Provisional timetable, the actual schedule may vary depending on the situation
09.00 – 09.15 h Welcome and Organisational
09.15 – 10.00 h
GMP for Vaccines: What are the Issues?
- Differences between vaccines and conventional products
- Inactivated and live vaccines
- Control of vaccine strains and cell lines
- Risk of (cross-)contamination
- (Bio)safety issues
10.00 – 11.00 h
The Peculiarities of Viral Vaccines
- From viral seeds to finished products
- Requirements for raw and starting materials
- Efficient process and product control
- Setting specifications adequately
- Appropriate tests and assays for product release
- Stability testing
- Viral safety aspects
- TSE compliance
- How to deal with OOS results?
- Requirements for early and late clinical trial phases
11.00 – 11.15 h Break
11.15 – 12.30 h
The Peculiarities of Bacterial Vaccines
- Types of vaccines available
- Manufacturing of classical/modern bacterial vaccines
- Challenges in manufacturing (quality/regulatory issues)
- New technologies and products
12.30 – 13.00 h
Questions and Answers
13.00 -14.00 h Break
14.00 – 15.00 h
cGMP Issues for Upstream Processing
- General GMP concerns for upstream processing
- Raw materials and media preparation
- Cell culture
- Virus culture
- Inactivation of microorganisms
15.00 -15.45 h
Containment, Biological Safety and Product Protection
- Containment, product safety versus environmental safety
- Primary containment and additional measures
- Negative pressure areas in aseptic manufacturing
- Decontamination of facilities
- Personnel as critical component in containment
15.45 -16.00 h Break
16.00 - 17.00 h
Decontamination, Virus Inactivation and Virus Removal Techniques
- Decontamination of surfaces
- Validation of decontamination procedures
- Virus inactivation: principles and methods
- Virus removal methods
- GMP issues on virus inactivation and virus removal techniques
17.00 – 17.30 h
Questions and Answers
Programme Day 2
08.30 - 09.30 h
Validation of a Decontamination System for Production Equipment, Process Devices and Cleanrooms
- Different gassing systems
- System qualification
- Validation of a dry fog detergent
09.30 – 10.30 h
Case Study: Concept of Multipurpose Vaccine Production Facility
- Practical issues with flow of material, personnel and waste material
- Clean room qualification
- Segregation of cell preparation, virus production and downstream processing
- Change over procedures for manufacturing campaigns
10.30 – 10.45 h Break
10.45 – 11.45 h
Issues of Staff Safety
- Requirements and Guidelines
- Differences Vaccines Products and Plasma Products
- Use of S3 Coveralls
- Environmental Health and Safety challenges
- Examples from Daily Business
11.45 – 12.15 h
Questions and Answers
12.15 – 13.15 h Break
13.15 – 14.15 h
Case Study: Design, Construction and Qualification of a New Production Line
- Requirements of design
- Issues of construction
- Qualification Challenges
14.15 – 15.15 h
cGMP Issues for Downstream Processing
- General GMP concerns for downstream processing
- (ultra)filtration techniques
- (ultra)centrifugation techniques
- Sterile filtration and aseptic processing
15.15 -15.30 h Break
15.30 – 16.30 h
Case Study: GMP Development and Manufacturing of Recombinant Viral Vaccines for Clinical Trials
- Regulatory expectations for vaccine batches for phase 1/2/3 clinical trials
- Development vs. validation
- Regulatory expectations for implementation of analytical methods – qualification and validation
- Contract manufacturing of IMPD´s
16.30 – 17.00 h
Questions and Answers