Virus Filtration Process Development
and Validation: Best Practices
Two-day Course
Course Description
Through a mix of theory, a hands-on part and an interactive case study, participants will learn the key best practices and methods for virus filter sizing, optimization and validation preparation, enabling them to set up a cost-effective virus filtration process step.
Ordering Information: TRVIRFILT
Dates & Venue
Course Content
- Interpretation of the current regulatory environment
- Selecting the filter right for your product and selection criteria
- Virus filter optimization to achieve best operational and economical performance
- Increasing production efficiency and robustness
Learning Goals
- Develop a virus filtration process within a given process design space and regulatory framework.
- Identify the key process parameters for optimum sizing and scale-up.
- Explain and use the Vmax mathematical model.
- Explain and mitigate virus validation artifacts.
Who should attend?
The course is designed for process development engineers, validation engineers and technical support groups.
What will you receive?
- A copy of the course materials.
- Protocol and results of laboratory sessions.
- A certificate of attendance.
Course Schedule and Program
Day 1: 8:30 - 17:00
- Course introduction and welcome
- Basic virology
- Virus safety of biopharmaceuticals, and regulatory
- Break
- Virus filtration introduction and sizing: best practices
- Lunch
- Practical session – Vmax filter sizing model: understanding
the data, examples, troubleshooting
Day 2: 8.30 - 12:00
- Virus filtration validation: best practices
- Break
- Points to consider for scale-up and QbD
Hands-on practical section
Selection and sizing of virus filtration trains using a Vmax model
Prerequisites
You should have a basic understanding of normal flow filtration and downstream processing.
Enrollment limited to 6 participants
Due to the hands-on nature of this course, enrollment is limited to 6. We recommend early booking to ensure a place.
Price
Please contact your local representative or email ilearn@merckgroup.com for a quote.