Objectives
Background
Target Group
- Manufacturing process professionals
- QA/QC staff and regulatory personnel
- Clinical staff, pharmacologists and toxicologists
- Project Managers & outsourcing personnel
- Analytical chemists and biochemists
Technical Requirements
For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.
At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
Programme

Seminar Programme as PDF
- What is a potency assay?
- Product analytics versus Bioanalytics (preclinical & clinical approach)
- Why do we need bioassays?
- Characterisation of Biopharmaceuticals & Biosimilars
- Introduction and general aspects
- Bioassays and methods – expected data
- Guidance documents
- Overview and Interpretation
- 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
- Improve accuracy and repeatability
- Avoid common technical errors
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 versus OFAT
- ADCC/CDC
- RBA mAb
- How to transfer a method?
- Transfer tools during product development
- Donor and Acceptor
- Investigation, calculation and comparison of method parameters
This course is part of the GMP Certification Programme "ECA Certified Quality Control Manager" Learn more
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Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org

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Seminar Programme as PDF