Presentations from Top Biopharma

Below is a sample of the 2023 top biopharma presentations.


Methods Used to Identify, Quantitate, and Monitor High-Risk Host Cell Proteins
Georgeen Gaza-Bulseco, Principal Research Scientist, AbbVie

Predictive Nature of High-Throughput Assays in ADC Formulation Screening
Siyuan Ren, PhD, Senior Scientist I, Global Pharmaceutical R&D, AbbVie Inc.


Current Challenges in Bioprocessing
Glen R Bolton, PhD, Executive Director, Late Stage Bioprocess Development, Amgen Inc.

MAD7 Nuclease Activity in CHO Cells
Geneva Alok, PhD, Process Development Scientist, Amgen

Enabling Global Operations with Realtime Sensing: A Case Study in Digital Product Management
Cylia Chen, Director, Business Performance, Amgen
Brian McBreen, Director, Digital Product Management – Sensing, Amgen

In the Patient’s Hands: In-Use Compatibility Testing and Strategies
Jennifer Litowski, PhD, Principal Scientist, Drug Product Technologies, Amgen, Inc.

Phase-Appropriate and State-of-the-Art Approaches for Developing High-Dose Subcutaneous Drug Products
Shantanu V. Sule, PhD, Principal Scientist, Amgen, Inc.

Identification and Mitigation of a Host Cell Protease That Cleaved a Therapeutic Protein
Gang Xiao, MSc, Senior Scientist, Process Development, Amgen, Inc.


Analytical Strategies for Gene Therapies
Lauren M. Drouin, PhD, Director, Analytical Development, Genomic Medicine, Alexion, AstraZeneca Rare Disease

Automation in Cell Line Development
Lina Chakrabarti, PhD, Assoc Principal Scientist, AstraZeneca

Cell Therapy Process Development and Manufacturing
Jerry Eriksson, PhD, Senior Research Scientist, AstraZeneca R&D

Which Program Is Not Accelerated? Increasing Efficiencies in Process Development for Speed, Quality, and Safety
Gisela M. Ferreira, PhD, Director, AstraZeneca

Formation of Transient Highly-Charged mAb Clusters Resulted in Poor Clearance of Host Cell Proteins during Downstream Processing
Haibin Luo, PhD, Associate Director, AstraZeneca


PAT and Automation for Robust Upstream Stem Cell Processing
Jens Traenkle, PhD, Head, PAT & Automation, Product Supply, Pharmaceuticals, Bayer AG

Digitalization – Another Technology?
Oliver Hesse, Head, Biotech Data Science & Digitalization, Bayer U.S. LLC


Improving the Throughput of a Very Low Throughput Method (CE-SDS) for Purity Analysis of mAb and AAV Samples
Andy Blum, Scientist, Biogen

AAV Purification: History, Current Practices, Challenges, and Solutions
Richard Ding, PhD, Head, Purification Process Development, Gene Therapy, Biogen

Evaluating the Impacts of Dual Salts and Organic Modifiers on Purification of Antisense Oligonucleotide via Anion Exchange Chromatography
Armin Delavari, PhD, Scientist II, Technical Development, Biogen

Plasmid Purification Process Development for Gene Therapy Applications
Jacob C. Cardinal, Associate Scientist III, Biogen

Increase the Depth and Breadth of Host Cell Protein Analysis through Analytical Method Innovation and Digital Tools
Rachel Chen, PhD, Associate Director, Analytical Development, Biogen

Host Cell Protein Analysis of AAV-Based Gene Therapy Products by LC-MS
Yue (Emma) Zhang, PhD, Scientist, Analytical Development, Biogen

Accelerated Raman Development for Implementation at Large-Scale
Kurtis Denny, Engineer I, Cell Culture Development, Biogen

End-to-End Development of a Suspension Transient Transfection Gene Therapy Production Platform
Terrence Dobrowsky, PhD, Head, Gene Therapy Drug Substance, Biogen

Evaluating Filter Chemistry as a Lever for Improving Perfusion Performance
Alexandria Triozzi, Engineer I, Biogen

Expanding Assay Robustness with Computer Vision
George Van Den Driessche, PhD, Lab Data Scientist, Biogen

Bristol Myers Squibb

Dual-Detection Approach for Charge Variant Analysis of Monoclonal Antibody Combination Products Using Imaged Capillary Isoelectric Focusing
Xue (Shelly) Li, Associate Director, Biologics Development, Bristol Myers Squibb Co.

Media Optimization for Robust CHO Cell Culture Process
Jianfa Ou, PhD, Senior Scientist, Bristol Myers Squibb Co.

Overcoming Supply Chain Challenges for Various Filters Used in Commercial Biologics Downstream Manufacturing
Elizabeth Pontius, BSc, Associate Engineer/Scientist, MSAT, Bristol Myers Squibb Co.

Computational Modeling of Protein A Resin Slurry in a Mixing Tank
Chadakarn Sirasitthichoke, PhD, Process Engineer, MS&T Process Analytics and Engineering, Bristol Myers Squibb Co.

Developing High-Productivity Mixed-Mode CHT Chromatography Purification Step for Complex Biologics
Patrick Staaf, Associate Scientist, Late Stage Process Development, Bristol Myers Squibb

A Spiking-Augmentation Method to Improve the Prediction Performance of FTIR-Titer Model on New Molecules
Yuxiang Zhao, PhD, Scientist, Bristol Myers Squibb Co.

Eli Lilly

Analysis of Critical Quality Attributes for AAV Products Using Mass Spectrometry
Zhirui (Jerry) Lian, PhD, Senior Director, Eli Lilly and Company


Choosing the Right Method: LC-MS/MS Based HCP Workflows and Case Studies for Process-Specific Method Development
Jia Guo, PhD, Principal Scientist, Analytical Development & Quality Control, Genentech, Inc.

Affinity Chromatography Mass Spectrometry – A Function-Structure-Based Approach for Streamlined Critical Quality Attribute Assessment of Biotherapeutics
Steffen Lippold, PhD, Postdoctoral Researcher, Protein Analytical Chemistry, Genentech

Characterizing the Stability and Its in vitro/in vivo Translatability of Novel Large Molecule Modalities Using Complementary Bioanalytical Tools
Cong Wu, PhD, Senior Scientist, Biochemical & Cellular Pharmacology, Genentech, Inc.


Evaluation of a Silicone-Free Syringe and Stopper Presentation for Use in Biopharmaceutical Drug Product Development
Caitlyn Sofa, Principal Scientist, GlaxoSmithKline

Sequence Engineering to Improve the "Syringeability" of High-Concentration Monoclonal Antibody Formulations
Georgina Armstrong, PhD Student, Senior Scientist, BioPharm Process Research, Drug Substance Development, GSK

PAT Deployment in GSK Vaccine from R&D to Manufacturing
Antonio G. Cardillo, PhD, Scientific Lead Associate Director, TRD-DS Global Innovation Centre, GSK Vaccines

Use of Biophysical Techniques and Other Predictive Parameters during Late Phase Formulation Development of Drug Products
Alejandro D'Aquino, PhD, Principal Investigator, GSK

Process Modeling for Ultrafiltration and Formulation
Poonam Phalak, PhD, Associate Director & Process Modeling Lead, GSK

Miniaturisation of High-Concentration Stability Studies
Lasse Stach, PhD, Principal Investigator & Leader, Developability Profiling Team, GSK


Investigations of a Bispecific Antibody Dimerization via Hydroxyl Radical Footprinting
Harsha Gunawardena, PhD, Senior Scientist, Mass Spectrometry, Janssen Pharmaceutical Companies of Johnson & Johnson

Increasing the Throughput of Process Development Analytical Studies
Hirsh Nanda, PhD, Director, Analytical Sciences, Janssen

Upper Concentration Limits of mAb Therapeutics – Strategies for High-Concentration (>200mg/ml) Drug Products
Ian Roy, Scientist, Formulation, Janssen R&D

Johnson & Johnson

In silico-Based Design of High-Concentration Protein Formulation
Maral Adeli Koudehi, PhD, Scientist, Drug Product Development, Johnson & Johnson


Case Studies of HCP Analytical Method Bridging and Phase-Appropriate Validation
Rosalind Ang, PhD, Associate Principal Scientist, Merck

It All Starts with One Vial: Cell Banking to Enable GMP Manufacturing
Charu Garg, PhD, Senior Scientist, Process Cell Sciences, Merck

Fed-Batch Fermentation AMBR250 Model Establishment and Its Utilization in Vaccine Development
Zhiguo Liu, PhD, Senior Scientist, Merck

Transition of Multi-Attribute Method (MAM) to GMP for Biotherapeutics
Shawn Li, PhD, Principal Scientist, Analytical Research and Development (AR&D) Mass Spectrometry, Merck & Co., Inc.

Fed-Batch Fermentation AMBR250 Model Establishment and Its Utilization in Vaccine Development
Zhiguo Liu, PhD, Senior Scientist, Merck

Sustainable Biologics Manufacturing – Current State and Future Outlook
Sri Madabhushi, PhD, Associate Principal Scientist & Associate Director, Merck

Development of a Simplified Scaled-Down Model for Characterization of a Multi-Column Continuous Protein A Operation
Lauren D. Powers, Senior Scientist, Merck

Characterizing Silicone Oil Migration and Its Impact on Biologic Drug Product in Prefilled Syringes
Xi Zhao, PhD, Senior Scientist, Sterile and Specialty Products, Merck


Implementation of N-1 Perfusion in Production of Biologics
Rok Brisar, PhD, Head of Tactical Manufacturing, Novartis

Characterizing CARs from the Cell Surface Using Immunoprecipitation-Mass Spectrometry
Nicolle Serrano SantoDomingo, Research Scientist II, Novartis

Pfizer Inc.

Application of Physics-Informed Neural Networks in Real-Time Cell Culture Bioreactor Modeling
Huiyi Cao, PhD, Senior Scientist, Pfizer Inc.
Shu Yang, PhD, Senior Scientist, Pfizer Inc.

High-Throughput mRNA Integrity Analysis and mRNA Fragment Characterization
Gaofei He, PhD, Principal Scientist, Pfizer Inc.

Applying an mRNA Vaccine Platform and New Developments to Next-Generation Products
Nicole Schiavone, PhD, Principal Scientist, Pfizer Inc.

Commercializing Gene Therapies
Vesselin Mitaksov, PhD, Associate Research Fellow, Global Biologics, Pfizer Inc.

Pfizer's Targeted Integration Platform Enables Development of Robust and Stable Cell Lines on Accelerated Timelines
Laura Zielewicz, PhD, Senior Scientist, Pfizer Inc.


Advancing Digital and Data Infrastructure for Bioprocess Development
Jun Huang, PhD, Senior Director, Preclinical Manufacturing and Process Development, Regeneron Pharmaceuticals Inc.

A Journey through the Evolution of HCP Detection Methods: From Early Commercial ELISA Kits to Specific Assays
Nisha Palackal, PhD, Director, Protein Biochemistry, Regeneron Pharmaceuticals, Inc.

Middle-Up Analysis of Alternative-Format Molecules Using New MS Strategies
Timothy-Neil Tiambeng, PhD, Scientist, Regeneron Pharmaceuticals

Characterization of Therapeutic Antibody Charge Variants in Drug Development by Microfluidic Native Capillary Electrophoresis-Mass Spectrometry
Zhijie Abe Wu, PhD, Scientist, Analytical Chemistry, Regeneron Pharmaceuticals, Inc.

Analysis of Biologically-Relevant Concentrations of Therapeutic Host Cell Proteins through an Ultrasensitive Quantification Method Coupling Limited Digestion to ProteoMiner Technology
Hui Xiao, PhD, Senior Principal Scientist, Regeneron Pharmaceuticals, Inc.


Digital Innovation in Transforming Molecules of Today into the Medicines of Tomorrow
Cenk Undey, PhD, Vice President & Global Head, PTD Data & Digital, Roche/Genentech


A Digital Transformation Journey in Process Development – Building Automated Data Flows, from Equipment to eLN to Advanced Analytics
Christian Airiau, PhD, Global Head, Data Sciences Biologics Development, Sanofi

Using High-Throughput Techniques to Improve Downstream Process Development for AAV
Arjun Bhadouria, PhD, Scientist, Purification Process Development, Genomic Medicine Unit CMC, Sanofi

Platform Approaches for a Diverse Pipeline: Engineering Ways of Working for Robust Separations
Kevin P. Brower, PhD, Global Head, Purification Process Development, Sanofi

Achieving High Titer in a Non-Platform CHO Process when Converting to an Internal Medium Platform
Thomas Hayes, BSE, Senior Scientist, Cell Culture Development, Sanofi

Characterization Methods for Vaccines
Marina Kirkitadze, PhD, Head Bioprocess Support & PAT Platform, Analytical Sciences, Sanofi Pasteur

Development and Optimization of a New Process to Maximize the Yield of Recombinant Hemagglutinin Production, a Component of Flublok Influenza Vaccine
Jamal Meghrous, PhD, Senior Scientist, Cell Culture & Production, Sanofi

Size Characterization of Vaccine Antigens: Ensemble vs. Single Particle Analysis Approach
Rahul Misra, PhD, Scientist, Biophysics and Process Analytical Technology, Sanofi

Formulation Development Considerations for AAVs
Paria Moxley, PhD, Scientist, Biologics Drug Product Development & Manufacturing, Sanofi

A New HeLaS3 Subclonal Cell Line for AAV Gene Therapy
Saurabh Sen, PhD, Associate Director, Cell Line Development, Genomic Medicine Unit CMC, Sanofi

Considerations and Challenges in Early LNP Development for Non-Viral Gene Therapy
Yuefei Shen, PhD, Principal Scientist, CMC Drug Product Development, Sanofi

How to Align the Definition of “Compendial Method” with Speed of Innovation?
Elena A. Smith, PhD, Analytical CMC Leader – Vaccine, Sanofi

Analyzing Structure/Function in Gene Therapy
McKay Wood, PhD, Senior Scientist, Analytical Development, Sanofi

NGS Technology Application in Genomic Medicine Unit of Sanofi
Wei Zhang, PhD, Senior Scientist, Sanofi

Takeda Pharmaceuticals

Development of a Platform Approach for the Affinity Capture and Characterization of Problematic Host Cell Proteins (HCPs)
Michael Dolan, Staff Engineer, Process Development US, Takeda Pharmaceuticals
Sunny Zhou, PhD, Professor, Chemistry & Chemical Biology, Northeastern University