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BioProcess International US West
March 9-11, 2026
San Diego Convention CenterSan Diego, CA, USA
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Wednesday March 11 - PT (Pacific Time, GMT-08:00)

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Wednesday March 11 - PT (Pacific Time, GMT-08:00)
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Showing 1 of 1 Streams
8:00am - 8:55am
Registration and Morning Coffee
Showing 5 of 5 Streams
8:55am - 9:00am
Chairperson's Opening Remarks: Cell Line Development & Engineering
9:00am - 9:30am
Accelerating Cell Line Development Timelines from Discovery to Clinic
  • Elizabeth H. Scheideman PhD. - Staff Scientist, Vaccine Production Program, VRC, NIAID,, NIH
9:30am - 10:00am
Advanced Cell Line Development Technologies for High-Speed and Flexible Host Gene Modulation
  • Thomas Jostock, Ph.D. - Associate Director, Novartis
10:00am - 10:30am
Great Bay Bio
8:55am - 9:00am
Chairperson's Opening Remarks: Cell Culture & Upstream Processing
9:00am - 9:30am
High-Density CHO Cell Cultures as an Alternative to Perfusion for Productivity Enhancement
  • Hiren Panchal - Principal Investigator, Incyte
9:30am - 10:00am
Implementation of a perfusion seed vessel to increase cell mass as well as optimize feed composition and strategy
  • Manos Tzortzakakis - Scientist, Cell Culture and Fermentation Sciences, AstraZeneca
10:00am - 10:30am
Sponsored Talk
8:55am - 9:00am
Chairperson's Opening Remarks: Manufacturing Strategy & Bioprocessing 4.0
9:00am - 9:30am
Topic to be Determined
  • Michael Coolbaugh - Head of Advanced Manufacturing Implementation, Sanofi
9:30am - 10:00am
Integrating Continuous Manufacturing: A Practical Roadmap
10:00am - 10:30am
Abzena
8:55am - 9:00am
Chairperson's Opening Remarks: Recovery & Purification
9:00am - 9:30am
The Redox Reaction for Multispecifics
  • Dawn Ericksen-Stapleton - Principal Scientist, Pfizer
9:30am - 10:00am
Development of on-demand affinity chromatography using rabbit single-chain Fv antibodies
  • Yoichi Kumada, Ph.D. - Professor, Kyoto Institute of Technology
10:00am - 10:30am
Cytiva
8:55am - 9:00am
Chairperson's Opening Remarks: Cell & Gene Therapy Production & Commercialization
9:00am - 9:30am
Scaling genome-edited allogeneic CAR-T manufacturing to increase access to cell therapies
  • Engineering strategies for allogeneic CAR-T cell therapies for improved safety and efficacy
  • Increasing scale of allogeneic cell therapies without compromising quality
  • Improving access to CAR-T therapy with off-the-shelf products


  • Justin Scoble, Ph.D. - Vice President of Technical Operations, Caribou Biosciences, Inc.
9:30am - 10:00am
Engineering Next Generation CAR T cell
  • CAR T requires enhancement for improving efficiency
  • T cell Engager as an enhancing feature of CAR T cells
  • Rapid manufacturing of RNA based CAR T
  • Magdi Elsallab, Ph.D., MD - Director of Process Development, Massachusetts General Hospital
10:00am - 10:30am
Sponsored Talk
Showing 1 of 1 Streams
10:30am - 11:15am
Morning Networking Break in Exhibit Hall
Showing 5 of 5 Streams
11:15am - 11:45am
Accelerated mAb cell line development via bulk pool optimization
  • Shu Wang, Ph.D. - Principal Investigator, Incyte
11:45am - 12:15pm
Building Speed into Cell Line Development: Lessons from Accelerated Clinical Programs at BMS
  • Whitney Liu - Principal Scientist, Bristol Myers Squibb
12:15pm - 12:45pm
Sponsored Talk
11:15am - 11:45am
Process Intensification Using HIPDOG for BCAT1-Knockout CHO Cell Culture
  • Aleah Li - Senior Scientist, Pfizer
11:45am - 12:15pm
Pushing Cell Culture Productivity Limits
  • Megan Menzel - Process Development Engineer I, Regeneron
12:15pm - 12:45pm
Sponsored Talk
11:15am - 11:45am
Maximizing CMC Efficiency through In-house AD/PD Optimization for External Tech Transfers
  • Discuss the challenges of external tech transfers when outsourcing CDMOs for clinical manufacturing.
  • How to condense timelines and reduce costs through in-house utilization of AD/PD teams to perform parallel development with external partners.
  • Strategies to identify and mitigate risks for allogeneic therapies.
  • Isaura (Alex) Villalba - Senior Research Associate, Tr1X Bio
11:45am - 12:15pm
Reimagining Operational Excellence in Biomanufacturing for the Next Decade
  • A Representative from Biophorum, BioPhorum
12:15pm - 12:45pm
Sponsored Talk
11:15am - 11:45am
The Role of Digitalization and Data-Driven Optimization on Downstream Processing
  • Stefano Menegatti, Ph.D. - Professor, Chemical and Biomolecular Engineering, NC State University, North Carolina State University
11:45am - 12:15pm
Implementing Digital Twins to Support Real-Time Release in DSP
12:15pm - 12:45pm
Sponsored Talk
11:15am - 11:45am
From Bench to BLA: Critical Attributes of AAV Vector Manufacturing Process Development
  • This talk will discuss critical attributes of AAV process development to bridge the gap for BLA and long-term commercial success.
  • We will highlight key development differences among AAV vector manufacturing platforms, highlighting focus on development strategies for productivity, purity and safety.
  • This presentation will offer actionable insights for BLA readiness in advancing AAV gene therapy products.
  • Mukesh Mayani - Senior Director, Ultragenyx
11:45am - 12:15pm
Case Study Gene Therapy – Manufacturing Process Improvement and Scale Up to Reduce Costs and Enhance Efficiency
  • Anthony Chikere, Ph.D. - Director, Process Development, Sangamo
12:15pm - 12:45pm
Sponsored Talk
Showing 1 of 1 Streams
12:45pm - 2:00pm
Luncheon in Exhibit Hall
Showing 5 of 5 Streams
2:00pm - 2:30pm
How Early Integration of CLD and Process Development Reduces Risk and Supports Faster, Reliable Scale Up
  • Saurabh Sen - Head of Cell Line Production, Cell Line Development Mammalian Platform (Biologics), Sanofi
2:30pm - 3:00pm
Real-World Examples of Reducing Scale-Up Challenges Through Early, Integrated Development Efforts
  • A Representative From Amgen - ., Amgen
2:00pm - 2:30pm
Adapting CHO Platforms for Viral Vector Production
  • A Representative from A*STAR - Process Development, A*STAR
2:30pm - 3:00pm
Topic to be Determined
  • Venkata Tayi, Ph.D. - Senior Principal Scientist, Director, Merck
2:00pm - 2:30pm
Keynote Address - Achieving Supply Chain Resilience in Bioprocessing
  • Paul Hanson - Head of Lifecycle Management, Innovation, and Strategy, Interim Head of, Business Excellence, Global Manufacturing Sciences, Takeda Pharmaceuticals
2:30pm - 3:00pm
Topic to be Determined
  • Jim Fries - CEO, RX-360
2:00pm - 2:30pm
Purification of GLP-1 Peptide Products
2:30pm - 3:00pm
Ensuring Viral Safety in AAV9 Gene Therapy Program: Potentially Platformable Approach that Delivers Robust Clearance
  • Srivatsan Ramesh, Ph.D. - Scientist, BridgeBio Gene Therapy
2:00pm - 3:00pm
Supply Chain and Contingency Planning for Critical Materials of mRNA Therapeutics and Vaccines
  • Mukunda Krishna - Associate Director, External Manufacturing, Tech Ops and Supply Chain, Arcturus Therapeutics
3:00pm - 3:30pm
Improving the Cell Therapy Supply Chain
Showing 1 of 1 Streams
3:30pm - 4:15pm
Afternoon Break in Exhibit Hall
Showing 5 of 5 Streams
4:15pm - 4:45pm
Modulation of Fucosylation by Cell Line Engineering
  • Afucosylation control strategies are being embedded into platform workflows for biologics development, enabling early intervention or post-initiation modulation.
  • Overexpression of certain enzymes in glycosylation pathway in CHO cells consistently modulates afucosylation levels across diverse clones and molecular formats, demonstrating a robust and scalable strategy for glycoform modulation.”


  • Arathi Krishnakumar, Ph.D. - Scientific Associate Director, Bristol Myers Squibb
4:45pm - 5:15pm
Comparative Studies on Various MS Methods and Software Tools for HCP Analysis - Valuable Conclusions Regarding Practical Applications
  • Jing Wang, Ph.D. - Senior Scientist, Regeneron
5:15pm - 5:45pm
Panel Discussion: Ensuring Cell Line Quality and Stability from Development to Manufacturing

Best practices for maintaining genetic stability and ensuring consistent quality. Panelists will discuss digital monitoring and AI-enabled risk prediction across development to commercial stages.

4:15pm - 4:45pm
Process Characterization Case Study
  • Raquel Orozco - Director, Abcuro
4:45pm - 5:15pm
Standardizing Raw Material Characterization for Regulatory Acceptance
  • Zvi Kelman, Ph.D. - Director, Biomolecular Labeling Laboratory, NIST
5:15pm - 5:45pm
Achieving Upstream Supply Chain Resilience
  • Katherine Resch - Process Characterization & Technology Scientist, Regeneron
4:15pm - 4:45pm
Topic to be Determined
  • Ken Hamilton - Director of Process Engineering, Genentech
4:45pm - 5:15pm
Integrated Purification and Formulation: Enabling High-Concentration, Stable Drug Products
  • Robert Mayer, Ph.D. - Lab Lead, MS&T, Novartis Pharmaceutical Manufacturing GmbH
5:15pm - 5:45pm
Panel Discussion – The Next Decade in Biomanufacturing Strategy

A visionary panel on trends shaping the future: decentralized production, autonomous operations, evolving supply chains, and end-to-end continuous processes. Panelists will explore how digital and AI-enabled systems will define the next decade.

  • Vilas Shukla, Ph.D. - Director, Large Molecule Global Engineering Projects, Johnson & Johnson Innovative Medicine
4:15pm - 4:45pm
Product Sustainability Strategy – Addressing Environmental Impact Across the Product Lifecycle
  • Ashley Kongs - Environmental Sustainability Director – Supply Biologics, AstraZeneca
4:45pm - 5:15pm
From Antibodies to RNA: Intensification Case Studies for the Future of Bioprocessing
  • Intensification strategies can transform biologics manufacturing, delivering both sustainability and cost-of-goods (CoGs) benefits.
  • Case studies across antibodies and and RNA demonstrate how intensification can be applied to different product types.
  • Intensification is not only about technical gains – it underpins more resilient, commercially viable, and environmentally responsible bioprocessing.
  • Philip Probert, Ph.D. - Director of Biologics and RNA CoE, CPI
5:15pm - 5:45pm
Panel Discussion – The Future of Downstream Processing

A forward-looking discussion on how continuous processing, single-use technologies, and AI/ML-enabled purification will transform downstream operations by 2030. Leaders will examine the convergence of sustainability, automation, and supply chain resilience as drivers of the next generation of biomanufacturing.

  • Philip Probert, Ph.D. - Director of Biologics and RNA CoE, CPI
4:15pm - 4:45pm
Next-Generation Formulation Approaches for CGT Products

Presentations on innovative formulations, cryopreservation, and vector stabilization. Talks will highlight predictive modeling and data analytics for stability and manufacturability.

4:45pm - 5:15pm
Quality-by-Design for CGT Formulations: Linking DP Attributes to Clinical Handling
  • James Warren - Senior Vice President, Ultragenyx
5:15pm - 5:45pm
Panel Discussion: Preparing for Commercialization of Advanced Therapies

Panelists will discuss scaling CGT processes for launch, including validation, comparability, COGS, and supply chain readiness. Focus on digital readiness for regulatory filings and scale-up.

Showing 1 of 1 Streams
5:45pm - 5:50pm
Close of Conference
Tuesday March 10
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