Sprecher
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
Zielsetzung
The course includes a general discussion of GMP, GLP and GCLP principles and how they apply to potency assays, limits tests, pharmacokinetics, pharmacodynamics and immunogenicity. Furthermore you will learn the principles of phase specific validation as they relate to potency Bioassays and limits tests. We will outline the industry guidelines on PK assays with an emphasis on the accuracy and precision expectations for biopharmaceuticals, including Incurred Sample Reanalysis. The immunogenicity section helps the participants understand important regulatory expectations by a systematic evaluation of critical portions of the EMA guidance. In addition you become acquainted with the specific challenges of transferring Bioassays between laboratories and you get a checklist to identify and overcome the hurdles in the process. Workshops on writing validation protocols provide hands-on experience to cover these pivotal documents. You will also hear case studies that add relevance to the lecture materials and provide a launch point for class discussion.
Hintergrund
The number of biopharmaceutical products is increasing in the clinic and in the market. Their excellent targeting ability is the result of a high complexity that cannot be measured by analytical tests alone. Therefore, the development process of all biopharmaceutical products requires non-analytical tests to fully evaluate their functionality and safety. Biopharmaceutical development is a multi-disciplinary effort that involves many professionals with diverse backgrounds. This course will help team members without the appropriate technical background by clarifying the timelines, requirements and significance of Bioassays-based testing. The types of methods that will be addressed are cell-based assays, immunoassays and molecular assays.
Zielgruppe
- Manufacturing process professionals
- QA/QC staff and regulatory personnel
- Clinical staff, pharmacologists and toxicologists
- Project Managers & outsourcing personnel
- Analytical chemists and biochemists
Programm
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
- Key regulatory guidelines and industry white papers
- Life cycle of biopharmaceuticals
- Risk assessment
- Assay types
- Feasibility
- Preparing the cell bank
- Optimization parameters
- Replacement methods for primary assays
- Readouts
- Standards and controls
- Eliminating edge and hook effects
- Setting system suitability criteria
- Choice of statistical models
- Defining and improving intermediate precision
- Process controls
- Guidelines and requirements
- Validation parameters
- Setting realistic sample specs for validation
- Phase specific validation
- Validation report
- PK and immunogenicity
- DOE versus OFAT
- Critical parameters: accuracy, sensitivity & precision
- Population cut-point and confirmatory assays
- Stability of positive controls in biological matrix
- Incurred sample re-analysis
- Improve accuracy and repeatability
- Avoid common technical errors
- How to transfer a method?
- Transfer tools during product development
- Donor and Acceptor
- Investigation, calculation and comparison of method parameters
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