DAY TWO WATCH LIVE (EST): September 22nd

10:00am - 10:05am5 mins

Announcements and Opening Remarks

10:05am - 10:30am25 mins

KEYNOTE ADDRESS: Importance of Data Integrity in Non-GMP Studies

Nadine Ritter, Ph.D. - President and Analytical Advisor, Global Biotech Experts, LLC

10:30am - 10:40am10 mins

Live Q&A with Nadine Ritter

Nadine Ritter, Ph.D. - President and Analytical Advisor, Global Biotech Experts, LLC

10:40am - 11:20am40 mins

Networking Forum and Exhibitor “Meet and Greet”

11:20am - 11:40am20 mins

Cell Line Development & Engineering

Cell Line Development with High Titer and Long Term Stability

Sung Ho Hahm - CEO, Rophibio Inc.

11:20am - 11:40am20 mins

Cell Culture & Upstream Processing

Overcoming the Challenges of Implementing Continuous Processing

Daryl Powers, PhD - Head US Upstream Cell Culture Development, Sanofi

11:20am - 11:40am20 mins

Recovery & Purification

Understanding and Mitigation of Polysorbate Hydrolysis by CHO Enzymes

Troii Hall, M.S. - Associate Consultant Chemist, Bioprocess Research & Development, Eli Lilly and Company

11:20am - 11:40am20 mins

Intensified and Continuous Processing

Overcoming the Challenges of Implementing Continuous Processing

Daryl Powers, PhD - Head US Upstream Cell Culture Development, Sanofi

11:20am - 11:40am20 mins

Speed from Gene to Market

Utilizing Prior Knowledge Assessments of Process Characterization Cell Culture and Purification Operations to Accelerate FMEA Risk Assessments During Process Design

Coral Fung Shek - Process Development Associate Scientist, Amgen

11:20am - 11:40am20 mins

Manufacturing Strategy & Bioprocessing 4.0

Case Study: Best Practises for Streamlining Technology Transfer Processes

Jonathan Tsang - Director, Manufacturing Sciences & Technology Biotech, Technology Transfer, Bayer

11:40am - 12:00pm20 mins

Cell Line Development & Engineering

Evaluating New CHO Hosts for a New Therapeutic Platform – What Caused Radically Different Expression and Product Quality Levels?

Susan Dana Jones, Ph.D. - SVP, Product Development, Harpoon Therapeutics Inc.

11:40am - 12:00pm20 mins

Cell Culture & Upstream Processing

Advanced Real-Time Monitoring of Biologics In Continuous Perfusion Bioprocesses Using Raman Spectroscopy

Mengyao Li - Post Doc Next Generation High-Densit,Advanced Process & Manufacturing Technology, Novartis Pharma AG

11:40am - 12:00pm20 mins

Recovery & Purification

Polysorbate Degradation and Particle Formation in Biotherapeutics

Karen Rutherford, PhD - Technical Development Sr. Scientist, Genentech

11:40am - 12:00pm20 mins

Intensified and Continuous Processing

Advanced Real-Time Monitoring of Biologics In Continuous Perfusion Bioprocesses Using Raman Spectroscopy

Mengyao Li - Post Doc Next Generation High-Densit,Advanced Process & Manufacturing Technology, Novartis Pharma AG

11:40am - 12:00pm20 mins

Speed from Gene to Market

Evaluating New CHO Hosts for a New Therapeutic Platform – What Caused Radically Different Expression and Product Quality Levels?

Susan Dana Jones, Ph.D. - SVP, Product Development, Harpoon Therapeutics Inc.

11:40am - 12:00pm20 mins

Manufacturing Strategy & Bioprocessing 4.0

Data Science and Digitalization is the Perceived Enabler for Accelerating Technology Transfer and Process Validation

Christoph Herwig - Bioprocess Engineering Professor, TU Wien, Austria

12:00pm - 12:20pm20 mins

Cell Line Development & Engineering

Building a high confidence image-based clonality workflow. Is 99% clonal assurance good enough?

Mark Stockdale - Amalgamator of Business and Biology, Solentim

12:00pm - 12:30pm30 mins

Cell Culture & Upstream Processing

Live Speakers Discussion Forum

12:00pm - 12:30pm30 mins

Recovery & Purification

Live Speakers Discussion Forum

12:00pm - 12:30pm30 mins

Intensified and Continuous Processing

Live Speakers Discussion Forum

12:00pm - 12:30pm30 mins

Speed from Gene to Market

Live Speakers Discussion Forum

12:00pm - 12:30pm30 mins

Manufacturing Strategy & Bioprocessing 4.0

Live Speakers Discussion Forum

12:20pm - 12:30pm10 mins

Cell Line Development & Engineering

Live Speakers Discussion Forum

Mark Stockdale - Amalgamator of Business and Biology, Solentim

12:30pm - 12:50pm20 mins

Cell Line Development & Engineering

Live Speakers Discussion Forum

Mark Stockdale - Amalgamator of Business and Biology, Solentim

12:30pm - 12:50pm20 mins

Technology Workshop 1

How to get the most out of your fed-batch process: strategies for production media and feed regime development as well as process intensification

Andreas Castan, PhD - Strategic Technology Partnerships Leader, Cytvia

12:30pm - 12:50pm20 mins

Technology Workshop 2

Ensuring Consistency of Raw Materials & Supply for Proprietary Cell Culture Formulations

Chad Schwartz, PhD - Senior Product Manager, Thermo Fisher Scientific

12:30pm - 12:50pm20 mins

Technology Workshop 3

Novel technology concepts for cost-effective virus production

Tania Pereira Chilima - Deputy Chief Technology Officer, Univercells Technologies

12:30pm - 12:50pm20 mins

Technology Workshop 4

Facility-Fit Driven Development for a MAB Production Process

Haiou (Hio) Yang - Director, Process Development, Avid Bioservices, Inc.

12:30pm - 12:50pm20 mins

Technology Workshop 5

Novel laser-based analyzer for real-time biophysical characterization of biologics

Craig Magee, PhD - Director, Business Development - Life Sciences, DRS Daylight Solutions

12:30pm - 12:50pm20 mins

Technology Workshop 6

Enabling new bioprocess simplification and intensification strategies using advanced process technology solutions.

Alexei Voloshin, PhD - Biopharma Application Engineering Manager, 3M

12:50pm - 1:20pm30 mins

Spotlight Presentation 1

Key challenges and potential solutions for eliminating bottlenecks and optimizing biopharma downstream processes

Christiane Schwittay - Director, Strategic Marketing Biopharma Production, Avantor

12:50pm - 1:20pm30 mins

Spotlight Presentation 2

Using High-Throughput Microbioreactors to Fit Raman Spectroscopy Model for Measuring Key Metabolites in Monoclonal Antibody Cell Culture Manufacturing Process

Dan Kopec - Process Analytical Technolgy Expert, Sartorius Stedim Biotech
Michael Nelson - Senior Scientist, Merck & Co.

1:20pm - 2:00pm40 mins

Live Round Table Discussions

2:00pm - 2:20pm20 mins

Cell Line Development & Engineering

Implementing High-throughput and Automated Clonal Evaluation

Jishna Ganguly - Associate Research Scientist, GSK

2:00pm - 2:20pm20 mins

Cell Culture & Upstream Processing

Process Intensification: Implementation of Continuous Manufacturing in Upstream Processing

Anita Kundu - Senior Associate Scientist, Pfizer

2:00pm - 2:20pm20 mins

Recovery & Purification

Transitioning from Chemistry Based Purification to Protein Based Purification for Antisense Oligonucleotides

Robert Gronke, PhD - Senior Principal Scientist, Technical Development, Biogen, Inc

2:00pm - 2:20pm20 mins

Intensified and Continuous Processing

Process Intensification: Implementation of Continuous Manufacturing in Upstream Processing

Anita Kundu - Senior Associate Scientist, Pfizer

2:00pm - 2:20pm20 mins

Speed from Gene to Market

FEATURED PRESENTATION: Developability to Ensure Streamlined Manufacturing

Jonathan Kingsbury - Head of Developability & Pre-formulation, Sanofi

2:00pm - 2:20pm20 mins

Manufacturing Strategy & Bioprocessing 4.0

Utilising Single Use Technologies in Commercial Manufacturing

Weibing Ding, PhD - Director, GSK

2:20pm - 2:40pm20 mins

Cell Line Development & Engineering

QX ONE Droplet Digital PCR for Cell Line Development

Brandon McKethan, PhD - Field Application Specialist, Bio-Rad Laboratories, Inc.

2:20pm - 2:40pm20 mins

Cell Culture & Upstream Processing

Improving Product Quality Through Cell Culture Process Intensification

Yan Wang - Senior Scientist, Amgen

2:20pm - 2:40pm20 mins

Recovery & Purification

Control Strategy for Beta-Glucan Impurities in Downstream Processes

Mahsa Rohini, Ph.D. - Scientist, Pivotal Drug Substance, Process Development, Amgen

2:20pm - 2:40pm20 mins

Intensified and Continuous Processing

Improving Product Quality Through Cell Culture Process Intensification

Yan Wang - Senior Scientist, Amgen

2:20pm - 2:40pm20 mins

Speed from Gene to Market

Aligning the R&D and Marketing TPP to Achieve R&D and Commercial Success

Regina Au, MBA, MIM - Principal, New Product Planning/Strategic Planning, BioMarketing Insight

2:20pm - 2:40pm20 mins

Manufacturing Strategy & Bioprocessing 4.0

Single-Use Assembly Standardization: innovative approaches to enable standardization

Hana Sheikh - Senior Engineer, Roche-Genentech

2:40pm - 3:20pm40 mins

Cell Line Development & Engineering

Networking Forum and Exhibitor “Meet and Greet”

2:40pm - 3:20pm40 mins

Cell Culture & Upstream Processing

Networking Forum and Exhibitor “Meet and Greet”

2:40pm - 3:20pm40 mins

Recovery & Purification

Networking Forum and Exhibitor “Meet and Greet”

2:40pm - 3:20pm40 mins

Intensified and Continuous Processing

Networking Forum and Exhibitor “Meet and Greet”

2:40pm - 3:20pm40 mins

Speed from Gene to Market

Networking Forum and Exhibitor “Meet and Greet”

2:40pm - 3:20pm40 mins

Manufacturing Strategy & Bioprocessing 4.0

Networking Forum and Exhibitor “Meet and Greet”

3:20pm - 3:40pm20 mins

Cell Line Development & Engineering

Rapid Manufacturing Platform for Biologics

Yves Durocher, PhD - Section Head, Mammalian Cell Expression - NRC Human Health Therapeutics Research Center, National Research Council Canada

3:20pm - 3:40pm20 mins

Cell Culture & Upstream Processing

KEYNOTE ADDRESS: Rapidly Responding to Ebola Using Regeneron Platform Technologies

3:20pm - 3:40pm20 mins

Recovery & Purification

KEYNOTE ADDRESS: Rapidly Responding to Ebola Using Regeneron Platform Technologies

3:20pm - 3:40pm20 mins

Intensified and Continuous Processing

KEYNOTE ADDRESS: Rapidly Responding to Ebola Using Regeneron Platform Technologies

3:20pm - 3:40pm20 mins

Speed from Gene to Market

KEYNOTE ADDRESS: Rapidly Responding to Ebola Using Regeneron Platform Technologies

3:20pm - 3:40pm20 mins

Manufacturing Strategy & Bioprocessing 4.0

KEYNOTE ADDRESS: Rapidly Responding to Ebola Using Regeneron Platform Technologies

3:40pm - 4:00pm20 mins

Cell Line Development & Engineering

Using Octet for High-Throughput Early Clone Selection

Hongshan Li, PhD - Marketing Applications Manager, Sartorius

3:40pm - 4:00pm20 mins

Cell Culture & Upstream Processing

SymphonX™ a Generic Downstream Single-Use Purification Rig for Continuous Bioprocessing

Charles Heise, PhD - Senior Staff Scientist BioProcess Strategy & Development, FUJIFILM Diosynth Biotechnologies

3:40pm - 4:00pm20 mins

Recovery & Purification

Development of a second generation PlasmidSelect resin

Tony Hitchcock - Technical Director, Cobra Biologics

3:40pm - 4:00pm20 mins

Intensified and Continuous Processing

SymphonX™ a Generic Downstream Single-Use Purification Rig for Continuous Bioprocessing

Charles Heise, PhD - Senior Staff Scientist BioProcess Strategy & Development, FUJIFILM Diosynth Biotechnologies

3:40pm - 4:00pm20 mins

Speed from Gene to Market

Accelerating Cell Culture Development through Practical Application of Innovation Technologies

Elena Gontarz - Manager of Scientific and Technical Affairs, Thermo Fisher Scientific

3:40pm - 4:00pm20 mins

Manufacturing Strategy & Bioprocessing 4.0

Enabling vaccine and viral vector self sufficiency with modular manufacturing

Ellen Johnson - Enterprise Solutions Technology Leader, Cytiva

4:00pm - 4:30pm30 mins

Cell Line Development & Engineering

Live Speakers Discussion Forum

4:00pm - 4:30pm30 mins

Cell Culture & Upstream Processing

Live Speakers Discussion Forum

4:00pm - 4:30pm30 mins

Recovery & Purification

Live Speakers Discussion Forum

Tony Hitchcock - Technical Director, Cobra Biologics

4:00pm - 4:30pm30 mins

Intensified and Continuous Processing

Live Speakers Discussion Forum

4:00pm - 4:30pm30 mins

Speed from Gene to Market

Live Speakers Discussion Forum

Elena Gontarz - Manager of Scientific and Technical Affairs, Thermo Fisher Scientific

4:00pm - 4:30pm30 mins

Manufacturing Strategy & Bioprocessing 4.0

Live Speakers Discussion Forum

Ellen Johnson - Enterprise Solutions Technology Leader, Cytiva

4:30pm - 5:00pm30 mins

Networking Activity: Culinary Instruction with Local Boston Chef

5:00pm - 5:05pm5 mins

End of Day 2

DAY TWO WATCH LIVE (EST): September 22nd

DAY TWO WATCH LIVE (EST): September 22nd

Get the latest news.As it happens

Get the latest news.
As it happens