Download Brochure - Well Characterized Biologics & Biological Assays

ENSURE CMC, REGULATORY SUCCESS AND EXPEDITED PRODUCT APPROVAL BY STREAMLINING AND OPTIMIZING CHARACTERIZATION, QUALITY AND ROBUST ASSAY DEVELOPMENT

Gain Practical Advice From Case Studies, FDA & Regulatory Leaders to Accelerate Your Biologics & Novel Modalities/Molecules to Market

October 27-29, 2020

Well Characterized Biologics & Biological Assays

Now part of BioProcess International!

September 18-21,2023
Boston Convention and Exhibition Center

Download the Full Agenda

for Well Characterized Biologics & Biological Assays 2023

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Well Characterized is now Part of BioProcess International

Well Characterized Biologics & Biological Assays Topics:

Emerging Trends in Characterization of Impurity and Degradant Peaks
Standards for Analytical Methods
Implementing Total Analytical Control Strategies
How to Properly Leverage Platform Technologies and Prior Knowledge for Successful QbD and Regulatory Approaches
Biological Assay Development
Biological Assays for Novel Modalities
Strategies for Accelerated Characterization, Method Development, and Method Transfers
Phase Appropriate Method Validation (Include Coverage of ICH Q2 and ICH Q14)
Analytical Challenges and Considerations for Formulations and Drug Product
Analytical and Regulatory Strategies for Biosimilars
Regulatory Perspectives on Emerging Trends, Global Harmonization, Interacting with FDA and Accelerated Pathway Designations
Regulatory Perspectives for Cell and Gene Therapies
Analytical strategies, CMC Approaches and Analytical Tools for Modern Vaccines, LNPs and Well Characterized Gene Therapies

Analytical & Quality Topics:

Advances in HTPD, Automation, and PAT that are Transforming the Bioprocessing Industry
Utilizing Mass Spectroscopy and Raman Spectroscopy in Process Development
Implementing Total Analytical Control Strategies
Advanced Analytics that Enable Continuous Processing
Achieving Real-Time Monitoring and Release
Risk Assessments for Maintaining Process & Product Quality Standards for Analytical Methods
Phase Appropriate Analytical Testing to Streamline the Product to Market New Multi-Attribute Methods Being Implemented in a QC Environment
Emerging Analytics for Host Cell Proteins
Analytical Methods for Novel Modalities and Biosimilars
Implementing Analytical Lifecycle Management Strategies