Key Sessions

Nathan Lewis, PhD

KEYNOTE: Engineering Out Metabolic Barriers in CHO Cells

University of California, San Diego

Nuno Fontes

Advances in process and manufacturing technology platforms for the industrialization of allogeneic cell therapy

Bayer U.S. LLC

Tiago Matos

Digital Transformation: Accelerating Process Development and Enhancing Control Strategies

Merck

Jacqualyn Schulman, Ph.D.

Engineering CHO Cells to improve a post-translational modification for a bispecific antibody production

Bristol-Myers Squibb

Main Conference Day 1 (Exhibit Hall Open 3:00-6:30pm)Tuesday, 12 March 2024 - PT (Pacific Time, GMT-08:00)

7:00am - 8:00am

Coffee and Registration

Showing 1 of 1 Streams

Plenary Keynote Sessions

8:00am - 8:10am

Chairperson's Opening Remarks

Dhanuka Wasalathanthri, PhD - Associate Director, Bristol Myers Squibb

8:10am - 8:50am

Advances in process and manufacturing technology platforms for the industrialization of allogeneic cell therapy

Nuno Fontes - Head of Global Biologics Development (GBD), Bayer U.S. LLC

8:50am - 9:30am

Digital Transformation: Accelerating Process Development and Enhancing Control Strategies

Tiago Matos - Associate Principal Scientist, Merck

9:30am - 10:25am

Morning Break

Showing 6 of 6 Streams

Cell Line Development & Engineering

Cell Culture & Upstream Processing

Recovery & Purification

Manufacturing Strategy & Bioprocessing 4.0

Cell and Gene Therapy Manufacturing

10:25am - 10:30am

Chairperson's Remarks

Yashas Rajendra Ph.D. - Associate Director & Principal Scientist, Denali Therapeutics

10:30am - 11:00am

The impact of expression vector position on transgene transcription allows for rational expression vector design in a targeted integration system

Kathryn Beal - Principal Scientist: Process Development, Pfizer, Inc.

11:00am - 11:30am

An Evaluation of Simultaneous Proline Selection in CHO Cells

Hooman Hefzi - Senior Scientist, Biogen

11:30am - 12:00pm

When will we have a clone? An industry perspective on the typical CLD timeline

Stephanie Rieder - Principal Research Scientist, Process Sciences, CHO Cell Line Development, AbbVie, Inc.
Ren Liu - Senior Principal Scientist, Merck

10:25am - 10:30am

Chairperson's Remarks

Atul Joshi - Principal Scientist, Upstream Process Development, KBI Biopharma

10:30am - 11:00am

Cell Culture Digital Twins Enabling Efficient Scale Up and Tech Transfer

Brooke Tam - Process Engineer IV, Sanofi

11:00am - 11:30am

Transfer Learning and Real-time Architectures of Digital Twins

Christoph Herwig - Fr. Professor for Biochemical Engineering Senior Scientific Advisor, Körber Pharma Austria GmbH

11:30am - 12:00pm

Overcoming Raw Material Variability in Bioprocessing

Meike Roskamp - Head of Business Management, Biopharma Ingredients, Formerly R&D Lab Leader, BASF

10:25am - 10:30am

Chairperson's Remarks

Ruben Carbonell - Director, William R. Kenan, Jr. Institute for Engineering, Technology & Science, Frank Hawkins Kenan Distinguished Professor of Chemical and Biomolecular Engineering, North Carolina State University

10:30am - 11:00am

Keynote Address: Fully Continuous purification platform using nanoparticles with ligands and ultrafiltration

Irina Ramos - Director, Bioprocess Technology and Engineering, AstraZeneca

11:00am - 11:30am

A Review of Supports for Adsorptive Separations of Biomolecules

Tom Ransohoff - Principal, RTI Consulting, LLC

11:30am - 12:00pm

Designing Purification Strategies for Bispecific Antibodies

Alexandra Cabatingan - Bioprocess Resin Sales Specialist, Cytiva

10:25am - 10:55am

Please Move To Another Track

10:55am - 11:00am

Chairperson's Remarks

Alanna Benamy - Manager, Member Engagement, Rx-360

11:00am - 11:30am

Plastics: A Biophorum Case Study

Merete Miles - Sr. Director Environmental Sustainability, Thermo Fisher Scientific

11:30am - 12:00pm

Sustainability in Bioprocessing: A Pathway towards a Greener Future

Adam Goldstein - Senior Director, R+D Collaborations, Thermo Fisher Scientific

10:25am - 10:30am

Chairperson's Remarks

10:30am - 11:00am

Enhancing rAAV Manufacturing: The Role of Plasmid Design and Material Characteristics

Soundarya Kandala - Senior Associate Scientist, Biogen

11:00am - 11:30am

An Automated and Data-Driven Future of Robust Producer Cell Line Development Platform for AAV Gene Therapy

Saurabh Sen - Associate Director, Cell Line Development, Genomic Medicine Unit CMC, Sanofi

11:30am - 12:00pm

Fast, scalable and reliable AAV empty/full ratios with mass photometry

Amy Chau - Senior Field Applications Scientist, Refeyn

10:25am - 10:30am

Chairperson's Remarks

10:30am - 11:00am

Harnessing the power of Gamma Delta CAR-T Cells for enhanced treatment durability

Kate Rochlin - Chief Operating Officer, IN8bio, USA

11:00am - 11:30am

Preclinical Development of LYL119, a ROR1-Targeted CAR T-cell Product Incorporating Four Novel T-Cell Reprogramming Technologies to Overcome Barriers to Effective Cell Therapy for Solid

Bijan Boldajipour - Vice President Discovery and Development, Lyell Immunopharma, Inc., USA

11:30am - 12:00pm

Reducing Risk in the Biomanufacturing cold chain: The Durable Primary Packaging Solution

Joe Cintavey - Product Manager, W.L. Gore & Associates, Inc.

12:00pm - 12:10pm

Transition to Lunch Presentations

Showing 3 of 3 Streams

Sponsored Luncheon Presentation

12:10pm - 12:55pm

Increasing the productivity of antibody capture with a scalable Protein A membrane chromatography consumable

James Sulzberger - Chromatography Consumables Product Specialist, Sartorius Stedim Biotech

12:10pm - 12:55pm

Top digital considerations to prepare your process development organization for the surge in new modalities, and AI/ML

Michael Schwartz - Product Specialist, Development, Benchling
Justin De La Cruz - Solutions Consultant, Benchling

12:10pm - 12:55pm

Environmental Sustainability at Novartis

Lee Willmon - HSE Regional Business Partner, Americas, Novartis

12:55pm - 1:25pm

Lunch

Showing 6 of 6 Streams

Cell Line Development & Engineering

Cell Culture & Upstream Processing

Recovery & Purification

Manufacturing Strategy & Bioprocessing 4.0

Cell and Gene Therapy Manufacturing

1:25pm - 1:30pm

Chairperson's Remarks

Hooman Hefzi - Senior Scientist, Biogen

1:30pm - 2:00pm

KEYNOTE: Engineering Out Metabolic Barriers in CHO Cells

Nathan Lewis, PhD - Professor, University of California, San Diego

2:00pm - 2:30pm

Engineering CHO Cells to improve a post-translational modification for a bispecific antibody production

Jacqualyn Schulman, Ph.D. - Senior Scientist, Cell Line Development & ‘Omics Biologics Development, Bristol-Myers Squibb

2:30pm - 3:00pm

Using MicroFluidics to Accelerate Analytical Testing in AAV Process Development and Manufacturing

Maria Germana Sanna, Ph.D. - Field Application Scientist, Gyros Protein Technologies

1:25pm - 1:30pm

Chairperson's Remarks

Atul Joshi - Principal Scientist, Upstream Process Development, KBI Biopharma

1:30pm - 2:00pm

Improving titers in an intensified cell culture process using machine-learning assisted clone selection

Brandon Downey - Principal Engineer, R&D, Lonza

2:00pm - 2:30pm

Achieving Product Quality Targets While Maintaining High Titer in CHO Cell Culture Processes

Ryan Graham - Technical Development Principal Scientist, Genentech, Inc.

2:30pm - 3:00pm

Perfecting Perfusion Performance: CHOZN® GS-/- Cell Line Development for Intensified Processes

Vince Balassi - Scientist III, Upstream and Process Materials R&D, Milliporesigma

1:25pm - 1:30pm

Chairperson's Remarks

Tom Ransohoff - Principal, RTI Consulting, LLC

1:30pm - 2:00pm

Depth Filtration for the Removal of Host Cell Proteins

Liang-Kai Chu - Ph.D. Candidate, Pennsylvania State University

2:00pm - 2:30pm

Use of Nonwoven Membranes for Process Chromatography

Ruben Carbonell - Director, William R. Kenan, Jr. Institute for Engineering, Technology & Science, Frank Hawkins Kenan Distinguished Professor of Chemical and Biomolecular Engineering, North Carolina State University

2:30pm - 3:00pm

An innovative approach to address high aggregate challenges in engineered monoclonal antibodies using flow through chromatography

Al de Leon - Manager, Thermo Fisher Scientific

1:55pm - 2:00pm

Chairperson's Remarks

John Schiel, Ph.D. - Research Chemist, IBBR, National Institute of Standards and Technology

2:00pm - 2:30pm

Building a Framework for Technology Transfer for Late-Phase and Commercial Production

Shawn Allwein - Vice President, Biologics CMC, Teva

2:30pm - 3:00pm

Chromatography modeling trends – the future of process development

Jennifer Reichert - Account Development Manager, Cytiva

1:25pm - 1:30pm

Chairperson's Remarks

1:30pm - 2:00pm

Case Studies to ponder for manufacturing mRNA therapeutics

Padmadhar Madupu, MS - Director, Manufacturing, Omega Therapeutics

2:00pm - 2:30pm

Increasing Efficiencies in Upstream Process Development for Gene Therapies

Dan Comiskey - Scientist II, Early Process Development (Upstream), Sarepta Therapeutics

2:30pm - 3:00pm

Not Created Equal: Impact of Deamidation on Capsid Heterogeneity and Anion Exchange Chromatography (AEX) Performance

Alex Meola - Associate Director, Purification Sciences, Oxford Biomedica (US) LLC

1:25pm - 1:55pm

Lunch

1:55pm - 2:00pm

Chairperson's Remarks

2:00pm - 2:30pm

Developing novel macrophage based cell therapies: CARs and beyond

Sherly Mardiana, PhD - Principal Scientist, Research/Discovery, Carisma Therapeutics

2:30pm - 3:00pm

Advancing Manufacturing: A Robust Approach to Integrated Circuit T Cell (ICT) Production through Targeted CRISPR Integration and Electroporation (CITE) Editing

Swetha Gunturu - Senior Scientist, ArsenalBio

3:00pm - 4:00pm

Afternoon Break in Exhibition Hall

Showing 6 of 6 Streams

Cell Line Development & Engineering

Cell Culture & Upstream Processing

Recovery & Purification

Manufacturing Strategy & Bioprocessing 4.0

Cell and Gene Therapy Manufacturing

4:00pm - 4:30pm

Generation of Fucosyltransferase 8 Knock-out CHO-K1 host cell lines

Tiffany McLamarrah - Senior Scientist, Sanofi

4:30pm - 5:00pm

CHO cell-based targeted integration platform for accelerated antibody development

Yuansheng Yang - Senior Principal Scientist, A*STAR

4:00pm - 4:30pm

Overcoming Challenges During Process Scale Up from 2kL to 12kL

Robin Luo - Associate Director, Boehringer Ingelheim

4:30pm - 5:00pm

Into the unknown: Planning and managing beyond the mAb

Sheldon Oppenheim - Engineering Fellow, Takeda Pharmaceuticals

4:00pm - 4:30pm

From a bench-scale rAAV platform process to GMP manufacturing: a look at how Tangential Flow Filtration (TFF) robustness and scaling impact successful process transfer

Tyler Kennedy - Scientist, Gene Delivery Process and Analytical Development, Bristol Myers Squibb

4:30pm - 5:00pm

Assessing the Impact of Cumulative Hold during Purification on the Stability of Recombinant Adeno-associate Viral Product

Wenjun Di - Senior Scientist, Ultragenyx Pharmaceutical Inc.

4:00pm - 4:30pm

Best Practices in Implementing a Supplier Assessment Questionnaire

Alanna Benamy - Manager, Member Engagement, Rx-360

4:30pm - 5:00pm

Big Ideas, Bold Goals, and the Future of Biomanufacturing

John Schiel, Ph.D. - Research Chemist, IBBR, National Institute of Standards and Technology

4:00pm - 4:30pm

From a bench-scale rAAV platform process to GMP manufacturing: a look at how Tangential Flow Filtration (TFF) robustness and scaling impact successful process transfer

Tyler Kennedy - Scientist, Gene Delivery Process and Analytical Development, Bristol Myers Squibb

4:30pm - 5:00pm

Assessing the Impact of Cumulative Hold during Purification on the Stability of Recombinant Adeno-associate Viral Product

Wenjun Di - Senior Scientist, Ultragenyx Pharmaceutical Inc.

5:00pm - 6:30pm

Cocktail Reception in Exhibit & Poster Hall

Main Conference Day 1 (Exhibit Hall Open 3:00-6:30pm)Tuesday, 12 March 2024 - PT (Pacific Time, GMT-08:00)

Main Conference Day 1 (Exhibit Hall Open 3:00-6:30pm)Tuesday, 12 March 2024 - PT (Pacific Time, GMT-08:00)

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