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
Virus Inactivation and Virus Removal Techniques
- Validation of virus inactivation step
- Virus inactivation: principles and methods
- Virus removal Methods
- GMP issues on virus inactivation and virus removal techniques
Validation of a Decontamination System for Production Equipment, Process Devices and Cleanrooms
- Different gassing Systems
- System qualification
- Validation of a dry fog detergent
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
Modern Vaccines Part II – GMP Inspectors‘ View
- Regulatory expectations
- Classic vaccines
- Aspects for modern vaccines, e.g. mRNA and protein-based
- Experiences from inspections
cGMP Issues for Upstream Processing
- General GMP concerns for upstream processing
- Raw materials and media preparation
- Cell culture
- Virus culture
- Inactivation of microorganisms
Issues of Staff Safety
- Requirements and Guidelines
- Differences vaccines products and plasma products
- Use of S3 Coveralls
- Environmental health and safety challenges
- xamples from daily Business
Case Study: Isolator Filling Line for Vaccines
- Requirements of design
- Issues of construction
- Qualification challenges
cGMP Issues for Downstream Processing
- General GMP concerns for downstream processing
- (Ultra)filtration techniques
- (Ultra)centrifugation techniques
- Sterile filtration and aseptic processing
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 IMPDs