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Sep 07
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7:20am - 7:50am 30 mins
Info
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.
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
7:55am - 8:00am 5 mins
Recovery & Purification
Chairperson's Remarks
  • Natraj Ram, PhD - Associate Director, Abbott Bioresearch Center
7:55am - 8:00am 5 mins
Analytical & Quality
Chairperson's Remarks
  • Balaji Viswanathan - Principal Scientist, Pfizer Biotherapeutics
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
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
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?
8:00am - 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
8:00am - 8:25am 25 mins
Info
Analytical & Quality
Phase-Appropriate Analytical Method Validation: Where, When, and Why?
  • Mary Beth Pelletier, PhD - Associate Director, QC Analytical Technology, Biogen

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 - 8:40am 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
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
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
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
8:25am - 8:50am 25 mins
Info
Analytical & Quality
Analytical Lifecycle Management. Preparing Test Methods for the Commercial QC Laboratory
  • Daniel Hemminghaus - QA Manager, Pfizer

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.

8:40am - 9:15am 35 mins
Info
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

Industry 4.0 is a reality that is impacting the BioPharma industry in positive ways. As the industry’s digital maturity rises, we are starting to see the benefits of greater connection. We will describe different use cases for connected devices in Bioprocess and Cell Therapy. Further, we will discuss how insights are generated and how digital twins will help us to run more stable processes.


Raw material information is used to predict the quality of filter production batches. Similarly, we build digital twins to predict product quality of biologicals production runs using raw material information from cell culture media production.

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.
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
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
8:50am - 9:15am 25 mins
Info
Analytical & Quality
Analytical Lifecycle Management Program to Support Commercial Processes
  • Debora Aguiar - Director, Specialty Care Quality, Sanofi Genzyme

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.

9:15am - 9:45am 30 mins
Info
Presentations 2
Capacity and beyond: Evaluation of a next generation protein A resin
  • Engin Ayturk, PhD - Senior Manager, Biogen

Protein A chromatography, an affinity-based purification method that selectively binds antibodies, is generally considered as one of the most expensive steps in a downstream process due to the high cost of protein A resin.  Decreasing the effective cost of the protein A step can be accomplished by increasing the amount of antibody that is processed per column cycle, either by increasing resin capacity or enhancing resin utilization through processing strategies such as continuous chromatography. Additionally, increasing the number of times a column is cycled can drive down the protein A cost per batch.

Here, we discuss the evaluation of a next generation protein A resin (MabSelect PrismA) with increased capacity and base-stability relative to other commercially available resins.  Dynamic binding capacity and purification performance at different loads were determined for several monoclonal antibodies on both a current generation protein A resin (MabSelect SuRe LX) and MabSelect PrismA. The impact of increased column loading on elution peak width and eluate pool pH were further investigated.  Cycling studies with representative cell culture material were also planned to assess whether increased resin lifetime could be achieved with MabSelect PrismA by utilizing a more stringent cleaning approach. Finally, an evaluation of continuous processing productivity was performed to maximize productivity and yield, while maintaining comparable product quality to batch purification. The results from the aforementioned studies provide evidence for a benefit of implementing MabSelect PrismA, through cost and productivity analyses for different processing scenarios

9:15am - 9:45am 30 mins
Info
Presentations 3
Bioproduction Efficiencies Gained Using the New ExpiCHO Stable Production Medium
  • Shreya Lowmaster, MSc - Field Application Scientist, Thermo Fisher Scientific

Transition from the transient to stable production workflow exclusively in CHO cells with the new Gibco™ ExpiCHO™ Stable Production Medium and cGMP banked Gibco™ ExpiCHO-S™ cells. Transient titers in shake flasks and stable clone titers in a 50L Thermo Scientific™ HyPerforma™ single-use bioreactor were greater than 3.0 g/L in a fed-batch process with comparable product quality.

9:15am - 9:45am 30 mins
Info
Presentations 4
Concurrent Scientific & Technology Presentations 4
  • Hans Johansson - Global Applications Director, Life Sciences, Purolite Life Sciences

The result of merging a novel technology for continuous emulsification of agarose beads, with a new alkaline stable Protein A ligand is presented.  The new Protein A resin has a dynamic binding capacity of more than 80 g mAb/l.  Application data includes pressure/flow properties, purification performance, and alkaline stability at 0.1 -1.0 M NaOH.

9:15am - 9:45am 30 mins
Info
Presentations 5
High-Throughput Screening techniques for Monoclonal Antibody Process to Expedite Development while Maximizing Product Quality and Yield
  • Darshini Shah - Scientist III, Patheon part of Thermo Fisher Scientific

Patheon’s HTS capability enhances unit-op and mitigates risk while expediting the timeline at a lower cost. This is demonstrated in the case studies: mAb A utilizes HTS to evaluate CEX resins for the conditions with the highest yield and product quality; mAb B screened affinity step to increase cleanability and HCP removal. Additionally, HTS is utilized for augmenting CEX DoE data

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)
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
10:30am - 11:00am 30 mins
Recovery & Purification
Characterizing and Optimizing Depth Filtration of a Therapeutic Protein
  • Jessica Kenney - Development Associate III, Alexion Pharmaceuticals
10:30am - 11:00am 30 mins
Info
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

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
Info
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

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
Info
Novel Technology Showcase- Single- Use Technologies
Assuring sterility of genderless sterile connectors from manufacturing to point of use - a Quality by Design (QbD) approach
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
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
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
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
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
11:00am - 11:30am 30 mins
Info
Novel Technology Showcase- Single- Use Technologies
Standardization of single-use systems: a case study for an end-to-end process solution
  • Richard Bhella, BSc - Sr. Manager, Applications & Technical Services, Pall Corporation

The customizability of single-use systems can be a double-edged sword. Being able to “have it your way” is appealing, but higher costs, longer lead times and inventory management challenges are common concerns with custom designs. In this session, we present a case study illustrating how a more standardized approach can offer significant cost and time savings without compromising process performance.

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
11:35am - 12:05pm 30 mins
Info
Workshop
An interactive workshop on advancing medium development for protein therapeutics.
  • Christopher Brau - R&D Engineer Scientist, Thermo Fisher Scientific

Cell culture media development methods have evolved from shotgun approaches to statistical designs in response to a rapidly growing biotherapeutic market.  To reach increasing titer goals and meet specific product quality profiles requires characterization of cellular function through omics and other knowledge building efforts.  This will be an interactive discussion on advances and challenges in medium development, selection and processes.

11:35am - 12:05pm 30 mins
Info
Workshop 2
How to use analytical tool for ADC process development
  • Marie Zhu - CEO of MabPlex US, MabPlex

Process development plays a key role in drug development. Robust process defines product quality and manufacturing consistency. A case study is presented here to demonstrate how the process parameters are defined based on analytical results.

11:35am - 12:05pm 30 mins
Info
Workshop 3
Application of Prior Knowledge Assessments to Facilitate End User Virus Filter Validation
  • Morven McAlister, Ph.D. - Senior Director, Pall Biotech

Virus filtration is a critical component of the virus clearance strategy for biopharmaceutical applications. We verify our virus filter design space studies can be used to facilitate prior knowledge assessments, by comparison to end user filterability and virus validation data across ranges of fluid properties and process parameters, such as pH, operating pressure and process interruptions.

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
Speed from Gene to Market
Chairperson's Remarks
  • Nikki Nogal, PhD - Senior Consultant, Biologics Product Development Specialist, Latham BioPharm Group
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
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
  • Agata Villiger-Oberbek, PhD - Senior Scientist, Codiak BioSciences
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.
1:30pm - 1:50pm 20 mins
Recovery & Purification
Chromatography-Free Capture of Antibodies
  • Kelli Luginbuhl, PhD - Chief Scientific Officer, Isolere Bio, Inc
1:30pm - 2:00pm 30 mins
Info
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

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 .

1:50pm - 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
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
2:00pm - 2:30pm 30 mins
Speed from Gene to Market
Fast-Track Process Development, Technology Transfer and Scale-Up Support of Speed to Market
  • Sourav Kundu, PhD - Senior Director, Teva Pharmaceuticals
2:00pm - 2:30pm 30 mins
Info
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


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.

2:10pm - 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
2:30pm - 3:00pm 30 mins
Cell Culture & Upstream Processing
Optimization and Implementation of a Protein-Free, Chemically-Defined Feed Medium for mAb Production
  • Garret Kasler - Research Associate, Biologics Process Development, Gilead Sciences, Inc.
2:30pm - 3:00pm 30 mins
Speed from Gene to Market
Understanding the Path from Process Characterization to Process Validation Completion- Dealing with Orphan and Fast Track Molecules
  • Greg Sears - Global Director of Process Validation, Manufacturing Sciences and Technology, Patheon, part of ThermoFisher Scientific
2:30pm - 2:50pm 20 mins
Recovery & Purification
Harvest Technologies Using Acoustic Wave Separation
  • Steven Wudyka - Senior Process Engineer, Momenta Pharmaceuticals
2:30pm - 3:00pm 30 mins
Bioprocessing 4.0: Smart Manufacturing
Design and Implementation of Fully Automated Biomanufacturing Unit Operations
  • Richard Braatz, PhD - Edwin R. Gilliland Professor, Faculty Research Officer, MIT
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

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

Networking Luncheon in the Poster & Exhibit Hall

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

Close of BPI 2018

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