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Mar 14
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7:15am - 7:45am

Technology Workshops with Light Continental Breakfast

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Showing of Streams
Showing of Streams
9:50am - 10:20am

Networking Refreshment Break

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Showing of Streams
12:05pm - 1:25pm

Networking Luncheon

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Showing of Streams
3:00pm - 3:15pm

Conference Recap, Closing Remarks and Look Ahead to BPI West 2020

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7:15am - 7:45am 30 mins
Technology Workshops with Light Continental Breakfast
8:00am - 8:15am 15 mins
Single-Use Applications
Chairperson’s Opening Remarks
  • Jesse Knaub - Process Scientist, Upstream Operations, Biopharmaceutical Development, Pharmaceutical Science and Technology, Eisai Inc.
8:00am - 8:15am 15 mins
Early Stage Process Development
Chairperson’s Opening Remarks
  • Ravindra Pangule - Associate Principal Scientist, Merck & Co., Inc.,
8:00am - 8:15am 15 mins
Late Stage Process Development
Chairperson’s Opening Remarks
8:00am - 8:15am 15 mins
Commercial Manufacturing & Beyond
Chairperson’s Opening Remarks
8:00am - 8:15am 15 mins
Novel Technologies
Chairperson’s Opening Remarks
8:15am - 8:45am 30 mins
Info
Single-Use Applications
Evaluation, Implementation, and Process Scale-up to a 2000 L Single Use Bioreactor System
  • Jesse Knaub - Process Scientist, Upstream Operations, Biopharmaceutical Development, Pharmaceutical Science and Technology, Eisai Inc.

With the goal of expanding an existing clinical pilot plant into a commercial facility, a capital project was initiated to evaluate 2000 L single use bioreactor systems. Requisite to the chosen system was performance that is most comparable to the existing 1000 L stainless steel bioreactors within the pilot plant. During the evaluation, four systems were considered: the Thermo Single Use Bioreactor (S.U.B.), the Pall Allegro STR, the GE Xcellerex XDR, and the Sartorius Stedim Biostat STR. Of these systems, the Biostat STR was identified as most congruent with the existing stainless steel systems. Design and installation of the 2000 L Biostat STR offered significant advantages over traditional stainless steel bioreactor systems. The system offers a simplified mechanical design requiring no steam utilities or clean-in-place resulting in increased flexibility with lower capital investment as well as reduced financial and labor costs and shorter system turnaround times. After installation and qualification, the 2000 L Biostat STR system was used for manufacturing of a Phase 3 monoclonal antibody. Data from four bioreactor runs show comparable performance between the Biostat STR and the 1000 L stainless steel system that was used for Phase 2 manufacturing. Overall, the single-use 2000 L Biostat STR has provided a bioreactor platform with comparable performance to traditional stainless steel systems while offering increased operational efficiency and flexibility within the facility. 

8:15am - 8:45am 30 mins
Early Stage Process Development
Early Development Assessment Strategies to Predict Successful Molecules: A Case Study on Developability Assessment of Bispecific Molecules
  • Duc Nguyen, PhD - Lab Head, Novartis
8:15am - 8:45am 30 mins
Late Stage Process Development
The Role of Knowledge Management in Speed and Cost of Development – An Update from Biophorum Technology Roadmap Workstream on Knowledge Management
  • Bert Frohlich, Ph.D., - Director, Strategy and Technology Lifecycle, Manufacturing Sciences & Technology, Shire
8:15am - 8:45am 30 mins
Commercial Manufacturing & Beyond
The Role of Knowledge Management in Speed and Cost of Development – An Update from Biophorum Technology Roadmap Workstream on Knowledge Management
  • Bert Frohlich, Ph.D., - Director, Strategy and Technology Lifecycle, Manufacturing Sciences & Technology, Shire
8:45am - 9:15am 30 mins
Info
Single-Use Applications
“Sustainable Single-Use”: Oxymoron or Opportunity?
  • Mark Petrich - Director, Single-Use Systems Engineering, Merck & Co., Inc.

“Reduce-Reuse-Recycle” will be used as a framework for discussing the environmental and operational impacts of manufacturing, shipping, use, and disposal of single-use systems.  Full realization of the technical and environmental advantages of single-use technology requires that “end-of-life” concerns be addressed.  Examples of current sustainable practices and products, and ideas for future improvements will be presented.

8:45am - 9:15am 30 mins
Info
Early Stage Process Development
Rational Design and Early In-Silico Screening for Improved Biophysical Properties of Bispecific Antibodies
  • Patrick Farber, PhD - Senior Scientist, Zymeworks Inc

In the development of a bispecific antibody therapeutic, candidates are often chosen for their desired functional properties rather than their stability and manufacturability. This talk will describe the use of rational design of a bispecific antibody to improve properties including heterogeneity, stability, and purity. Additionally, I will present predictive in-silico developability techniques for early detection of liabilities that can affect biological function and homogeneity.

8:45am - 9:15am 30 mins
Late Stage Process Development
Manufacturing Continuous Process Improvement for Enhancing the Control Capability of Product Quality Attributes by Biopharmaceutical Product Process Validation Lifecycle
  • Ting-Kuo Huang, PhD - Senior Engineer, Genentech
8:45am - 9:15am 30 mins
Commercial Manufacturing & Beyond
Manufacturing Continuous Process Improvement for Enhancing the Control Capability of Product Quality Attributes by Biopharmaceutical Product Process Validation Lifecycle
  • Ting-Kuo Huang, PhD - Senior Engineer, Genentech
9:20am - 9:50am 30 mins
Info
Technology Workshops
Technology Workshop- Avid Case Study – Taking your molecule through process validation
  • Dave Briggs, PhD - Sr. Manager, Avid Bioservices, Inc.
  • William Leonardi, PhD - Project Manager, Avid Bioservices, Inc.

Due to the complexity of process validation, proper planning and organization are key to enable successful Biologic Licensing Application (BLA) submission.  Avid Bioservices has completed process validation for numerous clients.  This presentation will discuss Avid’s approach to process validation ranging from Process Characterization, Validation Master Plan, Process Performance Qualification, and the supporting activities required to support the BLA package submission.

9:20am - 9:50am 30 mins
Info
Technology Workshop 2
Technology Workshop: Efficient Protein Production Process in Mammalian Cells - Scale and Quality
  • Mark Fox, PhD - Director, ATUM (formerly DNA2.0)
9:20am - 9:50am 30 mins
Info
Technology Workshop 3
Next generation technologies that yield higher quality CHO clones and intensified gene to GMP timelines
  • Nigel Shipston, Ph.D - Director, Program Design, FUJIFILM Diosynth Biotechnologies

Directed evolution has been employed to identify host cell lines with desirable
biomanufacturing attributes

The combination of a new host cell line and new technology with the addition of an
improved cell culture medium and process has allowed a reduction in CLD time without
compromising quality

Multiple cell lines with > 10 g/L titres and acceptable critical product quality attributes

Recombinant cell lines exhibit changes in productivity and product quality infrequently

9:50am - 10:20am 30 mins
Networking Refreshment Break
10:25am - 10:30am 5 mins
Single-Use Applications
Chairperson's Remarks
10:25am - 10:30am 5 mins
Early Stage Process Development
Chairperson's Remarks
10:25am - 10:30am 5 mins
Late Stage Process Development
Chairperson's Remarks
10:25am - 10:30am 5 mins
Commercial Manufacturing & Beyond
Chairperson's Remarks
10:30am - 11:00am 30 mins
Info
Single-Use Applications
Building a robust integrity assurance strategy for single-use systems to enhance product security, patient and operator safety.
  • Elisabeth Vachette - Head of PM Bags/Mixing/Tanks, Sartorius Stedim Biotech
  • Carole Langlois - Marketing Manager-Traditional Vaccines, Sartorius Stedim Biotech FMT SAS

Key objective: This presentation describes the integrity assurance strategy of a single use manufacturer with a case study illustrating the validation of real-world and laboratory testing for handling and shipping of drug substances using ASTM most stringent standard shipping simulation studies.


Abstract: With the expansion of Single Use Systems (SUS) in all process steps of commercial manufacturing and today’s global bio-manufacturing network consisting of multiple production sites,  integrity failure can significantly impact drug safety, availability and costs. Consequently, there is an increasing industry scrutiny on single use container integrity (SU CCI), raising the need to build robust integrity strategies. Indeed, the increased responsibility of SU manufacturers in the supply of a turnkey or off-the-shelf SUS make the assurance of integrity a shared responsibility between the supplier and the end-user.


The authors will first review the emerging industry association’s initiatives and introduce the integrity assurance strategy of a single use suppliers. The presentation will describe the foundations of product robustness and how integrity testing with meaningful detection limits can enhance the product security, patient and operator safety for SUS used in sterile manufacturing.


The authors will conclude by describing an integrated validation approach that establishes the safety factor for the standardized test methods vs. real liquid shipping conditions in single use bags. The data from a four-step qualification study using a novel protocol with a mix of standards ASTM, ISO, EN norms. The study contributes to the robustness of the overall supplier qualification and provides a strong basis to predict the expected performance under real-world conditions.

10:30am - 11:00am 30 mins
Info
Early Stage Process Development
Smart Model-Based Digital Solutions for Early Bioprocess Development
  • Alessandro Butte, PhD - Senior Scientist and lecturer at ETH Zurich, Co-founder and CEO of DataHow, ETH Zurich
  • Model-assisted screening and scale-up for biosimilar process development
  • Smart software for sequential experimental design and process optimization
  • Smart spectroscopy-based sensors for online process monitoring and real time adaptive process optimization in USP and DSP
  • Smart robotic platforms for automated highthroughout bioprocess development
10:30am - 11:00am 30 mins
Late Stage Process Development
Efficient Integration of CPV with the Annual Product Report
  • Barry Pearson, MSc - Principle Scientist, Drug Product Technologies, Amgen Inc.
  • Carly Cox - Process Informatics Manager, Global Engineering, Pfizer
  • Guillermo Gambero, Ph.D. - Process Scientist, Technical Services, Pfizer
10:30am - 11:00am 30 mins
Commercial Manufacturing & Beyond
Efficient Integration of CPV with the Annual Product Report
  • Barry Pearson, MSc - Principle Scientist, Drug Product Technologies, Amgen Inc.
  • Carly Cox - Process Informatics Manager, Global Engineering, Pfizer
  • Guillermo Gambero, Ph.D. - Process Scientist, Technical Services, Pfizer
10:30am - 10:50am 20 mins
Info
Novel Technologies
Breaking data silos in process development: delivering batch data to multivariate analysis in 30s
  • Timothy Gardner, PhD - CEO, Riffyn, Inc.

Today's breakthroughs lie deep in the midst of complex, multivariate data sets. Experimental anomalies and fundamental discoveries often go unnoticed because they are buried in uninterpretable spreadsheets, inaccessible databases, or excessive experimental noise. The cloud-based Riffyn software structures and links experimental designs and measurement data for analysis within seconds after it is collected. Riffyn is helping bioprocessing organizations use this capability to identify unexpected correlations, uncover root causes of error, and deliver right-first-time technology scale-up and technology transfer.


10:50am - 11:10am 20 mins
Info
Novel Technologies
Closing the loop in bioprocessing with connected lab automation and data integration
  • Markus Gershater - Chief Scientific Officer, Synthace

We show how software can be used to unlock the analytics bottleneck in upstream bioprocessing in both traditional biologics and cell and gene therapies. The automation of off-line assays, and their integration with online data streams will unlock more robust processes and facilitate a move towards full design space automation.

11:00am - 11:35am 35 mins
Info
Single-Use Applications
PANEL DISCUSSION: Insight on risk mitigation in Single-Use Systems
  • Michael Tucker - Product Compliance Specialist, Watson-Marlow Fluid Technology Group

Key topics of discussion include:

  • Integrity of the single use system
  • Cleanliness of system components
  • Continuous processing
  • Process validation – what information do end-users require from suppliers to use single use equipment in their drug processing
  • Dual sourcing – current practices to secure business continuity
11:00am - 11:35am 35 mins
Info
Early Stage Process Development
A User Requirement Specification for new Harvest Clarification technology for High Density Cell Cultures
  • Ashley Hesslein - Associate Director, Bayer

Increasing operational cell densities will generate new challenges around harvest clarification. The BioPhorum Global Technology Roadmap identified the need for new, robust harvesting systems that enable more cost-effective upstream processing options, e.g. handling high-density suspensions. Improvements in this field are expected to lead to higher harvest cell densities (>150^6 cells/mL) and substantially reduced downtimes within a 10-year horizon.  

The benefits of new harvest technology; 

  • Precludes a bottleneck at the clarification stage as upstream process utilise higher density cultures. 

 

  • Reduces footprint for Cell Harvest facility 

 

  • Reduce pressure on biomanufacturing utilities needs and waste management 

 

  • Increase Robustness/Performance/Ease of Use. 

The presentation describes the URS created through a collaboration of biomanufacturers and suppliers facilitated by BioPhorum. 

11:00am - 11:35am 35 mins
Late Stage Process Development
Panel Discussion: Interdisciplinary Perspectives on Maximizing the Interplay Between Late Stage and Commercial Manufacturing
  • Natraj Ram, Ph.D. - Associate Director, Purifiaction, Manufacturing Sciences, AbbVie Inc.
  • Tom Tonussi - Lead Bioprocess Engineer, IPS-Integrated Project Services
11:00am - 11:35am 35 mins
Commercial Manufacturing & Beyond
Panel Discussion: Interdisciplinary Perspectives on Maximizing the Interplay Between Late Stage and Commercial Manufacturing
  • Natraj Ram, Ph.D. - Associate Director, Purifiaction, Manufacturing Sciences, AbbVie Inc.
  • Tom Tonussi - Lead Bioprocess Engineer, IPS-Integrated Project Services
11:35am - 12:05pm 30 mins
Single-Use Applications
Please move to another track.
11:35am - 12:05pm 30 mins
Early Stage Process Development
Early Stage
11:35am - 12:05pm 30 mins
Info
Late Stage Process Development
Microbial Identification via DNA-Sequencing Method to Support Risk Mitigation Strategies
  • Anna Carr - Customer Service and Sales Manager, Infinity Laboratories

The utilization of Microorganism Identification through DNA sequencing provides an in depth and comprehensive view of the variety of organisms that may pose a risk to controlled environments or final product. Discussion of standards requiring characterization/identification and techniques of a genotypic microbial identification method will be covered.

11:35am - 12:05pm 30 mins
Info
Commercial Manufacturing & Beyond
Microbial Identification via DNA-Sequencing Method to Support Risk Mitigation Strategies
  • Anna Carr - Customer Service and Sales Manager, Infinity Laboratories

The utilization of Microorganism Identification through DNA sequencing provides an in depth and comprehensive view of the variety of organisms that may pose a risk to controlled environments or final product. Discussion of standards requiring characterization/identification and techniques of a genotypic microbial identification method will be covered.

12:05pm - 1:25pm 80 mins
Networking Luncheon
1:25pm - 1:30pm 5 mins
Single-Use Applications
Chairperson’s Opening Remarks
1:25pm - 1:30pm 5 mins
Early Stage Process Development
Chairperson’s Opening Remarks
1:25pm - 1:30pm 5 mins
Late Stage Process Development
Chairperson’s Opening Remarks
1:25pm - 1:30pm 5 mins
Commercial Manufacturing & Beyond
Chairperson’s Opening Remarks
1:25pm - 1:30pm 5 mins
Novel Technologies
Chairperson’s Opening Remarks
1:30pm - 2:00pm 30 mins
Single-Use Applications
Internal Alignment of Standards and Best Practices Enabling Rapid Low-Cost Deployment of Single Use
  • Jeffrey Johnson - New Technology Lead and Director, Global Engineering Solutions, Merck & Co., Inc.
1:30pm - 2:00pm 30 mins
Info
Early Stage Process Development
Upstream Strategies to Address Process & Quality Challenges Associated with Molecules of New Modality
  • Ravindra Pangule - Associate Principal Scientist, Merck & Co., Inc.,

Molecules of new modality with unique molecular architecture, multispecificity, and multivalency, represent an attractive alternative to monoclonal antibodies.  However, the novel nature and limited understanding may warrant for extensive development work to resolve potential process and product quality challenges associated with such molecules.  In this presentation, two such case studies will be presented, with the focus on strategies designed to address product quality challenges that would be atypical for a standard platform antibody.

1:30pm - 2:00pm 30 mins
Late Stage Process Development
Internal Alignment of Standards and Best Practices Enabling Rapid Low-Cost Deployment of Single Use
  • Jeffrey Johnson - New Technology Lead and Director, Global Engineering Solutions, Merck & Co., Inc.
1:30pm - 2:00pm 30 mins
Commercial Manufacturing & Beyond
Internal Alignment of Standards and Best Practices Enabling Rapid Low-Cost Deployment of Single Use
  • Jeffrey Johnson - New Technology Lead and Director, Global Engineering Solutions, Merck & Co., Inc.
2:00pm - 2:30pm 30 mins
Info
Early Stage Process Development
Issues with Glycoproteins: a Case Study
  • Andrew Mathison - Scientist, Biologics Process Design, Abbott Laboratories
Andrew Mathison, Carol Ramsay, Bryan Tieman, Janet Bergsma, Ryan Bonn, Troy McSherry, Jeff Fishpaugh, Steven Allen

While the production of recombinant fusion proteins in mammalian systems can offer significant benefits including increased potency and ease of manufacture, this approach is not without its issues.  The recombinant fusion glycoprotein ABBOTT, an Fc fusion expressed in CHO cells, exhibited extreme aggregation issues after purification with Protein A chromatography.  After further polishing by Gel Filtration Chromatography, the protein had lower than expected potency as determined by the Biacore assay.  When this “pure” population was further purified by Anion Exchange Chromatography, an extremely heterogenous charge population was uncovered.  These charge differences were shown by Mass Spectrometry to be due to differences in glycosylation.  The increasing glycosylation appears to negatively impact molecule potency without impacting structure until it becomes so significant that it leads to structural changes and aggregation.  Changes in construct and/or expression system may be required to produce an active form of this molecule at scale. 

2:30pm - 3:00pm 30 mins
Single-Use Applications
Biophorum - Suppliers and Bio-Manufacturers Accelerating the Application of Single Use Technologies Through Collaboration
  • Todd Andrews - Global Sales and Business Development Manager, Bioprocessing, CPC - Colder Products Company
  • Trishna Ray-Chaudhuri, PhD - Senior QC Associate II, Genentech, Inc.
2:30pm - 3:00pm 30 mins
Info
Early Stage Process Development
Developing A Robust Downstream Process For Early Phase ADC Manufacturing Under Tight Timelines
  • Chi Zhang, PhD - Scientist, Ambrx, Inc.

 Ambrx’s technology to incorporate a non-natural amino acid at a precise position allows the generation of homogenous conjugates.  In order to rapidly deliver our ADC pipeline, developing a robust downstream process of the mAb purification through conjugation of the ADC is vital.  Drawing from experiences gained from Ambrx’s first clinical ADC candidate, ARX788, the strategies of overcoming the challenges for the downstream development of the second ADC candidate is described.

2:30pm - 3:00pm 30 mins
Late Stage Process Development
Biophorum - Suppliers and Bio-Manufacturers Accelerating the Application of Single Use Technologies Through Collaboration
  • Todd Andrews - Global Sales and Business Development Manager, Bioprocessing, CPC - Colder Products Company
  • Trishna Ray-Chaudhuri, PhD - Senior QC Associate II, Genentech, Inc.
2:30pm - 3:00pm 30 mins
Commercial Manufacturing & Beyond
Biophorum - Suppliers and Bio-Manufacturers Accelerating the Application of Single Use Technologies Through Collaboration
  • Todd Andrews - Global Sales and Business Development Manager, Bioprocessing, CPC - Colder Products Company
  • Trishna Ray-Chaudhuri, PhD - Senior QC Associate II, Genentech, Inc.
3:00pm - 3:15pm 15 mins
Conference Recap, Closing Remarks and Look Ahead to BPI West 2020