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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
9:50am - 10:20am

Networking Refreshment Break and Grand Opening of the Exhibit & Poster Hall

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

Networking Luncheon in the Exhibit & Poster Hall

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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
8:00am - 8:15am 15 mins
Early Stage Process Development
Chairperson’s Opening Remarks
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
Sponsorship Opportunity
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
Utilising Process Modelling and Advanced Analytics in Early Process Development
8:15am - 8:45am 30 mins
Late Stage Process Development
Development Perspectives – Implementation of New Techniques/Technologies
  • Katherine Chaloupka - Principal Engineer, Amgen
8:15am - 8:45am 30 mins
Commercial Manufacturing & Beyond
Development Perspectives – Implementation of New Techniques/Technologies
  • Katherine Chaloupka - Principal Engineer, Amgen
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
Early Stage Process Development
Implementation of Advanced Analytical Methods in Early Stage Process Development
8:45am - 9:15am 30 mins
Late Stage Process Development
Cell Culture Manufacturing Continuous Process Improvement: Enhancing the Control Capability of Product Quality Attributes for Marketed Biopharmaceutical Product Lifecycle
  • Ting-Kuo Huang, PhD - Senior Engineer, Genentech
8:45am - 9:15am 30 mins
Commercial Manufacturing & Beyond
Cell Culture Manufacturing Continuous Process Improvement: Enhancing the Control Capability of Product Quality Attributes for Marketed Biopharmaceutical Product Lifecycle
  • Ting-Kuo Huang, PhD - Senior Engineer, Genentech
9:20am - 9:50am 30 mins
Single-Use Applications
Technology Workshop
9:20am - 9:50am 30 mins
Early Stage Process Development
Technology Workshop
9:20am - 9:50am 30 mins
Late Stage Process Development
Technology Workshop
9:20am - 9:50am 30 mins
Commercial Manufacturing & Beyond
Technology Workshop
9:50am - 10:20am 30 mins
Networking Refreshment Break and Grand Opening of the Exhibit & Poster Hall
10:30am - 11:00am 30 mins
Single-Use Applications
Design and Implementation of Robust, Reliable, Real Time Sensor Technologies for Disposable Manufacturing
10:30am - 11:00am 30 mins
Early Stage Process Development
Cell Culture Media Development and Feed Optimisation to Enhance Product Quality and Productivity
10:30am - 11:00am 30 mins
Late Stage Process Development
How These Improvements Impacted Quality and Comparability
  • Amanda Ashcraft - Director, Sanofi
10:30am - 11:00am 30 mins
Commercial Manufacturing & Beyond
How These Improvements Impacted Quality and Comparability
  • Amanda Ashcraft - Director, Sanofi
11:00am - 11:30am 30 mins
Single-Use Applications
Quality Control of Single Use Systems to Ensure Supply Chain Security
11:00am - 11:30am 30 mins
Info
Early Stage Process Development
A User Requirement Specification for new Harvest Clarification technology for High Density Cell Cultures

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 - 11:30am 30 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.
11:00am - 11:30am 30 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.
11:30am - 12:00pm 30 mins
Single-Use Applications
Sponsored Scientific Track Presentations
11:30am - 12:00pm 30 mins
Early Stage Process Development
Sponsored Scientific Track Presentations
11:30am - 12:00pm 30 mins
Late Stage Process Development
Sponsored Scientific Track Presentations
11:30am - 12:00pm 30 mins
Commercial Manufacturing & Beyond
Sponsored Scientific Track Presentations
12:05pm - 1:25pm 80 mins
Networking Luncheon in the Exhibit & Poster Hall
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
Sponsorship Opportunity
Chairperson’s Opening Remarks
1:25pm - 1:30pm 5 mins
Hands on Training Course
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, Center for BioManufacturing Sciences, 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
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, Center for BioManufacturing Sciences, Merck & Co., Inc.
2:00pm - 2:30pm 30 mins
Single-Use Applications
Alternative Materials and Construction to Compete with Existing Stainless Steel Technologies – What’s Out There? What are the Challenges? What’s the ROI for Each?
  • Adam Goldstein - Principal Scientist, Roche
2:00pm - 2:30pm 30 mins
Early Stage Process Development
Overcoming the Issues Observed With Early Stage Production Of Glycoproteins
  • Andrew Mathison - Scientist, Biologics Process Design, Abbott Laboratories
2:00pm - 2:30pm 30 mins
Commercial Manufacturing & Beyond
Alternative Materials and Construction to Compete with Existing Stainless Steel Technologies – What’s Out There? What are the Challenges? What’s the ROI for Each?
  • Adam Goldstein - Principal Scientist, Roche
2:30pm - 3:00pm 30 mins
Single-Use Applications
Single Use Systems Integration in Existing Commercial Manufacturing Facilities
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
Commercial Manufacturing & Beyond
Single Use Systems Integration in Existing Commercial Manufacturing Facilities
3:00pm - 3:15pm 15 mins
Conference Recap, Closing Remarks and Look Ahead to BPI West 2020