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Key Sessions

Laurie Glimcher

Dana-Farber: Cancer in the 21st Century

Dana Farber Cancer Institute

Sarah Arden

A Perspective on the Future of the Biopharmaceutical Manufacturing

Office of Pharmaceutical Quality (OPQ)/Center for Drug Evaluation and Research (CDER)

7:15am - 8:00am
Info

Morning Roundtable Discussions with Light Continental Breakfast / Technology Workshop with Light Continental Breakfast

Registration and Morning Coffee with Round Table Discussions and Technology Workshops

More
Showing of Streams
9:45am - 10:25am

Refreshment Break in the Poster & Exhibit Hall

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Showing of Streams
12:35pm - 1:45pm

Networking Luncheon in the Poster & Exhibit Hall

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Showing of Streams
Showing of Streams
3:15pm - 4:00pm

Refreshment Break in the Poster & Exhibit Hall

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Showing of Streams
5:30pm - 9:00pm

Cocktail Reception & BWB Party

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7:15am - 8:00am 45 mins
Info
Morning Roundtable Discussions with Light Continental Breakfast / Technology Workshop with Light Continental Breakfast

Registration and Morning Coffee with Round Table Discussions and Technology Workshops

8:00am - 8:10am 10 mins
Plenary Session
Chairperson’s Opening Remarks
8:10am - 8:45am 35 mins
Plenary Session
KEYNOTE ADDRESS: In Integrated Design Approach for the Development and Manufacture of High Quality Biologics
  • Dr. James Thomas, Ph.D. - CEO, Just Biotherapeutics
8:45am - 9:45am 60 mins
Plenary Session
Dana-Farber: Cancer in the 21st Century
  • Speaker Laurie Glimcher - President & CEO, Dana Farber Cancer Institute
9:45am - 10:25am 40 mins
Refreshment Break in the Poster & Exhibit Hall
10:25am - 10:30am 5 mins
Cell Culture & Upstream Processing
Chairperson's Remarks
10:25am - 10:30am 5 mins
Speed from Gene to Market
Chairperson's Remarks
10:25am - 10:30am 5 mins
Recovery & Purification
Chairperson's Remarks
10:25am - 10:30am 5 mins
Intensified and Continuous Processing
Chairperson's Remarks
10:25am - 10:30am 5 mins
Manufacturing Strategy
Chairperson's Remarks
10:25am - 10:30am 5 mins
Analytical & Quality
Chairperson's Remarks
10:25am - 11:05am 40 mins
Info
Novel Technologies – Downstream Processing
Novel Tech Showcase
10:30am - 11:00am 30 mins
Info
Cell Culture & Upstream Processing
Approach to Identify and Control Product Attributes In Cell Culture Perfusion System
  • Prasad Pathange - Senior Manager, Bayer U.S.

During a routine continuous cell culture campaign, which can last up to several weeks or months, a change in product profile at drug substance stage was observed. A comprehensive approach to evaluate the whole production process starting from raw materials, vial thaw, cell culture and ending in purification process was used to get to root cause. After a thorough evaluation, a particular aspect of the functioning of the cell retention system was determined as the cause for the change in the product profile. By gaining greater insights in to cell retention mechanism, critical parameters that affect product attributes were identified. After implementing adjustments to the cell retention system, the product profile was restored.

10:30am - 11:00am 30 mins
Speed from Gene to Market
KEYNOTE ADDRESS - The Impact of Speed on Quality
  • Vaughn Tunstall - Site Head, Quality, Oceanside, Genentech, Inc
10:30am - 11:00am 30 mins
Recovery & Purification
Meeting Manufacturability Challenges for Antibody-Drug Conjugates
  • Michaela Wendeler, Ph.D. - Principal Scientist, Biopharmaceutical Development, MedImmune
10:30am - 11:00am 30 mins
Intensified and Continuous Processing
Approach to Identify and Control Product Attributes in Cell Culture Perfusion System
  • Prasad Pathange - Senior Manager, Bayer U.S.
10:30am - 11:00am 30 mins
Manufacturing Strategy
Meeting Manufacturability Challenges for Antibody-Drug Conjugates
  • Michaela Wendeler, Ph.D. - Principal Scientist, Biopharmaceutical Development, MedImmune
10:30am - 11:00am 30 mins
Analytical & Quality
KEYNOTE ADDRESS - The Impact of Speed on Quality
  • Vaughn Tunstall - Site Head, Quality, Oceanside, Genentech, Inc
11:00am - 11:30am 30 mins
Cell Culture & Upstream Processing
How to Ensure Clonality: A Case Study by Amgen
  • Jonathan Diep - Scientist, Amgen
11:00am - 11:30am 30 mins
Speed from Gene to Market
Evaluation of PAT Co-Laboratory Process Development Model
  • Zachary Houle - Senior Development Specialist, Upstream Process Development, Takeda
11:00am - 11:30am 30 mins
Recovery & Purification
Viral Vector Recovery: Design of Adsorption based Separations to Maintain Infectivity
  • Dan Bracewell, Ph.D. - Professor of Bioprocess Analysis, University College London
11:00am - 11:30am 30 mins
Intensified and Continuous Processing
How to Ensure Clonality: A Case Study by Amgen
  • Jonathan Diep - Scientist, Amgen
11:00am - 11:30am 30 mins
Info
Manufacturing Strategy
Flexible Manufacturing Strategies to Support DART® Molecules and Monoclonal Antibodies
  • Tom Spitznagel - Senior Vice President, BioPharmaceutical Development and Manufacturing, MarcroGenics, Inc.

MacroGenics recently expanded its manufacturing capacity to support a broad range of molecules spanning both traditional antibodies as well as more novel modalities including bispecific DART molecules.  Design and operational strategies will be discussed that focus on leveraging single use disposable technologies as well as ensuring a highly flexible manufacturing facility.

11:00am - 11:30am 30 mins
Analytical & Quality
Evaluation of PAT Co-Laboratory Process Development Model
  • Zachary Houle - Senior Development Specialist, Upstream Process Development, Takeda
11:30am - 12:00pm 30 mins
Cell Culture & Upstream Processing
A Process Identification in Cell Culture
  • Steffen Kreye, Ph.D. - USP Process Development Expert, Bayer
11:30am - 12:00pm 30 mins
Speed from Gene to Market
How to Apply Analytical Approaches to Speed Up Cell and Gene Therapy Development
  • David Hambly, Ph.D. - Director, Analytical and Vector Development, Atara Biotherapeutics
11:30am - 12:00pm 30 mins
Recovery & Purification
Overcoming Downstream Challenges Created by Cell Free Expression Systems
  • David Gruber - Head of Downstream Process Development, Ipsen
11:30am - 12:00pm 30 mins
Intensified and Continuous Processing
A Process Identification in Cell Culture
  • Steffen Kreye, Ph.D. - USP Process Development Expert, Bayer
11:30am - 12:00pm 30 mins
Info
Manufacturing Strategy
Challenges and Opportunities in the Development of a Messenger RNA Manufacturing Process
  • Peter Wojciechowski - Head Drug Substance Process Development, Moderna Therapeutics

Moderna is a leader in the discovery and development of messenger RNA (mRNA) therapeutics and vaccines. As of March 2019 Moderna has 20 programs in its pipeline, 11 in clinical trials and a new GMP manufacturing facility in Norwood MA was opened in the summer of 2018. mRNA is the active pharmaceutical ingredient (API) in this new class of medicines and its manufacture represents new challenges and opportunities for a biopharmaceutical industry more familiar with the production of proteins. The typical mRNA manufacturing process involves an in vitro transcription reaction to generate the mRNA followed by an enzymatic capping reaction and several chromatographic and membrane unit operations. Challenges being faced in designing these new processes involve the identification and understanding of critical quality attributes and the bulk sourcing and quality control of novel raw materials. The opportunities presented include the abilities to create a true platform process for a wide range of APIs, a potentially lower cost of goods, fully defined raw materials, well-characterized API and minimization of adventitious agent risks. This presentation will provide an overview of these opportunities and challenges as well as an update on Moderna’s progress towards development of commercial mRNA manufacturing processes.

11:30am - 12:00pm 30 mins
Analytical & Quality
How to Apply Analytical Approaches to Speed Up Cell and Gene Therapy Development
  • David Hambly, Ph.D. - Director, Analytical and Vector Development, Atara Biotherapeutics
12:05pm - 12:35pm 30 mins
Info
Cell Culture & Upstream Processing
Scientific Track Presentations
  • Joe Orlando, Ph.D. - Principal Scientist, MilliporeSigma
12:05pm - 12:35pm 30 mins
Speed from Gene to Market
Scientific Track Presentations
12:05pm - 12:35pm 30 mins
Info
Recovery & Purification
Scientific Track Presentations
12:05pm - 12:35pm 30 mins
Info
Intensified and Continuous Processing
Scientific Track Presentations
12:05pm - 12:35pm 30 mins
Info
Manufacturing Strategy
Scientific Track Presentations
12:05pm - 12:35pm 30 mins
Analytical & Quality
Scientific Track Presentations
12:35pm - 1:45pm 70 mins
Networking Luncheon in the Poster & Exhibit Hall
1:45pm - 2:15pm 30 mins
Info
Cell Culture & Upstream Processing
Robust N-1 Perfusion Process Development for Intensified Fed-Batch Processes: Achieving Consistent N-1 Growth to Target High Cell Density Inoculation
  • Charles Hill - Associate Engineer/Scientist, Bristol-Myers Squibb
  • Robust N-1 performance using dynamic perfusion control strategy
  • Cost effectiveness of dynamic control vs. constant perfusion rate
  • Optimization of perfusion media through small-scale screening studies
  • Lessons learned from tech transfer perfusion seed reactors to manufacturing
  • Scale-down modelling of ATF performance at manufacturing scale
  • Reduction of bioreactor footprint through maximization of split ratios
  • Comparing N-1 operation type in production bioreactor
1:45pm - 2:15pm 30 mins
Speed from Gene to Market
Accelerated Late Stage Process Development for Polatuzumab Vedotin, An Antibody Drug Conjugate for Treating Non-Hodgkin Lymphoma
  • Andy Lin, Ph.D. - Senior Technical Development Team Leader, Genentech, Inc.
1:45pm - 2:15pm 30 mins
Info
Recovery & Purification
Integrated Continuous Bioprocessing – A Small Company Approach for Phase 1 CTM Manufacturing
  • Maarten Pennings - Chief Technology Officer, Biosana Pharma

Maarten Pennings received his M.Sc. in Bioprocess Technology from Wageningen University and has 20 years of experience in the development of biopharmaceuticals. He spent 12 years at Xendo (now ProPharma) as a consultant process development, worked in projects on antibiotics, antibodies and viral vaccines. He has also been working on the development of continuous manufacturing in biopharma since 1999 and is a co-inventor of the BioSMB. For the past 4 years he has been in charge of process development and manufacturing for BiosanaPharma, a company developing biosimilar antibodies produced with a continuous manufacturing platform from perfusion bioreactor to bulk drug substance formulation.

1:45pm - 2:15pm 30 mins
Info
Intensified and Continuous Processing
Integrated Continuous Bioprocessing – A Small Company Approach for Phase 1 CTM Manufacturing
  • Maarten Pennings - Chief Technology Officer, Biosana Pharma

Maarten Pennings received his M.Sc. in Bioprocess Technology from Wageningen University and has 20 years of experience in the development of biopharmaceuticals. He spent 12 years at Xendo (now ProPharma) as a consultant process development, worked in projects on antibiotics, antibodies and viral vaccines. He has also been working on the development of continuous manufacturing in biopharma since 1999 and is a co-inventor of the BioSMB. For the past 4 years he has been in charge of process development and manufacturing for BiosanaPharma, a company developing biosimilar antibodies produced with a continuous manufacturing platform from perfusion bioreactor to bulk drug substance formulation.

1:45pm - 2:15pm 30 mins
Info
Manufacturing Strategy
A Perspective on the Future of the Biopharmaceutical Manufacturing
  • Sarah Arden - Team Lead (Acting), New Technologies and Innovation Group: Manufacturing, Methods Development, Modeling/Simulations Science and Research Staff, Office of Pharmaceutical Quality (OPQ)/Center for Drug Evaluation and Research (CDER)

Over the past two decades pharmaceutical and biotherapeutic drug developers have been evolving their manufacturing platforms to consistently produce products that meet both consumer demand and the high quality requirements expected by health authorities and the public. As drug developers continue to optimize their production platforms and integrate digitalized infrastructure to more efficiently capture and analyze data for enhanced controls, Biomanufacturing 4.0 and beyond may be realized.

1:45pm - 2:15pm 30 mins
Analytical & Quality
Leveraging Historical Knowledge & Data to Define Analytical Target Profiles for Early-Phase Analytical Method Development
  • Ruth Frenkel - Scientist I, Biogen
2:15pm - 2:45pm 30 mins
Cell Culture & Upstream Processing
Case Study on Upstream Process Development from Alexion Pharmaceuticals
  • Wei-Chien Hung - Development Scientist, Alexion Pharmaceuticals, Inc.
2:15pm - 2:45pm 30 mins
Speed from Gene to Market
Developing CMC Strategies to Advance a Gene Therapy Pipeline
  • Rajiv Gangurde, Ph.D. - Director, CMC, Voyager Therapeutics
2:15pm - 2:45pm 30 mins
Recovery & Purification
A Continuous Precipitation Process for Target Capture
  • Todd Przybycien - Professor, RPI
2:15pm - 2:45pm 30 mins
Intensified and Continuous Processing
Latest Advances and Future Applications for Continuous Precipitation Processes
  • Todd Przybycien - Professor, RPI
2:15pm - 2:45pm 30 mins
Info
Manufacturing Strategy
When Digital Meets Biotech
  • Geoffrey Pot - VP Operations, Takeda

Companies are utilizing new advances in technology and are developing their employees to be equipped with the skill sets needed for next generation manufacturing. This allows that all data is captured and integrated to make predictive analytics feasible which will maximize your process efficiencies and reduce your vulnerabilities. It will not only ensure companies are more competitive, agile, robust and efficient, it will also allow companies to meet global demand and provide greater access to commercial drug products as it lowers costs to make the product. As such, it is critical for companies to invest in projects that lead to digital transformation.

In this presentation we want to bring you closer in the digital world. From data analytics, to augmented reality and digital twins… Welcome in a new fascinating world!

2:15pm - 2:45pm 30 mins
Info
Analytical & Quality
Automation and High Throughput Analytics: Accelerating Process Development and Characterization
  • Lintao Wang, Ph.D. - Associate Director, Immunogen

Process development of biotherapeutical agents requires screening many process conditions. Automation and high throughput analytics have been implemented to shorten the analytical turn-arounds to support process developmental more efficiently. Bridging studies between high-throughput methods and other analytical methods were performed to ensure data quality.

2:45pm - 3:15pm 30 mins
Info
Tech Workshop 1
Technology Workshops
2:45pm - 3:15pm 30 mins
Info
Tech Workshop 2
Technology Workshops
2:45pm - 3:15pm 30 mins
Info
Tech Workshop 3
Technology Workshops
2:45pm - 3:15pm 30 mins
Info
Tech Workshop 4
Technology Workshops
2:45pm - 3:15pm 30 mins
Info
Tech Workshop 5
Technology Workshops
3:15pm - 4:00pm 45 mins
Refreshment Break in the Poster & Exhibit Hall
4:00pm - 4:30pm 30 mins
Cell Culture & Upstream Processing
Implementation of Real-Time Monitoring Methods for Cell Density and Product Quality in Cell Culture Bioreactors
  • A Representative from Amgen, .
4:00pm - 4:30pm 30 mins
Recovery & Purification
Novel Single-Use, High Capacity and Flux Tangential Flow Depth Filter for mAb Batch Harvest
4:00pm - 4:30pm 30 mins
Intensified and Continuous Processing
Using 3D Imprinted Design for Improved Unit Operations for a Crystallization Process
4:00pm - 4:30pm 30 mins
Manufacturing Strategy
Leveraging Industry 4.0 Technology in Bioprocessing
  • Jonathan Souquet, Ph.D. - Head of Technology & Innovation, Global Development & Launch, Merck
4:00pm - 4:30pm 30 mins
Analytical & Quality
Implementation of Real-Time Monitoring Methods for Cell Density and Product Quality in Cell Culture Bioreactors
  • A Representative from Amgen, .
4:00pm - 4:20pm 20 mins
Info
Novel Technology Showcase - Analytical Technologies
Novel Tech Showcase
4:30pm - 5:00pm 30 mins
Info
Cell Culture & Upstream Processing
Case Study: Application of Raman Spectroscopy for Online Process Monitoring and Quality Control in Large Scale/ Commercial Manufacturing
  • Case study on how industry has applied Raman spectroscopy for cell culture process monitoring in large scale / commercial manufacturing
  • Quality attributes which can be monitored through use of Raman probes
  • Where has Raman spectroscopy been applied in GMP environments?
  • Measuring sensitivity of media and composition changes
  • Overcoming issues in sensitivity and difficulties faced using Raman probes
4:30pm - 5:00pm 30 mins
Info
Speed from Gene to Market
Accelerating Late Stage Development for Breakthrough Designated Product

A Representative from Amicus

4:30pm - 5:00pm 30 mins
Recovery & Purification
Industrialization Aspects of Membrane Affinity Technology
  • Krunal Mehta - Senior Scientist, Amgen
4:30pm - 5:00pm 30 mins
Info
Intensified and Continuous Processing
Integrated Continuous Biomanufacturing (ICB) and Complex mAb Modalities: Quality with Productivity

A Representative from Sanofi

4:30pm - 5:00pm 30 mins
Info
Manufacturing Strategy
Shifting the Data Culture, from Grassroots to Strategic Efforts
  • Myra Coufal, PhD - Digital Integration & Predictive Technologies (DIPT), Process Development, Amgen

An element of a Digital Transformation is changing people’s perceptions and expectations of data. While shifting this Data Culture is not trivial, we believe our digital systems and models are best utilized when they are accessible to a capable workforce at-large instead of a niche of few experts. We will discuss the journey updating our Data Culture in aligning it with the Digital Transformation efforts.

4:30pm - 5:00pm 30 mins
Info
Analytical & Quality
Case Study: Application of Raman Spectroscopy for Online Process Monitoring and Quality Control in Large Scale/ Commercial Manufacturing
  • Case study on how industry has applied Raman spectroscopy for cell culture process monitoring in large scale / commercial manufacturing
  • Quality attributes which can be monitored through use of Raman probes
  • Where has Raman spectroscopy been applied in GMP environments?
  • Measuring sensitivity of media and composition changes
  • Overcoming issues in sensitivity and difficulties faced using Raman probes
5:00pm - 5:30pm 30 mins
Info
Cell Culture & Upstream Processing
Continuous Protein Size Monitoring from Perfusion Cell Cultures Using Nanofluidics
  • Jongyoon Han - Senior Applications Scientist and Northeast Regional Manager, Massachusetts Institute of Technology

In this presentation, we will present our ongoing research effort toward real-time, online protein critical quality attributes (CTA) monitoring directly from high cell density CHO cell culture reactors, over a long (>2 weeks) period of time. Critical enabling components include continuous protein sample preparation system, and nanofluidic continuous protein sizing system that can be used for both size analytics as well as homogeneous binding assays. Combined with other process parameters such as cell density and viability, real-time protein sizing and other information can reveal new information regarding ways to improve the overall productivity of the perfusion bioreactors.

5:00pm - 5:30pm 30 mins
Speed from Gene to Market
PANEL DISCUSSION: Balancing Speed, Cost, and Quality to Launch
5:00pm - 5:30pm 30 mins
Recovery & Purification
EASY Process: A Full Flowthrough & Disposable mAb Purification Process
  • Benoit Mothes, PharmD - Global DSP Skill Center Head, Sanofi
5:00pm - 5:30pm 30 mins
Info
Intensified and Continuous Processing
Design Principles and Performance Data of an Integrated Continuous Antibody Downstream Process

A Representative from Bayer AG, Germany

5:00pm - 5:30pm 30 mins
Info
Manufacturing Strategy
Digital Transformation and Bioprocessing 4.0 - The Path to Smart Manufacturing
  • Richard Braatz, PhD - Edwin R. Gilliland Professor, Faculty Research Officer, Massachusetts Institute of Technology

This presentation describes ways to leverage and implement Industry 4.0 technologies in biopharmaceutical manufacturing. An accelerated process development workflow is described that employs micro-scale technologies, modular unit operations with integrated process control and monitoring systems, systems integration, and full plant automation. How to best develop and transfer knowledge between steps in the workflow via first-principles models, data analytics, and machine learning is discussed.

5:00pm - 5:30pm 30 mins
Info
Analytical & Quality
Continuous Protein Size Monitoring from Perfusion Cell Cultures Using Nanofluidics
  • Jongyoon Han - Senior Applications Scientist and Northeast Regional Manager, Massachusetts Institute of Technology

In this presentation, we will present our ongoing research effort toward real-time, online protein critical quality attributes (CTA) monitoring directly from high cell density CHO cell culture reactors, over a long (>2 weeks) period of time. Critical enabling components include continuous protein sample preparation system, and nanofluidic continuous protein sizing system that can be used for both size analytics as well as homogeneous binding assays. Combined with other process parameters such as cell density and viability, real-time protein sizing and other information can reveal new information regarding ways to improve the overall productivity of the perfusion bioreactors.

5:30pm - 9:00pm 210 mins
Cocktail Reception & BWB Party