Bioassays and Bioanalytics & Stability Testing of Biological and Biotechnological Drug Substances and Drug Products

Programme

Bioassays and Bioanalytics

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

GMP and G(C)(L)P Guidelines (EMA & FDA Overview and Interpretation

• Key regulatory guidelines and industry white papers
• Life cycle of biopharmaceuticals
• Risk assessment

Development I - Selecting Methods and Types of Assays

• Assay types
• Feasibility
• Preparing the cell bank
• Optimization parameters
• Replacement methods for primary assays
• Readouts

Development II – focus on clinical assays (PK/PD/ADA)

• Standards and controls
• Eliminating edge and hook effects
• Setting system suitability criteria

GMP Pre-Validation of Bioactivity (Potency) Assays

• Choice of statistical models
• Defining and improving intermediate precision
• Process controls

GMP Validation Protocol of Bioactivity (Potency) Assays

• Guidelines and requirements
• Validation parameters
• Setting realistic sample specs for validation
• Phase specific validation
• Validation report

Development of Immunoassays for GCLP Bioanalytics

• PK and immunogenicity
• DOE versus OFAT

GCLP Validation of Immunoassays with Focus on Bioanalytics

• Critical parameters: accuracy, sensitivity & precision
• Population cut-point and confirmatory assays
• Stability of positive controls in biological matrix
• Incurred sample re-analysis

Strategies and Techniques to improve Assays

• Improve accuracy and repeatability
• Avoid common technical errors

Method Transfer

• How to transfer a method?
• Transfer tools during product development
• Donor and Acceptor
• Investigation, calculation and comparison of method parameters

Stability Testing of Biological and Biotechnological Drug Substances and Drug Products

Stability 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

Optimising Packaging and Storage Conditions for Biotech Products

• Peculiarities of biotech products
• Transport/storage conditions:
• Planning of stability testing considering the supply chain
• Cost-benefit considerations
• Examples of stability studies
• Presentation and documentation of data
• Packaging
• Specific characteristics of packaging materials
• Photostability studies
• Transportation stress studies

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

Workshop I:
Study Design, Impurities and Stability Specifications

Workshop II:
Potency Assays