Informa
9月04日
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12:00pm - 1:00pm 60 mins
Pre-Conference Symposia Registration
1:00pm - 6:00pm 300 mins
Cell Line Development & Engineering
Cell Line Development Sympsoium Overview
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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
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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 - 6:00pm 300 mins
Continuous Bioprocessing
Continuous Processing Symposium Overview
  • Paul Langevin - Associate Director, Amicus Therapeutics
  • Wenqin He - Bioprocess Development Scientist, Sanofi
  • George Weeden Jr. - Process Engineer III, Sanofi
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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
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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 - 1:15pm 15 mins
Process Development and Manufacturing Scale Up for Engineered Tissues
Chairperson's Opening Remarks
1:00pm - 1:15pm 15 mins
Raw Materials
Chairperson's Opening Remarks
1:15pm - 1:45pm 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
1:15pm - 3:15pm 120 mins
Raw Materials
Session One
  • Omer Butt - Director, CMC Regulatory Affairs, Athersys, Inc, USA
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  • Elimination of variations, especially in starting and raw materials/ ancillary materials and manual manufacturing steps
  • GMP-grade raw materials
  • Regulatory guidance surrounding raw materials -  USP Chapter <1043>, <92> and EMA's Ph. Eur. General Chapter 5.2.12
  • Automated systems linked to the removal of variation in raw materials
  • Developments in manufacturing augmenting a greater need for higher quality raw materials and customised raw materials
  • Assessment of origin and impurity profiles
  • Best practise for providing documented evidence of purity, potency, consistency and stability
  • Supplier agreements and ensuring sufficient supply chain for large scale commercial manufacturing
  • Analytical testing
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
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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.

1:45pm - 2:15pm 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
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
2:15pm - 2:45pm 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
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
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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.


2:45pm - 3:15pm 30 mins
Process Development and Manufacturing Scale Up for Engineered Tissues
Role of Data Management and Artificial Intelligence in Automation of Biomanufacturing Process Development
3:15pm - 3:45pm 30 mins
PAT in Biologics and Advanced Process Controls
Networking Refreshment Break
3:15pm - 3:45pm 30 mins
Process Development and Manufacturing Scale Up for Engineered Tissues
Afternoon Coffee Break
3:15pm - 3:45pm 30 mins
Raw Materials
Afternoon Coffee Break
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 - 4:15pm 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
3:45pm - 5:50pm 125 mins
Raw Materials
Session Two
  • Mithu Majumder - Project Manager, RoosterBio Inc., USA
more
  • Elimination of variations, especially in starting and raw materials/ ancillary materials and manual manufacturing steps
  • GMP-grade raw materials
  • Regulatory guidance surrounding raw materials -  USP Chapter <1043>, <92> and EMA's Ph. Eur. General Chapter 5.2.12
  • Automated systems linked to the removal of variation in raw materials
  • Developments in manufacturing augmenting a greater need for higher quality raw materials and customised raw materials
  • Assessment of origin and impurity profiles
  • Best practise for providing documented evidence of purity, potency, consistency and stability
  • Supplier agreements and ensuring sufficient supply chain for large scale commercial manufacturing
  • Analytical testing
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.


4:15pm - 4:45pm 30 mins
Process Development and Manufacturing Scale Up for Engineered Tissues
Automation and Robotics in Large-Scale Engineered Tissue Manufacturing
4:45pm - 5:15pm 30 mins
PAT in Biologics and Advanced Process Controls
Late Breaking Presentation
4:45pm - 5:15pm 30 mins
Process Development and Manufacturing Scale Up for Engineered Tissues
Cost Considerations in Scaling up Adherent Cell Culture
5:15pm - 6:00pm 45 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
5:15pm - 5:50pm 35 mins
Process Development and Manufacturing Scale Up for Engineered Tissues
Panel Discussion - Title TBD
5:50pm - 6:00pm 10 mins
Process Development and Manufacturing Scale Up for Engineered Tissues
Chairperson's Closing Remarks and Look Ahead
5:50pm - 6:00pm 10 mins
Raw Materials
Chairperson's Closing Remarks and Look Ahead
6:00pm - 7:00pm 60 mins
Drink's Reception
12:00pm - 1:00pm

Pre-Conference Symposia Registration

Showing of Streams
6:00pm - 7:00pm

Drink's Reception

* 活动内容有可能不事先告知作更动及调整。