2022 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 60 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 will be presented.


Challenges and Adventures in Purification Development for a Novel Diabody
Jian Ren, PhD, Senior Scientist II, AbbVie


Developing High Dose Biologics – Scaling the Cliffs and Beyond
Shantanu V. Sule, PhD, Principal Scientist, Amgen, Inc.

FEATURED PRESENTATION: Impact of Stress Factors in Primary Packaging, Transportation, and Handling of Protein Drug Products
Christian Twinkle, MS, Sr. Scientist, Amgen

Characterization of a Host Cell Protein that Causes Product Cleavage by Nano LC-MS
Gang Xiao, MSc, Senior Scientist, Process Development, Amgen, Inc.


KEYNOTE PRESENTATION: A Truly Continuous Counter-Current Downstream
Jonathan L. Coffman, PhD, Senior Director, Bioprocess Technology & Engineering, AstraZeneca

KEYNOTE PRESENTATION: Analytical Support for Accelerated Development Timelines
Stephan O. Krause, PhD, CMC Strategy Director, Global Quality, AstraZeneca Biologics


KEYNOTE PRESENTATION: Phased Approach to Establishing Production Platforms
Terrence Dobrowsky, PhD, Head, Gene Therapy Drug Substance, Biogen

Single-Protein Immunoassays for Detection of Hitchhiker HCPs
Cullen Mason, PhD., Associate Director, Technical Development, Biogen

Bench to Scale-Up of a Next-Gen High-Capacity Protein A Resin for Continuous Manufacturing
Maria Znidarsic, Engineer I, Downstream Development, Biogen
Jennifer Zhang, Senior Engineer, Biogen

Boehringer Ingelheim Pharma

Assessing Methods for Low Abundant HCP Detection
Thomas Waerner, PhD, Associate Director & Project Manager, Analytical Development & Quality Control, Boehringer Ingelheim Pharma GmbH & Co. KG, Germany

Bristol Myers Squibb

The Mitigation of Lipase Risk in a Bispecific Antibody Downstream Process
Haiying Bao, Principal Scientist, Bristol Myers Squibb Co.

Operationalization of the Digitized Biomanufacturing Facility – An Integrated Approach
Scott Clark, Associate Director, Data Intelligence & Analytics – Global Biologics, Bristol Myers Squibb Co.

FEATURED PRESENTATION: Method Development Strategy for Release Methods
Akshata Ijantkar, Senior Scientist, Analytical Development, Bristol Myers Squibb Co.

KEYNOTE PRESENTATION: CMC Challenges with CAR T Manufacturing: Reimagining Process and Product Control Strategy
Sunitha Lakshminarayanan, Head & Executive Director, Cell Therapy Global Process Engineering, Bristol Myers Squibb Co.

HCP Analysis by LC-MS and ELISA in Process Development
Roger Liu, PhD, Scientist, Bristol Myers Squibb Co.

Enhancing Host-Cell Protein Detection in Protein Therapeutics Using HILIC Enrichment and Proteomic Analysis
Qingyi Wang, PhD, Scientist, Bristol Myers Squibb Co.

Quantitative Determination of Titer in Harvest for Bioprocess Using Real-Time FTIR Monitoring
Yuxiang Zhao, PhD, Scientist, Bristol Myers Squibb Co.


Opportunities of Hybrid Model-Based Reinforcement Learning for Cell Therapy Manufacturing Process Control
Zheng Li, PhD, Senior Manager, Manufacturing Science and Technology, Genentech

Early Downstream of a Multi-Armed Bispecific
Ambrose J. Williams, PhD, Scientist, Tech Development, Genentech, Inc.

Optimizing Purifications of Challenging Drug Targets
Maria Lorenzo, Principal Scientific Researcher, Protein Chemistry, Genentech, Inc.

Versatile LC–MS-Based Workflow with Robust 0.1 ppm Sensitivity for Identifying Residual HCPs in Biotherapeutic Products
Feng Yang, PhD, Principal Scientist & MS Core Group Leader, Protein Analytical Chemistry, Genentech, a member of Roche Group


Digital Twin: A Downstream Bioprocess Application
Antonio G. Cardillo, Senior Scientist, GSK Vaccines
Loredana Vagaggini, Tech Senior Product Owner, GSK

Implementation of a Fully Automated Walk-Up Residual DNA qPCR Workflow
Michele Shannon, Investigator, GlaxoSmithKline


Multi-Attribute Monitoring for Process Characterization and Commercial Release
Adam Evans, PhD, Principal Scientist, Analytical Development, Janssen Research and Development

Autonomous Pipeline for Characterization of Biotherapeutics: Integrating Rapid Analytics with Rapid Informatics
Harsha Gunawardena, PhD, Senior Scientist, Mass Spectrometry, Janssen Pharmaceutical Companies of Johnson & Johnson

Challenges and Opportunities in Cell Therapy Drug Product Development
Bharathi Vellalore, PhD, Scientist, Biotherapeutics Drug Product Development, Janssen

Johnson & Johnson

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


Applying Capacitance as a Process Analytical Technology to Vaccine Production: Exploring Process Automation and Enriching Process Understanding
Thomas Randolph Blanda, Associate Scientist, Vaccine Process Development, Merck & Co., Inc.

FEATURED PRESENTATION: Disruptive Technologies for Formulation, Manufacturing, and Delivery: Enabling Advancements for Biologics and Vaccines Products into the Future
Jeff Blue, Executive Director, Vaccine Drug Product Development, Merck & Co., Inc.

Control of High-Risk HCP and Their Impact on PS Degradation
Alex Dow, PhD, Associate Principal Scientist, Merck & Co., Inc.

Transitioning from Batch to Continuous Manufacturing: Comparability of Unit Operations Performance
Parinaz Emami, PhD, Senior Scientist, Downstream Process Development, Merck Research Laboratories

Multiplexing Antibody Potency Assays by Converting Nanoparticles
Jin-Hee Han, PhD, Associate Principal Scientist, Merck & Co., Inc.

Evaluation of a Continuous Live Virus Vaccine Platform: Can It Be Done and What Would the System Look Like?
David Hesley, Scientist, Vaccine Process Research & Development, Merck & Co.

High-Throughput Viral Infection Imaging Methods for Enhancing the Speed of Vaccine Development
Carl Hofmann, Senior Scientist, Analytical Research and Development, Merck & Co.

Lessons Learned from Rapid Process Development of a VSV-SARS-CoV-2 Vaccine Candidate
Laura Kuczynski, Senior Scientist, Vaccine Process Development, Merck & Co.

Identification of Active Enzymes for Polysorbate Degradation in Biotherapeutics by Activity-Based Protein Profiling
Shawn Li, PhD, Principal Scientist, Analytical Research and Development (AR&D) Mass Spectrometry, Merck & Co., Inc.

Increasing Viral Titer through Media Development and Microcarrier Intensification
Jessica Okonkowski, Senior Scientist, Merck & Co.

Impact of Four Inorganic Impurities on the Quality Attributes of a Fc-Fusion Protein
Alessandra Pistacchio, PhD, Biotech Pharmaceutical Development, Drug Product Development, Merck KgaA

Identification and Rapid Characterization of Impurities Resulting in PS-80 Degradation by Proteomics and Charge-Reduced Mass Spectrometry
Shannon Rivera, PhD, Senior Scientist, Merck

High-Throughput Definition and Characterization of a Cell-Based Assays for mRNA-LNP Vaccine Potency
Christina Schier, PhD, Senior Scientist, Merck

Predicting Antibody Developability Profiles through Early-Stage Discovery Screening
Yao Yu, Senior Scientist, Protein Sciences, Merck Research Laboratories

Development of Robust and QC Friendly Compact Mass Spectrometer-Based Peptide Mapping Platform for Biologics Process Control
Chengdong (Jason) Xu, PhD, Senior Scientist, Merck, PhD, Senior Scientist, Merck


Data Science and Digital Technologies in Biopharmaceutical Manufacturing: From Data Sourcing to Model Deployment
Francisca F. Gouveia, PhD, Innovation Data & Digital Lead, MS&T, Novartis Pharma SAS


Assessment of Structural Integrity of Biotherapeutics through Simulated Subcutaneous Environment Using SCISSOR
Deep Bhattacharya, PhD, Senior Scientist, Formulation & Process Development Biotherapeutics, Pfizer Inc.

High-Throughput Solutions for an Intensified Continuous Process
Jenn Pulkowski, Scientist, Pfizer

KEYNOTE PRESENTATION: What Is in Those Capsids? AAV Capsid Content Is an Attribute with Many Measures
Herbert A. Runnels, PhD, Global CMC AAV Analytical Sponsor, Gene Therapy, Pfizer Inc.

Systems Approach to Identify Key Regulations and Bottlenecks in N-Glycosylation Pathway of CHO Cells Used for Therapeutic Protein Production
Madhuresh Sumit, PhD, Principal Scientist, Pfizer Inc.

Lessons Learned from the Pandemic: mRNA-LNP Vaccine Development
Nicholas Warne, PhD, Vice President, Pharmaceutical Research and Development, BioTherapeutics Pharmaceutical Sciences, Pfizer Inc.


KEYNOTE PRESENTATION: High-Risk Host Cell Proteins: A Multi‐Company Collaborative View
Nisha Palackal, PhD, Director, Protein Biochemistry, Regeneron Pharmaceuticals, Inc.


Towards Monitoring and Investigating Cell Culture Process Parameters and Glycosylation Using Digital Twin Modeling
Woo Ahn, PhD, Principal Scientist, Upstream, Global MSAT, DS, Sanofi

Formulation Considerations and Challenges for Non-Viral Gene Delivery
Amey Bandekar, PhD, Associate Director, Drug Product Development, Sanofi

Optimization and Lessons Learned for HCP ELISA Coverage Using Affinity Extraction, Mass Spectrometry, and 2D-PAGE
Michelle Busch, Scientist, Bioanalytics Characterization, Sanofi

CMC Strategies for Process Intensification and Acceleration of IND Submission for Gene Therapies
Srinivas Chollangi, PhD, Director, Cell and Gene Therapy CMC, Sanofi

Quality by Design for ATMPs
Cheryl Essex, Head of Quality Operations R&D Genomic Medicines, Sanofi

N-1 Perfusion at Ambr250 Scale
Jared Franklin, Principal Research Associate, Medium & Bioprocess Technologies, Sanofi US

Process Analytical Technologies – Advances in Bioprocess Integration to Transition to Digital Manufacturing
Marina Kirkitadze, PhD, Head Bioprocess Support & PAT Platform, Analytical Sciences, Sanofi Pasteur

Mechanistic Modeling of a Hydrophobic Interaction Chromatography (HIC) for Protein Antigen Purification
Angela Li, PhD, Senior Scientist, Sanofi Pasteur

Building Reliable Toolboxes and Platforms to Accelerate AAV Purification Process Development
Junfen Ma, PhD, Head, Genomic Medicine Purification Process Development, Sanofi Group

Drug Product Development of an Allogeneic NK-Cell Therapy
Randall Mauldin, PhD, Associate Director, Cell Therapy Drug Product, Sanofi

KEYNOTE PRESENTATION: A Platform Approach for the Rapid Purification of Multi-Specific Antibodies
David J. Reczek, PhD, Head of US Operations, Large Molecule Research, Sanofi

Development of Stable Cell Lines for AAV Production – From Transient Expression to PCL Generation
Saurabh Sen, PhD, Associate Director, Cell Line Development, Genomic Medicine Unit CMC, Sanofi

Navigating International Requirements for Analytical Testing Strategies
Elena A. Smith, PhD, Deputy Director and Quality Analytical Expert, Quality, Sanofi

Sedimentation Velocity Analytical Ultracentrifugation (SV-AUC) as an Important Orthogonal Tool for Gene Therapy Characterization
Ronald T. Toth, PhD, Senior Scientist, Characterization, Sanofi

Formulation and Delivery of Biologics and New Modalities
Anvay Ukidve, PhD, Scientist, Formulation and Process Development, Sanofi


FEATURED PRESENTATION: Production of AAV Vectors: Process Optimization towards Commercialization
Barbara Kraus, PhD, Head, Gene Therapy Process Development, Takeda

FEATURED PRESENTATION: Lab of the Future: Industry 5.0 Strategies and Use-Case Delivery in Pharmaceutical Development
Christoph Pistek, PhD, Head of Technology Sciences, R&D, Pharmaceutical Sciences, Takeda

Modeling & Simulation as One Key Element of Next-Generation CMC
Johannes Scheiblauer, Fellow, Automation & Control, Innovation & Technology Sciences, Pharmaceutical Sciences, R&D, Takeda