Introduction to Bioassays and Bioanalytical Methods
- What is a potency assay?
- Product analytics versus Bioanalytics (preclinical & clinical approach)
- Why do we need bioassays?
- Characterisation of Biopharmaceuticals & Biosimilars
Regulatory Expectations and Requirements on Bioassays and Bioanalytical Methods
- Introduction and general aspects
- Bioassays and methods – expected data
- Guidance documents
GMP & G(C)(L)P Guidelines (EMA & FDA)
- Overview and Interpretation
Development of Bioactivity / Potency Assays – selecting Methods and Types of Assays
- Assay Types
- Feasibility
- Preparing the Cell Bank
- Optimization Parameters
- Replacement methods for primary assays
- Readouts
Development of Immunoassays for GCLP Bioanalytics
- Standards and controls
- Eliminating edge and hook effects
- Setting system suitability criteria
Strategies and Techniques to Improve Assays
- Improve accuracy and repeatability
- Avoid common technical errors
Statistical Analyses & Trending
Development of clinical Assays (PK/PD/ADA)
GMP Validation of Bioactivity (Potency) Assays
- Guidelines and Requirements
- Validation Parameters
- Setting Realistic Sample Specs for Validation
- Phase Specific Validation
- Validation Report
DOE
Case Studies on Special Bioassays for Biopharmaceuticals and Biosimilars
Method Transfer
- How to transfer a method?
- Transfer tools during product development
- Donor and Acceptor
- Investigation, calculation and comparison of method parameters
Live Online Training: Stability Testing for Biological/Biotechnological Drug Substances and Drug ProductsStability Testing of Biological and Biotechnological Drug Substances and Drug Products - Biologicals and relevant guidelines
- Specific differences between chemical entities and biologicals
- Stability-indicating profile of Monoclonal Antibodies and Immunoglobulins
- Storage conditions
- Impact of changes on stability
- Submitting stability data within the CTD-structure
Stability Studies and shelf-life Determination, starting Activities and Study Report
- Prerequisites for performing a stab study
- Concepts for study design and reporting
- Start, study performance and study closing
- Regulatory aspects during product development
- Objectives for a final stab study report
Stability Studies beyond Lot Stability
- Selection of appropriate, sensitive methods
- Analysis of stressed samples
- Statistical interpretation of shifts and drifts
- Acceptance limits
Study Design, Impurities and Stability Specifications
Degradation of Polysorbate
- Mechanisms of Polysorbate degradation
- Consequences of Polysorbate degradation
- Analytical tool box for degradation assessment
Stability Requirements of the new Guideline on Quality Documentation Concerning Biological Investigational Medicinal Products in Clinical Trials
- Control of excipients
- Specifications, batch analysis
- Stability data
- Shelf-life Determination
- Post approval Extension
- Substantial amendments