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Mar 13
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7:15am - 8:00am

Technology Workshops with Light Continental Breakfast

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Showing of Streams
9:15am - 9:55am

Networking Refreshment Break and Grand Opening of the Exhibit & Poster Hall

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Showing of Streams
12:00pm - 1:10pm

Networking Luncheon in the Exhibit & Poster Hall

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

Final Refreshment Break in the Exhibit & Poster Hall

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Showing of Streams
5:30pm - 6:30pm

BPI West Offsite Party

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7:15am - 8:00am 45 mins
Technology Workshops with Light Continental Breakfast
8:00am - 8:05am 5 mins
Plenary Session
Chairperson’s Opening Remarks
8:05am - 9:15am 70 mins
Plenary Session
Digitalization
  • Rahul Singhvi - Chief Operating Officer, Takeda Vaccines, Inc
9:15am - 9:55am 40 mins
Networking Refreshment Break and Grand Opening of the Exhibit & Poster Hall
9:55am - 10:00am 5 mins
Flexible & Smart Facilities
Chairperson’s Opening Remarks
9:55am - 10:00am 5 mins
Early Stage Process Development
Chairperson’s Opening Remarks
9:55am - 10:00am 5 mins
Late Stage Process Development
Chairperson’s Opening Remarks
9:55am - 10:00am 5 mins
Commercial Manufacturing & Beyond
Chairperson’s Opening Remarks
9:55am - 10:00am 5 mins
Viral Safety
Chairperson’s Opening Remarks
9:55am - 10:00am 5 mins
Sponsorship Opportunity
Chairperson’s Opening Remarks
10:00am - 10:30am 30 mins
Early Stage Process Development
Early Stage Perfusion Process Development Of A mAb Using GS-CHO Cell Line
  • Rajesh Beri, Ph.D. - Technical Director R & T, BioManufacturing, Lonza
10:00am - 10:30am 30 mins
Late Stage Process Development
Early Stage Perfusion Process Development Of A mAb Using GS-CHO Cell Line
  • Rajesh Beri, Ph.D. - Technical Director R & T, BioManufacturing, Lonza
10:00am - 11:30am 90 mins
Viral Safety
Ask the Regulators – Regulatory Breakfast Briefing
  • Arifa Khan - Supervisory Microbiologist, FDA
10:30am - 11:00am 30 mins
Info
Flexible & Smart Facilities
Case Studies from the Pathway to Industry 4.0
  • Paul Hanson - Director, Technical Operations, Takeda Pharmaceuticals

The highly regulated environment of pharmaceutical and biopharmaceutical manufacturing represents a hurdle to realizing the promise of Industry 4.0 where data are leveraged to reduce supply chain and compliance risks for patients.  Case studies will be presented that highlight how machine learning, system integration and process simulation are being used by Takeda to realize patient focused benefits from Industry 4.0.

10:30am - 11:00am 30 mins
Info
Early Stage Process Development
Integrated Bioprocess from Harvest to Purified Bulk in 6 Hours
  • Ping Huang, PhD - Director, Abbvie

Antibody production platform process has been widely adapted in biotech industry, but many unit operations are complex and not suitable for integration and automation. This presentation describes our development work in recent years, including cell culture productivity improvement, product quality manipulation, buffer simplification and column format transformation. These development activities lead to a next generation integrated bioprocess that is continuous, personalized and automated, reducing processing time of harvest to purified bulk from approximately 2 weeks to 6 hours.

10:30am - 11:00am 30 mins
Info
Late Stage Process Development
Integrated Bioprocess from Harvest to Purified Bulk in 6 Hours
  • Ping Huang, PhD - Director, Abbvie

Antibody production platform process has been widely adapted in biotech industry, but many unit operations are complex and not suitable for integration and automation. This presentation describes our development work in recent years, including cell culture productivity improvement, product quality manipulation, buffer simplification and column format transformation. These development activities lead to a next generation integrated bioprocess that is continuous, personalized and automated, reducing processing time of harvest to purified bulk from approximately 2 weeks to 6 hours.

10:30am - 11:00am 30 mins
Info
Commercial Manufacturing & Beyond
Case Studies from the Pathway to Industry 4.0
  • Paul Hanson - Director, Technical Operations, Takeda Pharmaceuticals

The highly regulated environment of pharmaceutical and biopharmaceutical manufacturing represents a hurdle to realizing the promise of Industry 4.0 where data are leveraged to reduce supply chain and compliance risks for patients.  Case studies will be presented that highlight how machine learning, system integration and process simulation are being used by Takeda to realize patient focused benefits from Industry 4.0.

11:00am - 11:30am 30 mins
Flexible & Smart Facilities
Industry 4.0 and Continuous Biopharmaceutical Manufacturing
  • Samet Yildirim - Manager, Technology & Innovation, Global Technology Management, Boehringer Ingelheim Fremont, Inc.
11:00am - 11:30am 30 mins
Commercial Manufacturing & Beyond
Industry 4.0 and Continuous Biopharmaceutical Manufacturing
  • Samet Yildirim - Manager, Technology & Innovation, Global Technology Management, Boehringer Ingelheim Fremont, Inc.
11:30am - 12:00pm 30 mins
Flexible & Smart Facilities
Technology Workshop
11:30am - 12:00pm 30 mins
Early Stage Process Development
Technology Workshop
11:30am - 12:00pm 30 mins
Late Stage Process Development
Technology Workshop
11:30am - 12:00pm 30 mins
Commercial Manufacturing & Beyond
Technology Workshop
11:30am - 12:00pm 30 mins
Viral Safety
Technology Workshop
12:00pm - 1:10pm 70 mins
Networking Luncheon in the Exhibit & Poster Hall
1:10pm - 1:15pm 5 mins
Flexible & Smart Facilities
Chairperson’s Opening Remarks
1:10pm - 1:15pm 5 mins
Early Stage Process Development
Chairperson’s Opening Remarks
1:10pm - 1:15pm 5 mins
Late Stage Process Development
Chairperson’s Opening Remarks
1:10pm - 1:15pm 5 mins
Commercial Manufacturing & Beyond
Chairperson’s Opening Remarks
1:10pm - 1:15pm 5 mins
Viral Safety
Chairperson’s Opening Remarks
1:10pm - 1:15pm 5 mins
Sponsorship Opportunity
Chairperson’s Opening Remarks
1:15pm - 1:45pm 30 mins
Flexible & Smart Facilities
Online Cell Culture Titer/Capture Load Density Monitoring and Contro
  • Joe Sexton - Senior Technical Specialist, Genentech
1:15pm - 1:45pm 30 mins
Early Stage Process Development
Managing Process Characterization and Validation on a Breakthrough Therapy Program
  • Michael Glacken, Ph.D. - Senior Consultant, BioProcess Technology Consultants, Inc.
  • Joan Connolly - SVP, Technical Operations, Stemline Therapeutics, Inc.
1:15pm - 1:45pm 30 mins
Late Stage Process Development
Managing Process Characterization and Validation on a Breakthrough Therapy Program
  • Michael Glacken, Ph.D. - Senior Consultant, BioProcess Technology Consultants, Inc.
  • Joan Connolly - SVP, Technical Operations, Stemline Therapeutics, Inc.
1:15pm - 1:45pm 30 mins
Commercial Manufacturing & Beyond
Online Cell Culture Titer/Capture Load Density Monitoring and Contro
  • Joe Sexton - Senior Technical Specialist, Genentech
1:15pm - 1:45pm 30 mins
Viral Safety
Case Study: Next Generations Sequencing and Adventitious Virus detection
  • Cassandra Braxton - Senior Manager, Biogen
1:45pm - 2:15pm 30 mins
Early Stage Process Development
Translating Scale Down Models to Scale Up Success: Designing Predictive Scale Down Models
  • Parviz Shamlou - Professor, Director of Amgen Bioprocessing Center, Keck Graduate Institute
1:45pm - 2:15pm 30 mins
Late Stage Process Development
How Timeline Compression for Breakthrough Therapies Impact Characterization and Validation
  • Niket Bubna - Scientist, Cell Culture Process Development, KBI Biopharma
1:45pm - 2:15pm 30 mins
Viral Safety
2nd Generation Reference Materials for Adventitious Virus Detection by Deep Sequencing
  • Edward Mee - Senior Scientist, Live Viral Vaccines Group, National Institute for Biological Standards and Control
2:15pm - 2:45pm 30 mins
Info
Flexible & Smart Facilities
Real Time Process Analytics Implementation and Establishing Process Monitoring Programmes
  • Richard Wu, PhD - Principal Scientist, Amgen

It is an important and a desirable capability to be able to closely monitor and control the quality and quantity of any therapeutic product throughout its entire production period.  By beginning with the final product quality in mind, proposed strategy is to closely integrate process science with process model control to modulate critical quality attributes (CQAs).  It starts with defining CQAs of the therapeutic product and understands critically the process and attribute relationship (PAR). PAR provides biochemical mechanisms of how process parameters impact key CQAs and identifies levers that modulate CQAs to pre-determined levels. The process is then developed using product attribute control (PAC) which combines multiple process analytical technology (PAT) elements to enact real-time sampling, analytics and feedback control of one or multiple CQAs.  PAC implementation allows CQAs to be monitored and controlled (by levers) throughout the production process.  Based on the real time process inputs and CQA responses generated by PAC, an empirical-based model predictive control (MPC) for one or multiple CQAs can be created and applied.  This strategy, by combining PAR, PAC, and MPC, can further integrate with multivariate statistical process control (MSPC) to advance our understanding and control of the processes to deliver high quality therapeutics to our patients.

2:15pm - 2:45pm 30 mins
Info
Early Stage Process Development
Automation and Digitalization in Upstream Process Development: Embedding Advanced Microscale Bioreactors (ambr) In An Efficient Sample And Data Workflow
  • Timo Frensing - Senior Scientist, Large Molecule Research, Roche Diagnostics GmbH

High-throughput USP development can be supported by a combination of microscale bioreactors such as ambr® (Sartorius), efficient sample processing and analytics via a Fluent® pipetting robot (Tecan) and the Cedex Bio HT Analyzer (Roche Diagnostics), and last but not least an automated data processing that connects and integrates all devices.  

2:15pm - 2:45pm 30 mins
Late Stage Process Development
Approach to Determining CQAs
  • Zhimei Du, PhD - Director, Merck & Co
2:15pm - 2:45pm 30 mins
Info
Commercial Manufacturing & Beyond
Real Time Process Analytics Implementation and Establishing Process Monitoring Programmes
  • Richard Wu, PhD - Principal Scientist, Amgen

It is an important and a desirable capability to be able to closely monitor and control the quality and quantity of any therapeutic product throughout its entire production period.  By beginning with the final product quality in mind, proposed strategy is to closely integrate process science with process model control to modulate critical quality attributes (CQAs).  It starts with defining CQAs of the therapeutic product and understands critically the process and attribute relationship (PAR). PAR provides biochemical mechanisms of how process parameters impact key CQAs and identifies levers that modulate CQAs to pre-determined levels. The process is then developed using product attribute control (PAC) which combines multiple process analytical technology (PAT) elements to enact real-time sampling, analytics and feedback control of one or multiple CQAs.  PAC implementation allows CQAs to be monitored and controlled (by levers) throughout the production process.  Based on the real time process inputs and CQA responses generated by PAC, an empirical-based model predictive control (MPC) for one or multiple CQAs can be created and applied.  This strategy, by combining PAR, PAC, and MPC, can further integrate with multivariate statistical process control (MSPC) to advance our understanding and control of the processes to deliver high quality therapeutics to our patients.

2:15pm - 2:45pm 30 mins
Viral Safety
Plant-derived Raw Material Control for adventitious virus in cell banking and biologics productio
  • Serge Monpoeho - Director of Virology, Regeneron Pharmaceuticals
2:45pm - 3:15pm 30 mins
Flexible & Smart Facilities
Scientific Track Presentation
2:45pm - 3:15pm 30 mins
Early Stage Process Development
Scientific Track Presentation
2:45pm - 3:15pm 30 mins
Late Stage Process Development
Scientific Track Presentation
2:45pm - 3:15pm 30 mins
Commercial Manufacturing & Beyond
Scientific Track Presentation
2:45pm - 3:15pm 30 mins
Viral Safety
Scientific Track Presentation
3:15pm - 4:00pm 45 mins
Final Refreshment Break in the Exhibit & Poster Hall
4:00pm - 4:30pm 30 mins
Info
Flexible & Smart Facilities
DIY Digital Transformation, Design and Development
  • Thibault Dutronc - Associate Scientist, Merck Serono SA

Raspberry Pi, Arduino, 3D printing are the technologies of the DIY revolution. In the lab, they have the potential to drive innovation and creativity. This presentation will highlights the achievements and opportunities encountered in our development laboratory. From data acquisition, to sample tracking, automation, spare parts printing, multi-variate data analytics ... possibilities are endless.

4:00pm - 4:30pm 30 mins
Early Stage Process Development
Novel Cell Line Screening and Clone Selection Technologies for Faster, More Predictive Identification of High Quality Producer
  • Yang Ou, PhD - Post Doc Fellow, Merck & Co., Inc
4:00pm - 4:30pm 30 mins
Late Stage Process Development
A First-Principles Approach to Cleaning Validation: Rational Acceptance Limits for Biopharmaceutical Process Residues
  • Rizwan Sharnez, B. Tech., M.S., Ph.D. - Scientific Director, Process Development, Amgen Inc.
4:00pm - 4:30pm 30 mins
Commercial Manufacturing & Beyond
A First-Principles Approach to Cleaning Validation: Rational Acceptance Limits for Biopharmaceutical Process Residues
  • Rizwan Sharnez, B. Tech., M.S., Ph.D. - Scientific Director, Process Development, Amgen Inc.
4:00pm - 4:30pm 30 mins
Info
Viral Safety
DIY Digital Transformation, Design and Development
  • Thibault Dutronc - Associate Scientist, Merck Serono SA

Raspberry Pi, Arduino, 3D printing are the technologies of the DIY revolution. In the lab, they have the potential to drive innovation and creativity. This presentation will highlights the achievements and opportunities encountered in our development laboratory. From data acquisition, to sample tracking, automation, spare parts printing, multi-variate data analytics ... possibilities are endless.

4:30pm - 5:00pm 30 mins
Flexible & Smart Facilities
Big Data to Smart Data – Feedback from the BioPhorum Automated Facility Workstream
  • Bob Lenich - Life Sciences Business Director, Emerson Automation Solutions / BioPhorum Automated Facility Workstream
4:30pm - 5:00pm 30 mins
Early Stage Process Development
Assuring and Proving Monoclonality
4:30pm - 5:00pm 30 mins
Late Stage Process Development
How to Achieve Tech Transfer Goals?  What are the Timelines?  How to Overcome the Bottlenecks?
  • Padmadhar Madupu, MS - Technical Manager, Pfizer
4:30pm - 5:00pm 30 mins
Commercial Manufacturing & Beyond
How to Achieve Tech Transfer Goals?  What are the Timelines?  How to Overcome the Bottlenecks?
  • Padmadhar Madupu, MS - Technical Manager, Pfizer
4:30pm - 5:00pm 30 mins
Viral Safety
Big Data to Smart Data – Feedback from the BioPhorum Automated Facility Workstream
  • Bob Lenich - Life Sciences Business Director, Emerson Automation Solutions / BioPhorum Automated Facility Workstream
5:00pm - 5:30pm 30 mins
Info
Flexible & Smart Facilities
Thought Leaders Discussion: Strategies for Aligning Industry 4.0 and a Smart Manufacturing Vision with Biopharma
  • Smart Manufacturing Vision: What is needed to align industry 4.0 and smart manufacturing within the biopharmaceutical sector? 

  • Technologies and impact on manufacturing processes 

  • Sensor development to handle harsh chemical environments 

  • Connectivity: How to reduce waste by connecting all devices in manufacturing? 

  • New process platforms, increased intensity for different cell modalities 

  • Adapting batch originated biopharmaceutical manufacturing with smart manufacturing vision – Implementing continuous manufacturing for highly autonomous smart facility 

  • Applicability of robotics, automation and software platforms in biopharmaceutical manufacturing environment 

  • Designing feasible, fully operational smart product agonist facilities 

  • Digitalisation initiatives applied in biopharma for process intensification 

  • People and digital environment - Identifying the right workforce skill set required for digitalisation and where people are needed in automated field? 

  • How can 3D printing be part of disposable processes? 

  • Regulatory expectations and requirements for smart factories in the biopharmaceutical sector

5:00pm - 5:30pm 30 mins
Early Stage Process Development
New Tools and Technologies to Enhance Cell Line Development: A Case Study from Pfizer
5:00pm - 5:30pm 30 mins
Late Stage Process Development
Lessons from Back-to-Back Technology Transfers from an Established DS Manufacturing Production Site to a Non-Licensed Facility
  • Lisa Day - Engineer, Manufacturing Sciences, Genentech
5:00pm - 5:30pm 30 mins
Commercial Manufacturing & Beyond
Lessons from Back-to-Back Technology Transfers from an Established DS Manufacturing Production Site to a Non-Licensed Facility
  • Lisa Day - Engineer, Manufacturing Sciences, Genentech
5:00pm - 5:30pm 30 mins
Info
Viral Safety
Thought Leaders Discussion: Strategies for Aligning Industry 4.0 and a Smart Manufacturing Vision with Biopharma
  • Smart Manufacturing Vision: What is needed to align industry 4.0 and smart manufacturing within the biopharmaceutical sector? 

  • Technologies and impact on manufacturing processes 

  • Sensor development to handle harsh chemical environments 

  • Connectivity: How to reduce waste by connecting all devices in manufacturing? 

  • New process platforms, increased intensity for different cell modalities 

  • Adapting batch originated biopharmaceutical manufacturing with smart manufacturing vision – Implementing continuous manufacturing for highly autonomous smart facility 

  • Applicability of robotics, automation and software platforms in biopharmaceutical manufacturing environment 

  • Designing feasible, fully operational smart product agonist facilities 

  • Digitalisation initiatives applied in biopharma for process intensification 

  • People and digital environment - Identifying the right workforce skill set required for digitalisation and where people are needed in automated field? 

  • How can 3D printing be part of disposable processes? 

  • Regulatory expectations and requirements for smart factories in the biopharmaceutical sector

5:30pm - 6:30pm 60 mins
BPI West Offsite Party