2021 Top Pharma Presentations

The Bioprocessing Summit is a dynamic learning and networking event and your number one resource for the latest developments in the bioprocessing field. Participation by industry is stronger than ever, with more than 50 presentations and Q&A sessions from top pharma including AbbVie, Amgen, AstraZeneca, Biogen, Genentech, GSK, Merck, Pfizer, Sanofi, and more. Below is just a sample of what is to be presented.


Purification Approaches for Aggregation-Prone Antibody Fragment
Wan-Ching Lai, PhD, Senior Scientist, ADD, Abbott Labs

Development of a Practical Approach for Evaluation of Single Use Fermenters with Application in Diagnostic Industry
Yongxue Ding, PhD, Principal Scientist, Biologics Process Design R&D, Abbott Diagnostics Division, Abbott Laboratories


Implementing High-Throughput Tools for Lead Selection and Developability Analysis
Andrew K. Urick, PhD, Senior Scientist, AbbVie

A Novel Pirani-Flowrate Correlation Soft-Sensor to Enable PAT-Based Lyophilization Drying Endpoint Determination and Optimization
Tong Zhu, PhD, Senior Scientist, New Biological Entities (NBE) Pharmaceutical Sciences, AbbVie, Inc.


Methods for Measuring Protein Concentration: Comparison of Edelhoch Method with Other Methods
Dipanwita Batabyal, PhD, Process Development Scientist, Amgen, Inc.

Control Strategy Considerations for Ensuring Fit-for-Purpose Materials
Susan E. Burke, PhD, Director Process Development, Materials Science, Amgen, Inc.

Optimization of Host Cell Protein (HCP) Analysis by Nano LC-MS
Gang Xiao, MSc, Scientist, Process Development, Amgen, Inc.


Sensitive, Rapid, Robust, and Reproducible Workflow for Host Cell Protein Profiling in Biopharmaceutical Process Development
Jiao Ma, PhD, Scientist II, AstraZeneca

Development and Process Characterization of a Precipitation Step Using Sodium Caprylate for the Reduction of Host Cell Proteins
Jessica Prentice, Purification Process Sciences, BioPharmaceutical R&D, AstraZeneca, Gaithersburg, US

Lessons Learned from the Pandemic
Darrin Cowley, PhD, Vice President & Head, Developmental Quality Biologics, Quality Lead COVID Vaccine, AstraZeneca


Application of Machine Learning Methods to Pathogen Safety Evaluation in Biological Manufacturing Processes
Shyam Panjwani, PhD, Senior Data Scientist, Bayer Healthcare Pharmaceuticals


Speed, Cost, and Quality: Unlocking the Potential of Alternative Hosts for Biologics
Christina S. Alves, PhD, Head, Cell Line Development, Biogen

KEYNOTE PRESENTATION: Scale-Up of Continuous Antibody Manufacturing Process from Bench to Pilot Scale and Beyond
Alex Brinkmann, Senior Engineer II, Biopharmaceutical Development, Biogen

Using DoE Models in Process Development of Antisense Oligonucleotides
Armin Delavari, PhD, Scientist I, Technical Development, Biogen

Stability-indicating assays for AAV-based vectors
Marina S. Feschenko, PhD, Director, Gene Therapy, Biogen

Establishing an Automated Raman-Based Chemometric Model Development Platform
Daniel R. Hill, Manufacturing Scientist, Global Process Analytics, Biogen

Testing and Improving Antibody Developability during Candidate Discovery and Optimization
Mark C. Julian, PhD, Scientist I, Biologics Drug Discovery, Biogen

Control Strategy for Difficult to Remove HCPs in Biopharmaceutical Development
Suli Liu, PhD, Senior Scientist, Biogen

Modeling of Cell Culture Processes to Predict and Modulate Product Quality (CQAs)
Thomas Villiger, PhD, Senior Manufacturing Scientist, Biogen International GmbH

Improved qPCR Methods for AAV Genome Titer and Residual DNA Quantification
Yu Wang, PhD, Senior Scientist, Analytical Development, Biogen

Boehringer Ingelheim

Development of Novel Dynamic Perfusion Methodology with Compartmentalized Media Concentrates for Next-Generation Continuous Bioprocessing
Yiu-Sun (Sunny) Hung, PhD, Scientist II, Cell Culture, BIFI Process Science, Boehringer Ingelheim

Generic Hybrid Model for CHO Cultivation Processes to Predict Quality Attributes Across Different Biopharmaceutical Products
Liliana Montano Herrera, Postdoctoral Researcher, Bioprocess Development, Boehringer Ingelheim Pharma GmbH & Co. KG

Doing the Right Things Right: HCP Control Strategy for Biopharmaceuticals
Thomas Waerner, PhD, Associate Director & Project Manager, Analytical Development & Quality Control, Boehringer Ingelheim Pharma GmbH & Co. KG

Bioprocess Development at Pandemic Pace
Stefan Wieschalka, Scientist, Early Stage Bioprocess Development, Boehringer Ingelheim Pharma GmbH & Co. KG

Bristol-Myers Squibb

New Technologies for At-Line, On-Line and In-Line Process Monitoring
Ivie Aifuwa, PhD, Senior Scientist, Bristol-Myers Squibb Co.

In Silico Prediction of Physical and Chemical Stability of Biologics
Naresh Chennamsetty, Senior Principal Scientist, Bristol-Myers Squibb Co.

Correlation of Online and Offline Techniques to Measure CHO Cell Health for Early Detection and Control of Cell Stress
Kyle P. McHugh, PhD, Principal Scientist, Upstream Biologics Process Development, Bristol-Myers Squibb Co.

Online Capacitance Controlled Perfusion N-1: Optimization of Media Usage and Process Development Flow
Emily Rittershaus, PhD, Scientist, Process Development Upstream, Bristol-Myers Squibb Co.

Automation & Digitalization in High-Throughput Analytics for Bioprocess
Ruchir Shah, Scientist, Process Development Analytics, Bristol-Myers Squibb Co.

Multi-Attribute Chromatography for Bioprocess Monitoring
Helen Zhao, PhD, Associate Scientist II, Process Development Analytics, Bristol-Myers Squibb Co.

Chugai Pharmaceutical

Progress on Continuous Process Development Toward the Envisioned Next-Generation Factory Concept
Tomonori Shiotani, CMC Researcher, API Process Dev, Chugai Pharmaceutical Co Ltd


Pharmaceutical Development Strategies to Minimize Particles Resulting from Polysorbate Degradation
Nidhi Doshi, Scientist, Late Stage Pharmaceutical Development, Genentech Inc.

Toolkit for Profiling Low-Abundant Host Cell Proteins in Biotherapeutics
Midori Greenwood-Goodwin, PhD, Technical Development Scientist, Genentech, Inc.

Use of AI to Identify Sample Properties with Spectroscopy
Elvira Kadaub, Data Management Engineer, Genentech

Reducing Cell-Cell Aggregate Formation and Insulin Degradation in Culture Media
Shahram Misaghi, PhD, Senior Scientist, Cell Culture and Bioprocess Operations (CCBO), Genentech, Inc.

KEYNOTE PRESENTATION: Sustainability and the Future of Bioprocessing
Kristi Budzinski, PhD, Principal Product Stewardship & Green BioPharma Manager, Genentech, Inc.


Sample Preparation for High-Throughput Lead Selection
Phylicia Dassardo-Joseph, Scientific Investigator, Biopharm Discovery, GlaxoSmithKline

Digital Twin for Biotech Processes
Sandrine Dessoy, Senior Manager, Tech R&D, GlaxoSmithKline

Incorporating Mass Spectrometry into Biotherapeutic CMC Analytical Strategies
Matthew Maust, PhD, Investigator, GlaxoSmithKline

Analytical Method for Determination of Expression of a Secondary Element in the Transgene Cassette by RT-PCR
Carlos E. Peredo, PhD, R&D Associate Fellow, Cell and Gene Therapy Platform, GlaxoSmithKline

Establishment of a Walk-Up Fully Automated Ella Lab for CHO HCP Analysis
Kathleen Van Manen-Brush, PhD, Investigator, Structure & Function Characterization, GlaxoSmithKline

Janssen Pharmaceutical

Enabling Technologies for Mass Spectrometric Characterization of Biologics
Harsha Gunawardena, PhD, Senior Scientist, Mass Spectrometry, Janssen Pharmaceutical Companies of Johnson & Johnson

Novel Approach for Subvisible Particle Characterization of Biopharmaceuticals
Sravan Penchala, PhD, Senior Scientist, Biologics Drug Product Development, Janssen Pharmaceuticals, Inc.

Analytical Tools to Characterize Chemically Defined Media-Overview of Control Strategy to Control Chemical Contamination
Andrew Lewis, Senior Scientist, Biotherapeutics Development & Supply, Janssen R&D, LLC

Johnson & Johnson

Raman Deployment for Vaccine Production
Christopher Mahoney, PhD, Scientist, Advanced Process Control, Johnson & Johnson Pharmaceutical R&D


Impurities in Raw Materials
Kyle Devenney, MS, Scientist, Merck

High-Throughput, Efficacious Gene Editing & Genome Surveillance in Chinese Hamster Ovary Cells
Zhimei Du, PhD, Director, Biologics & Cell Therapeutics Process Development, Merck and Co., Inc.

Implementation of Custom Single-Use 2L Bioreactors in Upstream Process Developmen
Balrina Gupta, PhD, Associate Principal Scientist, Biological & Sterile Product Development, Merck Research Labs

Host Cell Protein Comparability Before and After Process Change by LC-MS Based Proteomics Method
Tingting Jiang, PhD, Senior Scientist, Merck & Co., Inc.

KEYNOTE PRESENTATION: 2+1: Tackling the Pandemic Using an Accelerated, Multi-Pronged Approach
David Maraldo, PhD, Vice President, Global Vaccines & Biologics Commercialization, Merck & Co., Inc.

Crystal Structure and Characterization of Human Heavy-Chain-Only Antibodies Reveals a Novel, Stable Dimeric Structure Analogous to mAbs
Carl Mieczkowski, PhD, Associate Principal Scientist, Protein Sciences, Merck Research Labs

Co-Formulation Development: Balancing Challenges and Opportunities in Formulation and Process Optimization
Ashlesha Raut, Senior Scientist, Biologics and Vaccine Formulation, Merck Research Labs

Plug and Play Automation for Bioprocessing
Eugene Tung, PhD, Executive Director, Manufacturing IT, Merck & Co., Inc.

BioPhorum Development Group (BPDG) HCP Working Stream Update
Fengqiang Wang, PhD, Principal Scientist, Analytical Method Development, Merck & Co., Inc.

Scale-down of Microbial Fermentation Process to 250mL Single Use Bioreactors to Enable Collection of Process Characterization Data
Matthew Woodling, Associate Principal Scientist, Vaccine Bioprocess R&D, Merck & Co Inc.


Plasmid DNA Starting Material Characterization
Lawrence C. Thompson, PhD, Senior Principal Scientist, Analytical R&D, Pfizer Inc.

Best Practices for Identification and Quantitation of HCP Impurities in Biological Products Using Mass Spectrometry – Update from USP Host Cell Protein Expert Panel
Ying Zhang, PhD, Principal Scientist, Analytical Research and Development, Pfizer Inc.

Regeneron Pharmaceuticals

Digitalization, Data Enablement and Analytics for Accelerated Bioprocess Development
Jun Huang, PhD, Senior Director, Data Enablement and Analytics, Regeneron Pharmaceuticals

Improved Host Cell Protein Analysis in Monoclonal Antibody Products through ProteoMiner Enrichment
Hui Xiao, Senior Staff Scientist, Regeneron Pharmaceuticals, Inc.

Identification, Validation and Clearance of Highly Active Host Cell Proteins Responsible for Rapid Polysorbate Degradation in Formulated Drug Product
Sisi Zhang, Lead Researcher, Regeneron Pharmaceuticals, Inc.


wNMR Analytics of Biologics: IPC or Release Analytics Done in Seconds!
Maximilian Hartl, PhD, Scientist & Lab Manager, Pharma Research & Early Development, Roche Diagnostics GmbH


Optimization of an AAV Harvest Platform to Accommodate Novel, Non-Conforming AAV Capsid Serotypes
Carlos A Benitez, MSEM, Scientist, Purification Process Development, Genomic Medicine Unit, Sanofi

Compiling an HCP Knowledge Repository
Michelle Busch, Scientist, Bioanalytics Characterization, Sanofi

KEYNOTE PRESENTATION: mRNA Vaccines: A Paradigm Shift in Pandemic Preparedness
Sudha Chivukula, PhD, Head, mRNA Technology, Sanofi Pasteur Biologics Co.

Implementation Strategy of a Next-Generation Sequencing Workflow
Jarrod Dean, PhD, Associate Director, Genomic Medicine Unit, Sanofi

Evaluation of the Erbi BreezTM Microbioreactor System
Jared Franklin, Principal Research Associate, Medium & Bioprocess Technologies, Sanofi US

In-Line Monitoring of Surfactant Clearance in Viral Vaccine Downstream Processing
Marina Kirkitadze, PhD, Head Bioprocess Support & PAT Platform, Analytical Sciences, Sanofi Pasteur

Method Development for Automation
Janna Liptak, Senior Research Associate, Bioanalytics, Sanofi Genzyme

Advanced Analytics for Virus-Based Gene Therapies
Shibani Mitra-Kaushik, PhD, Director & Head, Bioassay & Molecular Analytical Development, Genomic Medicine Unit, Sanofi

Development of Scale-Down Model to Evaluate Impact of Cavitation
Sanket Patke, PhD, Senior Scientist, Biologics Drug Product Development, Sanofi

Seasonal Saga: Critical Reagents for Influenza Vaccines
Elena A. Smith, PhD, Deputy Director Quality Analytical Expert, Quality, Sanofi Pasteur

Impact of Formulation Parameters on Efficacy of Common Chelators
Anvay Ukidve, PhD, Scientist, Formulation and Process Development, Sanofi


In silico Assessment of HCP Immunogenicity Risk
Christopher Gemski, Scientist I, Drug Metabolism & Pharmacokinetics, Takeda Pharmaceutical Co. Ltd.

Process Development and Analytical Approaches to Achieving Safety, Consistency and Quality of an Inactivated Zika Vaccine Candidate
Natraj Ram, PhD, Senior Director, Vaccine Process Development, Takeda

Host Cell Protein Profile Identification in a Cell Therapy Product Using LC/MS/MS Technique
Yiwei Zhao, PhD, Senior Scientist, Assay Development & Biochemistry, Takeda Pharmaceuticals

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