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 & Bioanalytical Methods
Bioassays & Binding Assays - regulatory & quality updates
Bioassay development, qualification & validation 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 - characterization & control
Understand
• Need for characterization of Biopharmaceuticals, Biologics & Biosimilars
• Bioanalytical method development – from 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 bioassay validation protocols or reports
• About analysis of dedicated drugs in complex matrices
Gain
• Principles & development of GCLP-Bioanalytics
• Practical approach to biological assay development & validation
• Insight into a DOE for a Bioassay
• Development strategies for bioassays dedicated to product specifications
