatography and protein is loaded closer to the static dynamic binding capacity rather than dynamic binding capacity. To assess the impact of these factors (residence time and loading capacity) on virus clearance, single column chromatography experiments were performed with bacteriophage to mimic mammalian viruses. These tests allow an evaluation of critical process parameters (CPP) for virus clearance by single column chromatography and forecast CPPs for virus clearance in continuous mode. The knowledge gained from these experiments enable us to operate the Protein A step in continuous mode whilst still maintaining expected levels of virus clearance.

Low pH virus inactivation is a key step for virus safety, but it is commonly performed manually with offline pH measurements. To address this, we have developed a full scale system for the semi-continuous low pH virus inactivation downstream of a 2000L bioreactor and the Cadence BioSMB. Here we show the strategy the system uses and data that supports key features of the approach. Additionally, we have developed a prototype scale down system for process development and we show data with that in a complete continuous process

Finally, continuous virus filtration is regarded as higher risk due to the low flux , extended durations and increased risk of process interruptions. By applying the principles of Quality by Design (QbD) and addressing the balance of convective forces vs. hindered diffusion of viruses, we demonstrate that the unique filter design space for continuous processing applications can be filled with new generation virus filters with unique pore structures and high permeabilities.

Together this data acts as a framework to maximize virus clearance in continuous bioprocesses, potential technology gaps to avoid and what factors to consider in the viral safety risk assessment.

12:45pm - 2:00pm 75 mins
Pre-Conference Symposia - Microbial Production
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
1:00pm - 2:00pm 60 mins
Pre-Conference Symposia - Continuous and Intensified Bioprocessing
Luncheon
2:00pm - 2:30pm 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
2:00pm - 2:30pm 30 mins
Pre-Conference Symposia - Continuous and Intensified Bioprocessing
Building model-based solutions for more PAT in bioprocessing - which data, expertise and software do I need?
  • Alessandro Butte, PhD - Senior Scientist and lecturer at ETH Zurich, Co-founder and CEO of DataHow, ETH Zurich
2:00pm - 2:30pm 30 mins
Pre-Conference Symposia - PAT and Advanced Process Control
Building model-based solutions for more PAT in bioprocessing - which data, expertise and software do I need?
  • Alessandro Butte, PhD - Senior Scientist and lecturer at ETH Zurich, Co-founder and CEO of DataHow, ETH Zurich
2:00pm - 2:30pm 30 mins
Pre-Conference Symposia - Cell & Gene Therapy Bioprocessing
Closed Systems/Automation
  • Ohad Karnieli, Ph.D., MBA - CEO, Atvio Biotech
2:30pm - 3:00pm 30 mins
Pre-Conference Symposia - Microbial Production
Session Wrap Up & End of Day Q&A
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
Info
Pre-Conference Symposia - PAT and Advanced Process Control
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 - Cell & Gene Therapy Bioprocessing
Session Wrap Up & End of Day Q&A
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 and Networking
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
  • William Napoli - Scientist, 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
Info
Pre-Conference Symposia - PAT and Advanced Process Control
A Review of Online Sampling in Pfizer Biotherapeutics
  • Keith Davis - Principal 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

4:00pm - 4:30pm 30 mins
Info
Pre-Conference Symposia - Continuous and Intensified Bioprocessing
Integrated Small-Scale End-to-End System for mAb Production In Process Development
  • Veronique Chotteau, PhD - Director of VINNOVA Competence Centre for Advanced BioProduction by Continuous Processing, AdBIOPRO and Principal Investigator, KTH - Royal Institute of Technology

An integrated small-scale system was created using minimal equipment: a 200 mL bioreactor for perfusion mode and a single lab-scale chromatography system (ÄKTA pure) for all the downstream steps (protein A capture, virus inactivation, cation exchange, anion exchange). In less than 4 hours, 0.8 g mAb/L/day was obtained from established steady-state showing consistent glycosylation and 5-log reduction of HCP.

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