Rainer Fedra, VelaLabs, Austria
Markus Fido, VelaLabs, Austria
Tino Galgon, IDT Biologika, Germany
Siegfried Giess, Paul Ehrlich Institute, Germany
Ulrike Herbrand, Charles River Laboratories, Germany
Manufacturing process professionals
QA/QC staff and regulatory personnel
Clinical staff, pharmacologists and toxicologists
Project Managers & outsourcing personnel
Analytical chemists and biochemists
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