Detailed Professional Experience
Production and filling of 8 different sterile vaccines under aseptic conditions in a GMP regulated facility.
Production of bacteriological antigens by fermentation technology up to 5000 liter batch size. Bacteria used:
anaerobe bacteria
- Clostridium perfringens A, C, D,
- Clostridium septicum,
- Clostririum novyi,
- Clostridium chauvoei,
- Clostridium tetani,
aerobe bacteria
- Pasteurella multocida,
- Pasteurella haemolytica,
- Salmonella enteritidis,
- Escherichia coli,
- Mycoplasma hyopneumoniae,
- Actinobacillus pleuropneumoniae,
- Streptococcus pyogenes,
microaerofil bacteria
- Avibacterium paragallinarum
Production of viral antigens in bioreactors up to 4500 liter batch size. Viruses used:
- PCV2 on PK15 cell line,
- PRRS on MA104 cell line.
Facility, utility and technology design of an 1500 m2 production facility for bacterial antigen and vaccine production and sterile filling. Special expertise in aseptic process and closed system production design.
Design of an 1300 m2 production facility for viral antigen production in bioreactors.
Expert knowledge of fermentation engineering principles. Stat-up of 5 new fermentation lines including:
- user requirement specification preparation,
- supplier selection,
- project support,
- factory and site acceptance testing
- IQ/OQ/PQ of the lines.
Stat-up of 3 new bioreactor lines including the same above activities.
Transfer of 4 vaccine technologies from Ceva-Phylaxia R&D to production.
Transfer of 6 bacterial antigen technologies from Ceva-Phylaxia R&D to production.
Transfer of 2 viral antigen technologies from a competitor to Ceva-Phylaxia production.
Hand-on experience in handling of fermenters, bioreactors, separators, homogenizators, TFF machines, filling machine.
Experience maximizing the output of fermentation vessels.
Support of regular GMP qualifications and process validations.
Ability to write SOPs.
Involved in the development of electronic documentation systems.