Online Vaccine Production Academy – Module 5 Batch Release

Short description

Module 5 of the Online Vaccine Production Academy will cover the batch release of a produced vaccine and covers the following topics:

• API/drug substance/drug product testing techniques, such as

- ELISA (for example host cell protein)
- QPCR (for example potency, titer, viral impurities, host cell DNA)
- HPLC
- Electrophoresis (SDS-page)
- Titer (TCID50)
- Flow cytometry
- Cell based
- Microbial

• National batch release (OMCL, OCABR)

All of the modules will be presented in a particularly interactive way. So not just listening, but active participation is encouraged and facilitated. Where possible, movies, quizzes, polls and live demonstrations of production steps in the cleanrooms of Biotech Training Facility are incorporated. Regulatory requirements will also be taken into account within the different modules.

In addition, there will be ample time to ask questions during the live Q&A sessions of each module. 

Objectives

After following Module 5, you have gained knowledge on:

• The different testing techniques for testing of drug substance and drug product and what exactly is being tested with these techniques
• What is an Official Control Authority Batch Release (OCABR) procedure and why is it implemented
• What is an Official Medicines Control Laboratories (OMCLs) and what is the role in release of a vaccine batch

Target group

Everyone who is interested to learn about different vaccine production and all that it entails. 

At least relevant for but not limited to:

• Employees of QA, QC, Manufacturing, R&D
• GMP Inspectors
• Dossier Assessors
• Consultants