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Sep 07
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7:15am - 7:45am 30 mins
Main Conference
Technology Workshop with Light Continental Breakfast
7:55am - 8:00am 5 mins
Cell Culture & Upstream Processing
Chairperson's Remarks
  • Patrick Hossler, PhD - Principal Research Scientist, AbbVie Inc.
more
7:55am - 8:00am 5 mins
Recovery & Purification
Chairperson's Remarks
  • Natraj Ram, PhD - Associate Director, Abbott Bioresearch Center
more
7:55am - 8:00am 5 mins
Bioprocessing 4.0: Smart Manufacturing
Chairperson's Remarks
  • Thomas Seewoester, PhD - Executive Director, Clinical Drug Substance Manufacturing, Amgen, Inc.
  • Lynne Frick - Founder, Bioguides
more
7:55am - 8:00am 5 mins
Analytical & Quality
Chairperson's Remarks
  • Balaji Viswanathan - Principal Scientist, Pfizer Biotherapeutics
more
7:55am - 8:00am 5 mins
Speed from Gene to Market
Chairperson's Remarks
  • Sigma Mostafa, PhD - Vice President, Upstream & Downstream Process Development, KBI Biopharma
more
8:00am - 8:25am 25 mins
Cell Culture & Upstream Processing
AMBR250 as a High Throughput Scale-down Model for a Typical Monoclonal Antibody Manufacturing Process
  • Jie Xu, PhD - Senior Scientist, Merck
more
8:00am - 8:25am 25 mins
Recovery & Purification
Integration of Fully Flow-through Mode for Developing Biosimilar Downstream Process
  • Emre Burak Erkal - Upstream and Downstream Process Engineer, Turgut Pharmaceuticals
more
8:00am - 8:40am 40 mins
Bioprocessing 4.0: Smart Manufacturing
Digital Transformation, New Technology and PAT Implementation
  • Myra Coufal, PhD - Principal Scientist, Process Analytics, Digital Integration and Predictive Technologies, Amgen
more
8:00am - 8:25am 25 mins
Analytical & Quality
Phase-Appropriate Analytical Method Validation: Where, When, and Why?
  • Mary Beth Pelletier, PhD - Associate Director, QC Analytical Technology, Biogen
more

Having a strong phase-appropriate method validation strategy is key not only to ensuring that the suitable quantity and quality of data are available at the appropriate stage of development, but also to optimizing investment of resources during development and to preparing for lifecycle management of the validated method. An overview of Biogen’s strategy for biologics will be presented, as well as multiple lessons learned outlining how implementation of this approach has provided efficiencies and enabled streamlined lifecycle maintenance of methods.

8:00am - 8:25am 25 mins
Speed from Gene to Market
Moving to BLA with Pools Without Proof of Clonality - How Does it Impact Timeline to BLA?
8:25am - 8:50am 25 mins
Cell Culture & Upstream Processing
Modeling of a Perfusion Process from Bench to 1000L Scale
  • Jin Yin, PhD - Director, Biologics Process Development, Momenta Pharmaceuticals
more
8:25am - 8:50am 25 mins
Recovery & Purification
Evaluating Biologics Process Comparability through Harvest and Drug Substance Quality Attributes: A Case Study
  • Dong Yang, PhD - Engineer II, Bristol-Myers Squibb
more
8:25am - 8:50am 25 mins
Analytical & Quality
Analytical Lifecycle Management. Preparing Test Methods for the Commercial QC Laboratory
  • Vesselin Mitaksov, PhD - Senior Scientist, Pfizer
more

Analytical methods for biologics testing evolve throughout drug development.  This evolution is guided by key considerations for method implementation in the commercial QC lab.  Case studies will be presented on how method lifecycle management assures successful transition of new methods from support of clinical development to support of commercial manufacture.

8:25am - 8:50am 25 mins
Speed from Gene to Market
Why Speed to IND Can Cause Major Issues and Risks Later in Development
  • Regina Au, MBA, MIM - Principal, BioMarketing Insight
more
8:40am - 9:15am 35 mins
Bioprocessing 4.0: Smart Manufacturing
Industry 4.0 Increasing Quality and Predictability in BioPharma
  • Dirk Voelkel, PhD - Chief Technology Officer, Innovation and Analytics, GE Healthcare Life Science
more

By 2020, 30 billion machines will be connected to the industrial internet and this will transform the way people and machines interact by using data and analytics to drive efficiency, accelerate productivity and achieve operational excellence. A convergence of trends and technologies are making it possible to realize real benefits. Industry 4.0 has the potential to positively impact the BioPharma industry. In case studies, we will show how combining brilliant machines with best-in-class digital industrial technologies delivers valuable new insights that were not before possible.

8:50am - 9:15am 25 mins
Cell Culture & Upstream Processing
Development and Characterization of Microporous Spargers in Single Use Bioreactors (SUBs) at Bench Scale
  • William Tran, PhD - Scientist, Merck & Co.
more
8:50am - 9:15am 25 mins
Recovery & Purification
Raw Material Lot Variability Challenges During Manufacturing of Biosimilar mAb: Case Studies
  • Sekhar Reddy Atturi, MSc., M.Tech - Manager, Biocon Limited
more
8:50am - 9:15am 25 mins
Analytical & Quality
Analytical Lifecycle Management Program to Support Commercial Processes
  • Debora Aguiar - Director, Specialty Care Quality, Sanofi Genzyme
more

An overview of the Analytical Lifecycle and components necessary for a Continuous Performance Verification system that will support a robust Analytical Lifecycle Management program will be presented. Learning objectives include: 1) Use of risk-based approaches to support Analytical Lifecycle activities and 2) Methodologies to employ for identifying when analytical lifecycle activities are warranted.

8:50am - 9:15am 25 mins
Speed from Gene to Market
PANEL DISCUSSION – The Downside to Speed to IND – Risks and Impact on Later Development
  • Susan Jones, PhD - Vice President and Principal Consultant, BioProcess Technology Consultants
more
9:15am - 9:45am 30 mins
Presentation 1
Concurrent Scientific & Technology Presentations 1
9:15am - 9:45am 30 mins
Presentations 2
Concurrent Scientific & Technology Presentations 2
9:15am - 9:45am 30 mins
Presentations 3
Concurrent Scientific & Technology Presentation 3
9:15am - 9:45am 30 mins
Presentations 4
Concurrent Scientific & Technology Presentations 4
9:15am - 9:45am 30 mins
Presentations 5
Concurrent Scientific & Technology Presentations 5
9:45am - 10:30am 45 mins
Refreshment Break in the Poster & Exhibit Hall
10:30am - 10:50am 20 mins
Cell Culture & Upstream Processing
Opportunities for Modification of Glycan Structures at Various Stages During a Bioprocess
  • Michael Butler, MSc, PhD - Chief Scientific Officer, National Institute of Bioprocessing Research & Training (NIBRT)
more
10:30am - 11:00am 30 mins
Recovery & Purification
Characterizing and Optimizing Depth Filtration of a Therapeutic Protein
  • Jessica Kenney - Development Associate III, Alexion Pharmaceuticals
more
10:30am - 11:00am 30 mins
Bioprocessing 4.0: Smart Manufacturing
Digital Transformation in Manufacturing/Factories and Industry 4.0 Concepts: Potential Applications in Biologics Manufacturing and Biologics Process Development
  • Andrew Whytock - Head of Digitalization and Innovation, Business Segment Pharma, Siemens
more

Digitalization is changing manufacturing. Market changes are driving a transformation of biopharamceutical manufacturing from R&D to manufacturing and supply chain.This presentation gives an insight to how biopharma is using technology to change its business and embrace the digital transformation, and includes concrete examples of current innovative projects in the industry.

10:30am - 11:00am 30 mins
Analytical & Quality
Digital Transformation in Manufacturing/Factories and Industry 4.0 Concepts: Potential Applications in Biologics Manufacturing and Biologics Process Development
  • Andrew Whytock - Head of Digitalization and Innovation, Business Segment Pharma, Siemens
more

Digitalization is changing manufacturing. Market changes are driving a transformation of biopharamceutical manufacturing from R&D to manufacturing and supply chain.This presentation gives an insight to how biopharma is using technology to change its business and embrace the digital transformation, and includes concrete examples of current innovative projects in the industry.

10:30am - 11:00am 30 mins
Novel Technology Showcase- Disruptive Upstream Technologies
Speaker TBA
10:30am - 11:00am 30 mins
TBA
Speaker TBA
10:30am - 11:00am 30 mins
Speed from Gene to Market
Utilizing Regulatory Guidance and Technology to Accelerate Drug Development
  • Fredrik Asell, MSc - Head of Quality, Supply America, AstraZeneca
more
10:50am - 11:10am 20 mins
Cell Culture & Upstream Processing
Challenges in Control of pH During Routine Upstream Manufacturing of Biosimilar mAb – Case Studies
  • Kala Chandramouli - Head, Manufacturing Sciences and Technology – Biosimilar Mabs, Biocon
more
11:00am - 11:30am 30 mins
Recovery & Purification
How to Address Unexpected Absorption Phenomena Due to Reduced Impurity Clearance in Purification Process Development by Using Analytical Techniques
  • George Weeden Jr. - Process Engineer III, Sanofi
more
11:00am - 11:30am 30 mins
Bioprocessing 4.0: Smart Manufacturing
PANEL DISCUSSION: Applying Industry 4.0 Concepts to Improve Biologics Manufacturing
  • Thomas Seewoester, PhD - Executive Director, Clinical Drug Substance Manufacturing, Amgen, Inc.
  • Lynne Frick - Founder, Bioguides
more
11:00am - 11:30am 30 mins
Analytical & Quality
PANEL DISCUSSION: Applying Industry 4.0 Concepts to Improve Biologics Manufacturing
  • Thomas Seewoester, PhD - Executive Director, Clinical Drug Substance Manufacturing, Amgen, Inc.
  • Lynne Frick - Founder, Bioguides
more
11:00am - 11:30am 30 mins
Novel Technology Showcase- Disruptive Upstream Technologies
Speaker TBA
11:00am - 11:30am 30 mins
TBA
Speaker TBA
11:00am - 11:30am 30 mins
Speed from Gene to Market
Integrated Biologics Development and Manufacturing from Early Phase to PPQ and Product Launch
  • Victor Vinci, PhD - Vice President, Product Development, Catalent Biologics
more
11:10am - 11:30am 20 mins
Cell Culture & Upstream Processing
Raman Spectroscopy Monitoring of Product Quality in CHO Cell Culture
  • Brian Horvath, PhD - Senior Scientist and Senior Group Leader, Genentech, a member of the Roche Group, USA
more
11:35am - 12:05pm 30 mins
Workshop
Technology Workshop 1
11:35am - 12:05pm 30 mins
Workshop 2
Technology Workshop 2
11:35am - 12:05pm 30 mins
Workshop 3
Technology Workshop 3
11:35am - 12:05pm 30 mins
Workshop 4
Technology Workshop 4
11:35am - 12:05pm 30 mins
Workshop 5
Technology Workshop 5
12:05pm - 1:25pm 80 mins
Networking Luncheon in the Poster & Exhibit Hall
1:25pm - 1:30pm 5 mins
Cell Culture & Upstream Processing
Chairperson's Remarks
1:25pm - 1:30pm 5 mins
Recovery & Purification
Chairperson's Remarks
1:25pm - 1:30pm 5 mins
Bioprocessing 4.0: Smart Manufacturing
Chairperson's Remarks
  • Thomas Seewoester, PhD - Executive Director, Clinical Drug Substance Manufacturing, Amgen, Inc.
  • Lynne Frick - Founder, Bioguides
more
1:25pm - 1:30pm 5 mins
Analytical & Quality
Chairperson's Remarks
  • Thomas Seewoester, PhD - Executive Director, Clinical Drug Substance Manufacturing, Amgen, Inc.
  • Lynne Frick - Founder, Bioguides
more
1:25pm - 1:30pm 5 mins
TBA
Chairperson's Remarks
1:25pm - 1:30pm 5 mins
Speed from Gene to Market
Chairperson's Remarks
1:30pm - 2:00pm 30 mins
Cell Culture & Upstream Processing
Development of a Scalable Suspension Cell Culture Platform for the Manufacturing of Allogenic Exosome Biotherapeutics
  • Scott Estes, PhD - Vice President, Codiak Biosciences
more
1:30pm - 1:50pm 20 mins
Recovery & Purification
Chromatography-Free Capture of Antibodies
  • Kelli Luginbuhl, PhD - Chief Scientific Officer, Isolere Bio, Inc
more
1:30pm - 2:00pm 30 mins
Bioprocessing 4.0: Smart Manufacturing
Biomanufacturing 4.0: Unlocking the Drivers to the Future State of Biomanufacturing
  • Jeff Odum - Managing Partner, Strategic Manufacturing Concept Group and Global Technology Partner, NNE
  • Morten Munk - Global Technology Partner, NNE
more

As the Biomanufacturing Industry moves into its next phase of rapid growth and diversity, manufacturing organizations are seeking a balance between innovation and risk, flexibility and agility, efficiency and utilization. All of this on a backdrop of cost pressures and speed. This session will present a model on how to address these challenges and some of the innovative technologies and platforms that will drive the Industry to the future state. Included will be a case study on implementing advanced robotics, discussions on the implementation of digitalization & Industry 4.0, and examples of projects implementing enabling/disruptive technologies to define future manufacturing capabilities .

1:30pm - 2:00pm 30 mins
Analytical & Quality
Biomanufacturing 4.0: Unlocking the Drivers to the Future State of Biomanufacturing
  • Jeff Odum - Managing Partner, Strategic Manufacturing Concept Group and Global Technology Partner, NNE
  • Morten Munk - Global Technology Partner, NNE
more

As the Biomanufacturing Industry moves into its next phase of rapid growth and diversity, manufacturing organizations are seeking a balance between innovation and risk, flexibility and agility, efficiency and utilization. All of this on a backdrop of cost pressures and speed. This session will present a model on how to address these challenges and some of the innovative technologies and platforms that will drive the Industry to the future state. Included will be a case study on implementing advanced robotics, discussions on the implementation of digitalization & Industry 4.0, and examples of projects implementing enabling/disruptive technologies to define future manufacturing capabilities .

1:30pm - 2:00pm 30 mins
TBA
Speaker TBA
1:30pm - 2:00pm 30 mins
Speed from Gene to Market
Rapid PC Studies Methodology, PC Data Package in 6 Months
  • Shahid Rameez, Ph.D. - Principal Scientist, Process Development, KBI Biopharma Inc.
more
1:50pm - 2:10pm 20 mins
Recovery & Purification
A Purification Platform Technology for Non-Sterilizable Viral Vaccines Using a Disposable and Fully Closed System
  • Yelin Xiong, PhD - Senior Scientist, Manager, Sanofi Pasteur
more
2:00pm - 2:30pm 30 mins
Cell Culture & Upstream Processing
Expression Challenges of Engineered Products
  • Susan Jones, PhD - Vice President and Principal Consultant, BioProcess Technology Consultants
more
2:00pm - 2:30pm 30 mins
Bioprocessing 4.0: Smart Manufacturing
From Process Development to Commercial Manufacturing: Approaching the Implementation of Operational Technology Solutions in Personalized Medicine
  • Gloria Gadea Lopez, PhD - Associate Director, Shire
more


As personalized medicine advances from R&D towards clinical and commercial manufacturing, companies are evaluating their business process and considering investments on digital technology to support their operations. This presentation will provide insights into best practices towards the successful implementation of systems for supply chain, data analytics and manufacturing execution. In addition to technology-specific recommendations, emphasis will be placed on methodologies and organizational aspects of these projects.

2:00pm - 2:30pm 30 mins
Analytical & Quality
From Process Development to Commercial Manufacturing: Approaching the Implementation of Operational Technology Solutions in Personalized Medicine
  • Gloria Gadea Lopez, PhD - Associate Director, Shire
more


As personalized medicine advances from R&D towards clinical and commercial manufacturing, companies are evaluating their business process and considering investments on digital technology to support their operations. This presentation will provide insights into best practices towards the successful implementation of systems for supply chain, data analytics and manufacturing execution. In addition to technology-specific recommendations, emphasis will be placed on methodologies and organizational aspects of these projects.

2:00pm - 2:30pm 30 mins
TBA
Speaker TBA
2:00pm - 2:30pm 30 mins
Speed from Gene to Market
Understanding the Path from Process Characterization to Process Validation Completion- Dealing with Orphan and Fast Track Molecules
2:10pm - 2:30pm 20 mins
Recovery & Purification
A New Depletion Technology for Mid-Stream and Down-Stream Purification
  • Benoit Mothes, PharmD - Head, Sanofi
  • Fabien Rousset - Head of Bioseparations, Chiral Technologies Europe
more
2:30pm - 3:00pm 30 mins
Cell Culture & Upstream Processing
Extended Perfusion Development for Increased Bioreactor Productivity with a Novel Therapeutic
  • Jeff Underhill - Associate Scientist, Amgen
more
2:30pm - 2:50pm 20 mins
Recovery & Purification
Harvest Technologies Using Acoustic Wave Separation
  • Steven Wudyka - Senior Process Engineer, Momenta Pharmaceuticals
more
2:30pm - 3:00pm 30 mins
Bioprocessing 4.0: Smart Manufacturing
Late Breaking Presentation
2:30pm - 3:00pm 30 mins
Analytical & Quality
Late Breaking Presentation
2:30pm - 3:00pm 30 mins
TBA
Speaker TBA
2:30pm - 3:00pm 30 mins
Speed from Gene to Market
Fast-Track Process Development, Technology Transfer and Scale-Up Support of Speed to Market
3:00pm - 3:05pm 5 mins
Close of BPI 2018
Showing of Streams
Showing of Streams
Showing of Streams
9:45am - 10:30am

Refreshment Break in the Poster & Exhibit Hall

Showing of Streams
Showing of Streams
12:05pm - 1:25pm

Networking Luncheon in the Poster & Exhibit Hall

Showing of Streams
3:00pm - 3:05pm
Close of BPI 2018

Close of BPI 2018