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