meet the training leaders
for complex therapeutics such as Biopharmaceuticals, Biologics & Biosimilars
All sessions of this unique course online
Live interaction options between the delegates and trainer
Available via mobile, tablet or laptop
Reveal the full schedule of the training as well as key topics, course objectives, key takeaways, special features, and the trainer bio!
Introduction to Bioassays, Binding Assays and Bioanalytical Methods
Bioassays & Binding Assays - regulatory updates
Bioassay development & qualification strategies
Characterization of biotherapeutics: requirements and challenges
Biostatistics for Bioanalytical Data Evaluation
Biological Assay Validation, Preparation & Performance
Bioassays for Immunogenicity testing & ADA analysis
Principles and development of GCLP Bioanalytics
Bioassays for characterization of monoclonal antibodies
Case studies: Selected bioassays under characterization & control
Understand
• The need for characterization of Biopharmaceuticals, Biologics & Biosimilars
• Bioanalytical method development (feasibility), optimization, qualification & final method validation or verification
• Biostatistics for bioanalytical data evaluation, calculation & release
Learn
• About EMA & FDA Bioassays & Bioanalytical Regulatory Updates
• How to characterize potency or strength of a biopharmaceutical drug
• How to design a bioassay validation protocol or report
• About analysis of dedicated drugs in complex matrices
Gain
• Principles and development of GCLP Bioanalytics
• Practical approach to biological assay validation
• Insight into a DOE for a Bioassay
