IBC Life Sciences and the Scientific Advisory Committees are currently accepting speaker proposals for Well Characterized Biologicals. If you are working in any of the following scientific/business topic areas, you are invited to submit a proposal for a podium presentation by the deadline of Friday, April 13, 2012.

Please consider submitting an abstract using the form below in one of the following topic areas:

CMC Strategies for Biosimilars

• How to enable biosimilars from a CMC perspective?
• Comparability and similarity
• FDA perspectives on biosimilar pathways
• What technologies and development strategies are needed?
• How can technologies like NMR be used to address the issue of biosimilarity?
• QC challenges in comparability of biosimilars

Comparability Strategies

• Learnings from the Genzyme's glycosylation issue - the impact of biochemical changes during a product run
• Non-confidential examples of comparability though development and post-approval: industry and regulatory perspectives
• Higher order structure as a method to test for comparability - does lot A look like lot B?
• Potency assays as an indirect way of understanding higher order structure
• Comparability for different manufacturing processes and manufacturing changes
• FDA expectations for comparability between pre-clinical/tox material and Phase 1
• Comparability of innovative products vs. biosimilars

Case Studies of Well Characterized Biologicals

• Complex molecules, ADCs, cell therapies and vaccines
• Characterization of proteins at high concentrations and in serum
• Phase 3 characterization requirements
• Glycan analysis and new techniques
• Immunogenicity prediction in the clinic: will analytical methods predict this?
• QbD approaches
• Structure-function studies
• Validation of methods to characterize higher order structure and correlation with CQA's
• Stability testing and forced degradation studies
• CMC Strategies in Early Development - cells, cloning, etc.
• Data to support CQA assessments (platform knowledge, preclinical and clinical studies, endogenous protein modifications)

Characterization and Comparability of Vaccines and Protein Products

• Strategies to assess biological potency
• Complex vaccine conjugates and glyco-conjugate vaccine analysis
• Analysis during downstream/upstream development
• FDA position on safety for vaccines
• Comparability strategies

CMC Strategies for Complex Products and Combination Products

• Large molecule and small molecule combinations
• Combinations of investigational agents
• Drug-diagnostic co-development projects - how can CMC groups share ideas with diagnostics
• Characterization of antibodies that target cancer stem cells/stem cells
• Characterization strategies for ADC's, complex conjugates, bispecifics, fusions
• Characterizing carbohydrates and carbohydrate analysis technology
• Characterization of therapeutic peptides and non mAb recombinant proteins
• Strategies for CMC studies for biosimilars in a compressed "quick to market" timeline
• Process residuals for biosimilars - host cell proteins, host cell DNA

Functional Biological Assays

• New approaches to develop functional assays
• Assays for cell therapy products, vaccines, mAbs and other proteins
• Qualification and validation of assays
• Potency assays

Assessment and Characterization of Aggregates, Particles and Impurities

• Strategies for mAb and non-mAb biological products
• Automation of Impurity testing (DNA, HCP, Protein A)
• Aggregate and subvisible particle analysis
• Regulatory perspectives on subvisible particulates
• Product impurities: PTM's, Glycosylation, etc.
• Process impurities: HCP's, Additives, PEG to purification, etc.
• Quantitation of visible protein aggregates in final container
• How to improve our limited understanding of different methods
• Developing protein aggregate mimicking standards
• Process residuals for biosimilars - host cell proteins, host cell DNA
• Satisfying FDA requests for semi-quantitative methods for visible particles
• Host cell protein assays - what have we learned from Omnitrope?

Biophysical Characterization Strategies

• Biophysical approaches to support comparability and characterization
• The role of CD, DSC, FTIR, Fluorescence in comparability studies
• Better analytical methods for biophysical characterization and higher-order structure of molecules to satisfy FDA requests

Regulatory Perspectives

• Regulatory perspectives on minor variations
• Regulatory perspectives on subvisible particulates
• FDA position on safety for vaccines
• Antibody-drug conjugates and other complex molecules
• Perspectives of EMEA and other regulatory bodies
• FDA perspectives on biosimilar pathways
• FDA expectations for comparability between pre-clinical/tox material and Phase 1

Emerging Technologies for Protein Characterization

• New analytical techniques
• New measurement science and technologies
• High-throughput in-process analytics
• Thermal methodology for bioprocessing and bioanalysis

Formulation Development

• Formulation troubleshooting and optimization
• High- and low- concentration/viscosity formulations
• Complex degradation pathways
• Validation of methodologies for complex formulations
• Visible and sub-visible particulates
• High-throughput screening for formulations
• Integrated formulation and purification development

Drug Product Delivery

• Non-standard delivery routes, including topical and aerosolized delivery
• Strategies for controlled release
• Novel delivery systems and devices

Integrated Formulation and Delivery

• Extended characterization to predict shelf-life
• Strategies for Integrated formulation and delivery
• Extractables and leachables and container closure integrity