Informa Life Sciences is part of the Knowledge and Networking Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 3099067.

Informa
Sep 04
Show Filter
12:00pm - 1:00pm

Pre-Conference Symposia Registration

Showing of Streams
Showing of Streams
12:00pm - 1:00pm 60 mins
Pre-Conference Symposia Registration
1:00pm - 6:00pm 300 mins
Cell Line Development & Engineering
Cell Line Development Symposium Overview
more

Cell line development is critical to maximizing efficiency and quality in early stage development and increasing speed to IND.This symposium gathers the industry’s leading experts to explore the best approaches to assuring clonality, the latest applications of CRISPR and engineering techniques to boost quality and productivity, and utilizing next generation tools for cell line development. Case studies will cover the translation of big data to enhance cell line selection and host cell engineering, as well as theapplication of automation for cell line screening and clone selection.In addition, strategies for cell lines for emerging modalities will be discussed.

1:00pm - 6:00pm 300 mins
New Technologies for Viral Inactivation/Clearance
New Technologies for Viral Inactivation/Clearance Symposium Overview
more

This symposium will showcase novel technologies that companies are implementing along with evolving approaches to effectively achieve viral inactivation/clearance. Case studies with new data will share results, challenges, and lessons learned on the design and performance of viral clearance studies, in-depth evaluation of filtration and chromatography steps at various stages of development, and considerations for emerging modalities.

1:00pm - 5:00pm 240 mins
Continuous Bioprocessing
Continuous Processing Symposium Overview
  • Paul Langevin - Associate Director, Amicus Therapeutics
  • Wenqin He, PhD - Bioprocess Development Scientist, Continuous Manufacturing Skill Center, Sanofi Genzyme
  • Michael Felo - Director, Downstream Process Integration, MilliporeSigma
more

This symposium will provide a comprehensive discussion about the implementation of continuous processing throughout the biomanufacturing lifecycle. From upstream development to downstream development and the interface between the two, this symposium will provide an overview of the various unit operations in which continuous processing is currently being implemented, as well as the challenges of implementation. A review of enabling technologies and lessons learned, along with implementation case studies will be presented.

1:00pm - 1:15pm 15 mins
PAT in Biologics and Advanced Process Controls
Chairperson’s Remarks and Short Presentation: Managing Biologics Process Analytical Technology in Pfizer
  • Keith Davis - Principle Scientist, Analytical R&D, Pfizer
more

Coordinating PAT between development and manufacturing organizations is always challenging. When there are multiple development sites and numerous manufacturing sites, this becomes especially challenging. In order to help manage this in an efficient manner, we have established a PAT SME network with representation from the Manufacturing and the Development organizations. I will briefly introduce how this team facilitates PAT activities and attempts to add value to both organizations.

1:00pm - 2:00pm 60 mins
Process Intensification & Connected Processing
The Transformation to Excellence - How to Leverage Lean Principles to Improve Single-Use Assembly Product Quality and Supply Security
  • William Faria - Head of Danvers Operations Sara Bell, Senior Marketing Manager, Single-Use Solutions, Millipore Sigma
more
1:00pm - 1:30pm 30 mins
Process Development and Manufacturing Scale Up for Engineered Tissues
Panel Discussion – Title TBD
1:00pm - 1:15pm 15 mins
Raw Materials
Chairperson's Opening Remarks
1:15pm - 3:15pm 120 mins
Raw Materials
Session One
  • Omer Butt - Director, CMC Regulatory Affairs, Athersys, Inc, USA
more
1:30pm - 2:00pm 30 mins
Process Development and Manufacturing Scale Up for Engineered Tissues
Cost Considerations in Scaling up Adherent Cell Culture
1:45pm - 2:15pm 30 mins
PAT in Biologics and Advanced Process Controls
Advanced Process Analytics and Predictive Modelling for Process Performance Monitoring and Control
  • Julian Morris - Technical Director, University of Strathcylde
more

The presentation will address the analytical and production and quality assurance challenges, Quality and will set the scene through a series of highlighted themes: (i) pharmaceuticals development and production - a Systems view; (ii) challenges for data analytics and informatics systems and the impact of process and product variability, "where is the Variability, the cost of variability and impact on quality"; calibration maintenance and transfer, with case studies highlighting coping with multiplexed instruments, different probes and temperature-disturbed spectra using UV spectroscopy; calibration transfer between Lab and production plant; predictive modelling in fermentation scale-up; and the use of software / virtual sensors (Predictive Analytics) as an opportunity for Bio-processing.

2:00pm - 2:30pm 30 mins
Process Development and Manufacturing Scale Up for Engineered Tissues
Automation and Robotics in Large-Scale Engineered Tissue Manufacturing
2:15pm - 2:45pm 30 mins
PAT in Biologics and Advanced Process Controls
Real Time Online Chromatography Monitoring of Product Quality Attributes for Biologics Continuous Manufacturing Process
  • Gang Xue - Scientific Director, Process Analytics, Amgen
more
2:30pm - 3:00pm 30 mins
Process Development and Manufacturing Scale Up for Engineered Tissues
Integrated, Closed System PAT Analytics for Advanced Auto Feedback Control of CPPs in Single Use Bioreactors – Reactive Analytics
2:45pm - 3:15pm 30 mins
PAT in Biologics and Advanced Process Controls
Mapping Future Technology Needs for Real Time Release Testing
  • Udayanath Aich, Ph.D. - Principal Scientist, Bioanalytics, Sanofi-Genzyme
more

Real time monitoring and in-time release of products create a demand to move testing from QC release (off-line) analysis to the manufacturing shop floor (in-line, on-line or at-line monitoring), in order to address Biopharmaceutical manufacturing goals of reducing speed, cost and maximizing quality of product. BioPhorum Operations Group (BPOG) published a Biomanufacturing Technology Roadmap in July 2017 with the active collaboration of Biopharma industry representatives and supply partners. As part of implementation of roadmap strategy, BPOG’s ILM-RTR technical forum team is developing User Requirement Specifications (URS) for prioritized CQA’s and CPP focusing on the critical control points and future requirements of real time release (RTR). The URS documents will promote effective development of desired Short, Mid and Long term technologies by the innovators and supply partners.

3:00pm - 3:30pm 30 mins
Process Development and Manufacturing Scale Up for Engineered Tissues
Afternoon Coffee Break
3:15pm - 3:45pm 30 mins
PAT in Biologics and Advanced Process Controls
Networking Refreshment Break
3:15pm - 3:45pm 30 mins
Raw Materials
Afternoon Coffee Break
3:30pm - 4:00pm 30 mins
Process Development and Manufacturing Scale Up for Engineered Tissues
Role of Data Management and Artificial Intelligence in Automation of Biomanufacturing Process Development
3:45pm - 4:15pm 30 mins
PAT in Biologics and Advanced Process Controls
Inline Amidite Identification Using FTIR For Antisense Oligonuclueotide (ASO) Manufacturing
  • Elliott Schmitt, PhD - Scientist II, Analytical Development, Biogen
more

Nucleotide phosphoramidites (amidites) are used as building blocks during antisense oligonucleotide (ASO) synthesis. Synthesis of ASO drug substance is performed by flowing the correct sequence of amidite solution through the synthesis column one amidite at a time. Identification of the incoming amidite solution is required to confirm the synthetic sequence in real time and to quickly notify operators of non-conformance if one occurs. This work presents a method for identifying starting material amidites for ASO drug substance manufacturing. The method utilizes Fourier transform infrared spectroscopy combined with multivariate classification method for online identification. PLS-DA was implemented to successfully classify different amidite solutions prior to entering the synthesis column. Discussion will present this method as a platform technology solution for quality control of antisense oligonucleotide manufacturing for pharmaceutical industry.

3:45pm - 5:50pm 125 mins
Raw Materials
Session Two
  • Mithu Majumder - Project Manager, RoosterBio Inc., USA
more
4:00pm - 4:30pm 30 mins
Process Development and Manufacturing Scale Up for Engineered Tissues
Multi-platform-based characterization of cell and tissue processes: Application of DOE and QbD principles
4:15pm - 4:45pm 30 mins
PAT in Biologics and Advanced Process Controls
Integrating Raman Spectroscopy in the Manufacturing of Biotherapeutics
  • Peter Slade - Senior Principal Scientist, Bioprocess R&D, Pfizer
more

Chemometric models were developed to quantitate in real-time both glucose and lactate concentrations during IgG manufacturing. A feedback loop was developed, in which glucose and lactate concentrations were used to control glucose feeds. High-lactate process conditions were run with this two factor feedback control, results demonstrated that a culture could be shifted from lactate production to lactate consumption. For downstream processing, Raman spectroscopy was integrated into a continuous manufacturing skid. Models were developed to accurately measure titer at various points in the purification process.

4:30pm - 5:00pm 30 mins
Process Development and Manufacturing Scale Up for Engineered Tissues
What CBER wants to see in the development of a robust, scalable manufacturing process for engineered tissues
4:45pm - 5:15pm 30 mins
PAT in Biologics and Advanced Process Controls
Late Breaking Presentation
5:00pm - 5:30pm 30 mins
Process Development and Manufacturing Scale Up for Engineered Tissues
Keynote Address – Engineered Tissue Manufacturing: The Failures of the Past are the Lessons for Today
5:15pm - 5:45pm 30 mins
PAT in Biologics and Advanced Process Controls
PANEL DISCUSSION: Control Strategies and PAT Implementation in Biomanufacturing
  • Jeff Doyle - Manager, PAT Projects, Pfizer
  • Myra Coufal, PhD - Principal Scientist, Process Analytics, Digital Integration and Predictive Technologies, Amgen
  • Rob Guenard, PhD - Senior Director, Global Manufacturing Science, Biogen
more
5:30pm - 5:45pm 15 mins
Process Development and Manufacturing Scale Up for Engineered Tissues
Chairperson's Opening Remarks
5:50pm - 6:00pm 10 mins
Raw Materials
Chairperson's Closing Remarks and Look Ahead
6:00pm - 7:00pm 60 mins
Main Conference
Drinks Reception
6:00pm - 8:00pm 120 mins
An Evening of Diversity and Inclusion
PANEL DISCUSSION: Lead the Way: How to Champion Diversity and Inclusion in Life Sciences
more

We all agree that diversity and inclusion is an integral part of a successful organization’s culture. What can you do to make sure that diversity of race, gender, sexual orientation, backgrounds and perspectives is part of your company’s DNA? Hear from industry executives who are leading the way by implementing diversity and inclusion programs at their companies and organizations. Panelists will discuss what it takes to be a leader that drives diversity throughout an organization, and other actionable takeaways to get conversations about inclusion moving throughout your organization.


Roundtable Reception

Following the panel, join attendees for cocktails and conversation at an interactive networking reception. Members of the life science community who are forging the path for diversity will lead roundtable discussions throughout the room. Meet a potential mentor, connect with other attendees, and have substantive conversations about diversity and inclusion.


For more details please visit https://lifesciences.knect365.com/diversity-inclusion/

*Separate Registration Required. Cost to attend is $55 until July 31st, $65 until August 31st, and $75 thereafter. You may add this to your package during the online registration or by emailing register@knect365.com.