Summary
Biologics continue to be a steadily growing component of the pharmaceutical industry. Large molecule therapeutics requires a different perspective on the assays needed to support development through preclinical and clinical testing. This webinar is designed to offer both a broad overview and detailed discussion of specific issues to address when developing and validating PK and ADA assays for biologics. The course offers:
- Interactive, Real-World Applications: Practical troubleshooting sessions and real-world case studies to apply knowledge to current challenges.
- Emerging Trends: Coverage of the latest updates in regulatory guidance (e.g., M10) and innovations in bioanalytical methods.
- Advanced Techniques: Learn about cutting-edge technologies like BEAD (Biotin-Drug Extraction and Acid Dissociation) for resolving drug interference and electrochemiluminescence using MSD for assay sensitivity and efficiency.
Learning Objectives
- Understanding current regulatory expectations
- Designing, developing, optimizing, and validating key methods
- Preclinical method qualification/validation vs. clinical method validation
- Use of DOE and statistical analysis
- Handling of critical materials
- Process monitoring concepts
- Overcoming impact of the matrix and comedications
- Assessing readiness for validation
- Defining the validation protocol with real-time capture of data analysis
- Maintaining quality through documentation
- Identify potential challenges to ADA methods
- Practical consideration for development of positive controls
- Understanding the complexity of potential interference
- Gain knowledge of new technologies to overcome assay interference
- Implementing a strategy to overcome challenging methods
- Designing ADA methods for modified drugs
- Understanding and targeting domain specificity
Key Topics
- Regulatory Guidance
- PK Methods
- Immunogenicity Methods
- Troubleshooting Assay Failures
Who should attend?
Laboratory managers, Lead scientists, Development/analytical scientists, Validation scientists, Regulatory affairs professionals, Clinical scientists, Quality assurance specialists, Data scientists, Principal scientists, Senior scientists, Directors of clinical laboratories, Development scientists, Program directors
Our online training experience includes
- Our client zone – a single source for all training materials as well as pre and post-training communication
- Live interactive format via the Zoom platform
- Direct interaction with the trainer
- Q&As, case studies, polls
- Training in digital format
- Digital and LinkedIn certificates
Trainers
PK and ADA Assays for Biologics
Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.
