Over 75 Presentations from Top Pharma Companies at the Bioprocessing Summit
Immerse yourself in presentations delivered by industry visionaries, thought leaders, and pioneers, offering unique perspectives that inspire progress and drive innovation.
CMC Development Digital Continuum
Dana I. Filoti, PhD, Associate Director of Scientific Architecture, Development Sciences Data and Digital Strategy, AbbVie
Transforming Downstream Processes: From Paper to Digital with an In-House LIMS
Brian R. Lowry, PhD, Principal Research Scientist II, Purification, AbbVie
Michail Vlysidis, PhD, Principal Engineer, AbbVie
Enhancing Aggregate Reduction Using Anion Exchange Hybrid Filter in an Immunocytokine Diabody Fusion Protein Purification Process
Jian Ren, PhD, Principal Scientist, AbbVie
Challenges and Process Development for Purification of Gene Therapy Vector AAV
Xue Mi, PhD, Senior Scientist I, Purification Process Development, AbbVie Bioresearch Center
Insight into the Degradation Pathways of an AAV9
Chen Zhou, PhD, Principal Research Scientist, Biologics Drug Product Development, AbbVie Bioresearch Center
Investigation of Bak/Bax Double Knockouts in a GSKO CHO System
Geneva Alok, PhD, Process Development Scientist, Amgen
The Bumpy Road to Implementation: Why There Isn't More AI in Manufacturing, and How to Reroute the Course
Myra Coufal, PhD, Director, Process Development, Amgen Inc.
Lessons Learned: Adapting Existing Processes to Established Cell-Culture Platforms
Paul Gramlich, PhD, Director, Process Development, Amgen Inc.
Automated End-to-End Data Paradigm for Biologics Bioprocess Development
Yi Li, PhD, Principal Scientist, Process Development, Amgen Inc.
Evaluating Parameters Influencing Recovery and Stability of Low-Dose In-Use Formulations
Zahra Ghassemi, PhD, Senior Scientist, Dosage Form Design & Development, AstraZeneca
Best Practices for Bioanalysis of ADCs
John "Jack" Kellie, PhD, Group Director, Integrated Bioanalysis, AstraZeneca
Visible Particles within Cell Therapies
Swapnil K Pansare, Director, MSA&T, AstraZeneca
Enhancing Biologics Manufacturing Efficiency through Data Science: Insights from Case Studies
Shyam Panjwani, PhD, Principal Data Scientist, Bayer Healthcare Pharmaceuticals
Next-Generation Sequencing (NGS) for Extended Characterization of Cell Therapies: Enhancing Product and Process Characterization
Wenjie Yao, PhD, Staff Scientist, Cell Therapy Analytical Development, Bayer US LLC
SoloVPE as a Substitute for LC-UV for at-Line Determination of Oligonucleotide Crude Concentration
Tai Nguyen, Scientist, Biogen
Preparation of Anti-Sense Oligonucleotide (ASO) via Hybrid Synthesis
Jiabao Zhang, PhD, Scientist I, Biogen
Enhancing the Sustainability of Drug Substance Processes through Process Evolution and Facility Fit Modeling
Christopher Furcht, PhD, Director, Biologics Development, Bristol Myers Squibb
KEYNOTE PRESENTATION: Aligned Control Strategy Proportions and Staging Opportunities—Concept and Execution Roadmap for an Enhanced and Integrated Analytical Control Strategy
Stephan O. Krause, PhD, Executive Director Analytical Quality, BMS Cell Therapies
End-to-End Automated HTP Platform for Biotherapeutics Discovery
Whitney Liu, PhD, Principal Scientist, Bristol Myers Squibb Co.
Co-Formulation of Antibodies and Peptides: Challenges and Strategies
Steven Cottle, Senior Advisor, Biotherapeutic Discovery and Research, Eli Lilly & Company
Development of a Universal and Scalable Adeno-Associated Virus Capture Step Using Steric Exclusion Chromatography
Juan Carlos Rosario, PhD, Senior Principal Scientist, Purification & Virology Development, Eli Lilly & Company
Novel High-Throughput Multiplex MSD Method for Characterizing rAAV Genome Integrity
Xushan Wang, Director, Eli Lilly & Company
Single-Use Facility Strategy: The Need for Advanced Single-Use Bioreactors and Universal Controllers
Edward Chan, Senior Technical Specialist, Cell Culture and Bioprocess Operations, Genentech Inc.
CHO Host Glycosylation Engineering
SeongCho Dong, PhD, Technical Development Associate Scientist, Genentech Inc.
Reduce Energy Usage for Drug Substance Facilities: Development and Application of Models
Ken Hamilton, Distinguished Engineer, Genentech
Utilization of Activated Carbon for FDRI Removal in ADCs
Brandon Coyle, PhD, Senior Research Scientist II, Gilead Sciences Inc.
Understanding Product Attribute Shifts in Large-Scale Manufacturing: A Case Study
Gisel Lopez, Senior Research Associate I, Upstream Process Development, Gilead Sciences Inc.
Hybrid Modeling Approaches for Biopharmaceutical Drug Substance Development
Samira Beyramysoltan, PhD, Senior Scientist, Modeling and Simulation, GSK
Identification of Dominant Factors Leading to High Viscosity in Antibodies by Application of Automated DoE Excipient Screening
Alejandro D'Aquino, PhD, Principal Investigator, GSK
Advancements in Automated Biologics Formulation Screening to Meet a Dynamic Pipeline
Alex Vouga, PhD, Automation Investigator, Drug Product Development, GSK
Building the Lab of the Future for Protein Production in the Age of AI and Automation
Iman Farasat, PhD, Director, High Throughput Expression, Johnson & Johnson Innovative Medicine
Proteomic Approaches to Cell-Line Engineering
Gihoon Lee, PhD, Senior Scientist, Johnson & Johnson Innovative Medicine
KEYNOTE PRESENTATION: Considerations for Process Development (CAR T Drug Product and Lentiviral Vector) in Autologous Cell Therapy for Commercial Manufacturing
Ravi Bhatia, Scientific Director, Cell Technology, Johnson & Johnson Pharmaceutical R&D
Turning Diverse Analytical Data into Actionable Knowledge for Enzymatically Driven Polysorbate Degradation Risk Assessment and Control in Biotherapeutic Protein Formulations
Alex Dow, PhD, Associate Principal Scientist, Merck & Co., Inc.
KEYNOTE PRESENTATION: Platform Fit for Non-Platform Molecules
Shuangping Shi, Associate Vice President, Head of Biologics Process Research & Development, Merck & Co.
Integrating LC-MS-Based Metabolomics and Machine Learning for Enhanced Insights into Bioprocesses
Yudong Sun, PhD, Postdoc Researcher, Merck
Navigating Platform Constraints during Rapid Scale-Up Process Transfer for Yeast Fermentation Clinical Drug Substance Manufacture
Griffin Thomas, Senior Scientist, Preclinical Development, Vaccines and Advanced Biotechnologies Process R&D, Merck & Co., Inc.
Enhancing Analytical and QC Testing for Biologics Using Modular Automation System and Semi-Automation Approach
Meng Xu, PhD, Senior Scientist, Lab Automation, Merck
Site-Specific Integration to Streamline Cell-Line Development and Speed to Clinic
Shengyuan Zhao, PhD, Senior Scientist, Process Cell Sciences, BPR&D, Merck & Co.
The Behavior of Modified AAV Capsids in CE-Based Techniques
Chelsey Mattison, Scientist, Novartis
Accelerating Analytical Development: Implementing Platform Approaches and Embracing Smart Risks
Tilen Praper, PhD, Associate Director, Process Analytical Science, Novartis Pharmaceuticals
Using Immunoprecipitation and Mass-Spectrometry to Analyze Cell-Surface Proteins
Nicolle Serrano SantoDomingo, Senior Scientist, Novartis
FEATURED PRESENTATION: Novel Applications of Mass Photometry in Early R&D for Innovative Biotherapeutic Modalities
Fabian Soltermann, PhD, Principal Scientist, Biomedical Research, Novartis
FEATURED PRESENTATION: Novel Lipid Excipient Strategies for mRNA Lipid Nanoparticles
Roger H. Pak, PhD, Research Fellow, BTx Pharm R&D, Pfizer Inc.
Next-Generation Sequencing as a Platform Method for Identity & Multivalent Ratio Release Testing of Nucleic-Acid Products
Carlos Castaneda, Principal Scientist, Pfizer Inc.
CHO Site-Specific Integration System Enables Development of Stable Pools with Comparable Attributes to Clonal Cell Lines
Mam Mboge, PhD, Senior Scientist, Molecular & Cellular Technologies, Biotherapeutics Pharmaceutical Sciences, Pfizer Inc.
Optimizing Critical Reagents: A Key Strategy when Accelerating Analytical Development of Potency Release Assays
Byung Chul Kim, PhD, Principal Scientist, Protein Biochemistry, Regeneron Pharmaceuticals
Development and Qualification of AAV Stability Indicating Methods
Wen Shi, PhD, Regeneron
Automated High-Throughput Method for the Quantitation of Glucose Tetrasaccharide in Human Plasma
Avraham Rosenberg, MS, Senior Scientist, Analytical Chemistry, Regeneron
From Data to Decisions: Transforming Upstream Processes with Digital Tools
Taha Salim, PhD, Staff Engineer, Regeneron Pharmaceuticals Inc.
Identification and Quantification of Phosphorothioate Stereoisomers in sgRNA Using LC Ion-Mobility Mass Spectrometry
Yue Su, Scientist, Regeneron
Unveiling AAV Adsorption at Interfaces across Drug-Development Stages Using QCMD
Yasmin Van Cura, Senior Associate Scientist, Formulation Development, Regeneron Pharmaceuticals
Formulation and Stability
Jonathan Wert, Senior Scientist, Formulation Development, Regeneron Pharmaceuticals Inc.
Exploring Molecular Mechanisms of AAV Production Using RNA Sequencing
Zhe Zhang, PhD, Senior Staff Engineer, PMPD VPC, Regeneron Pharmaceuticals Inc.
MS for the Characterization of Glycoproteins
Yunlong Zhao, PhD, Principal Scientist, Analytical Chemistry, Regeneron Pharmaceuticals
Development of End-to-End Digital Twins for Continuous Bioprocessing
Gabriele Bano, PhD, Head of Process Modeling, Global CMC Development - Data Sciences, Sanofi
Advances in Lipid Nanoparticles Analytics
Wei-Chiang Chen, PhD, Associate Director, BioProcess Analytics, Genomic Medicine Unit, Sanofi
Optimal Control of a Continuous Ultrafiltration/Diafiltration Process for mAb Manufacturing
Anastasia Nikolakopoulou, PhD, Senior Data Scientist, Process Simulation and Control, Sanofi
KEYNOTE PRESENTATION: Formulation & Process Development Considerations for Nonviral Gene Delivery
Amey Bandekar, PhD, Associate Director, Drug Product Development, Sanofi
Drug Product Development Strategies for AAV Gene Therapies
Tuna Yucel, PhD, Senior Scientist, Biologics Drug Product Development & Manufacturing, Sanofi
Advanced Upstream rAAV Process for Scalable Gene Therapy Applications
Nipun Goel, Senior Scientist, Sanofi
Application of Digital Tools to LNP Formulation and Process Development
Umang Khamar, Scientist, Sanofi
Optimizing Producer Cell Line Performance through High-Throughput Screening Techniques
Amit Mathur, PhD, Senior Scientist, Genomic Medicine Unit, Sanofi
New Methods to Develop Binding ELISAs for Multispecifics
Theresa O'Brien, Scientist, Sanofi
Small-Scale Model Development for Ultrafiltration/Diafiltration (UF/DF): Detecting, Understanding, and Accounting for Differences Between the Bench and the Manufacturing Facility
Krishn Patel, Sr Research Assoc, Purification Dev, Sanofi
From Seed to Drug Substance: Acceleration of Manufacturing Process to One Week
Jennifer Reid, PhD, Senior Scientist, Vaccine Drug Substance Development, Sanofi
Early LNP Development Considerations and Challenges
Yuefei Shen, PhD, Principal Scientist, CMC Drug Product Development, Sanofi
Product-Specific Host-Cell ELISA Assays
Jonathan Sun, Scientist, Assay Development, Sanofi
Drug Product Development Strategies for AAV Gene Therapies
Tuna Yucel, PhD, Senior Scientist, Biologics Drug Product Development & Manufacturing, Sanofi
Advancing Platform Processes through Intensified Operations and PAT
Terrence Dobrowsky, PhD, Head, Technology Development and Implementation, Takeda Development Center Americas, Inc.
A Digital-First Approach to Downstream Bioprocessing
Laura Pereira-Diaz, PhD, Digital CMC Scientist, Takeda
Using NGS to Facilitate Cell Line Development
Ying Shen, PhD, Assoc Scientific Fellow, Takeda Pharmaceuticals
AI-Driven Advances in Upstream Cell Culture Optimization: Challenges and Opportunities
Rui Sun, Digital Scientist, Takeda Pharmaceuticals Inc.
Site-Specific Polyclonal Antibody Immobilization as a Platform for Targeted Capture and Deep Characterization of Complex Host Cell Proteins
Leo Wang, PhD, Senior Scientist, Takeda
Transfer Strategies (Interphase, between Sites, Development to QC/GMP, to/from CDMO)
Xiaoyang Zheng, PhD, Scientific Fellow, Global Manufacturing Science & Global Quality, Takeda