IBC Life Sciences

Case Studies of Characterizing Biologicals

• Characterization strategies for recently approved molecules
• Process changes that worked/didn't work
• Post-approval issues that surfaced that were not found in clinical trials
• Characterizing Aggregates and aggregation pathways
• Applications of new technologies or new applications of older technologies
• Host cell impurities
• Process drift and comparability
• Beyond IgG1: Analytical profiles of IgG2, IgG3, IgG4, etc.

Characterizing Complex Protein Products

• Conjugate products
• Bispecific proteins
• Proteins as intermediates
• PEGylated molecules
• Fusion molecules

New Analytical Methods, Novel Expression Systems and Emerging Uses of Classical Technologies

• Effective tools for process analytics
• Regulatory perspectives on newer analytical technologies
• Novel expression systems: plant cell lines, etc.
• Bioprocess applications of TR FRET
• Measuring biophysical and chemical properties: in stability, etc.

Regulatory Perspectives

• Guidelines for extractables and leachables
• Specifications for and safety of raw materials
• Biophysical testing techniques and subvisible particulates
• Complex protein products - bispecifics, conjugates, combination products
• Impact of new technologies and low level heterogeneity
• Reprocessing and reworking/risk management
• Setting clinical stage and commercial characterization specifications
• Product quality versus product consistency
• Comparability guidances and an update on follow-on biologics
• Expectations for potency assays throughout the product lifecycle

Structure/Function and Critical Quality Attributes

• Glycosylation patterns
• Immunogenicity
• Disulfide and trisulfide scramblings
• in vitro and in vivo methods

Post-translational Modifications

• Developments in biochemical analysis
• Impact on product quality and function
• Strategies to support manufacturing and process change

Characterizing Protein Aggregation/Particulates/Subvisible Particles

• Novel methods and techniques to identify aggregates
• How to validate a new method for detecting/quantifying aggregates?
• Assays to characterize subvisible particles
• Link between analytics and subvisible particles
• The role of immunogenicity
• Characterizing biologicals for aggregates: how to handle the data

Biological Characterization of Immunogenicity

• The link between protein aggregation, particles and immunogenicity
• Immunogenicity of mixtures
• Risk assessment modeling and immunogenicity

Characterization Approaches to Formulations Development

• Formulations to address disulfides/trisulfides
• Formulations with closure
• Stability indication assays that involves direct interaction with analytical

Biosimilars

• FDA perspectives
• Clinical testing requirements
• Case studies of approved or emerging follow-on biologics
• Characterization and comparability: How similar is similar?

Other Considerations for Well Characterized Biologicals

• Selecting the right molecule and/or appropriate cell line with the right analytical profile at an early stage
• High-throughput cell line selection
• Defining critical quality attributes
• Global manufacturing/supply chain to ensure product quality and consistency

Co-Located Conference:

IBC's 1st Annual Real-Time and Online Process Monitoring and Process Analytics for Biologicals
For Process Scientists and Process Engineers
Tentative Dates: October 27-29, 2010 · Bethesda, MD
Shared Exhibit Hall with Well Characterized Biologicals Conference

Topics/Sessions:

• Improving sensor technologies and online analytical sensing technologies for biologics - sensors for disposables sensors and stainless steel bioreactors
• Online sampling systems for bioreactors to reduce lag time from testing in the lab to making process changes in the bioreactors
  • ph and potency assays for example
• Data anlaysis technologies to develop multivariant models to analyze all the data and then make process changes
• Interplay between analytical feedback and process design - how can analytical chemists and process scientists/engineers work better together?
• Testing methods for in-process analysis, process control and monitoring
• Case studies from biopharmas of concrete applications/implementations of real-time online process monitoring
• Emerging tools
  • Rapid microbiology for QC
  • New automated systems to characterize proteins for selection of target molecules
  • Rapid systems to introduce and optimize chromatographic purification and other protocols