Bioassays and Bioanalytics
Copenhagen, Denmark
Course No 16681
Our Service
Costs
| Non-ECA Members: | EUR 1790,-- |
| ECA Members: | EUR 1590,-- |
| EU GMP Inspectorates: | EUR 895,-- |
| APIC Members (does not include ECA membership): | EUR 1690,-- |
(All prices excl. VAT)
If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org
Speakers
Rainer Fedra, VelaLabs, Austria
Markus Fido, VelaLabs, Austria
Siegfried Giess, form. Paul Ehrlich Institue, Germany
Ulrike Herbrand, Charles River Laboratories, Germany
Michael Leiss, Roche Diagnostics, Germany
Dr Manuela Leitner, AGES, Austria
Objectives
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.
Background
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.
Target Group
- Manufacturing process professionals
- QA/QC staff and regulatory personnel
- Clinical staff, pharmacologists and toxicologists
- Project Managers & outsourcing personnel
- Analytical chemists and biochemists
Programme
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
Development I - Selecting Methods and Types of Assays
- 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
1. Validation Protocol Workshop for Bioactivity (Potency) Bioassays
2. Validation Protocol Workshop for PK/PD and Immunogenicity Assays
Strategies and Techniques to improve Assays
- 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
GMP Conferences by Topics
- Quality Assurance
- GMP in Biotechnology
- Microbiology
- Regulatory Affairs
- GMP in Pharmaceutical Development
- Quality Control
- GDP
- Sterile / Aseptic Manufacturing
- Computer Validation
- Validation
- Technical Operations
- GMP for APIs and Excipients
- Medical Devices
- GMP Basic Training Courses
- Packaging
- Data Integrity