Immunization standards

Influenza vaccine production and quality control

Course on Influenza vaccine production and quality control, NVI, The Netherlands

Bilthoven, The Netherlands
30 November - 18 December 2009
in assocation with the International Technology Platform for Influenza Vaccines (ITPIV) and the Initiative for Vaccine Research (IVR)

Netherlands Vaccine Institute (NVI) will organize from 30 November to 18 December 2009, under the auspices of WHO, an intensive practical training course on production and quality control of egg-based influenza vaccines.

Course outline

After a general introduction that concerns global policy of WHO, general vaccinology and more particular the disease, the immune response and the different vaccines against influenza, the training will go into a full consideration of the production process of influenza vaccines. During the course, a pilot scale production batch will be made to illustrate and practice all aspects of the production process including inoculation, incubation, cooling, decapping, harvesting, clarification, zonal centrifugation, inactivation/filtration, diafiltration, buffer addition and sterile filtration. Also the (in process) quality control tests like the EID50, SRID and other necessary QC tests are included in the course. Further more, the course contains regulatory aspects of influenza vaccines and will show the differences between international regions. The training will provide insights and skills needed to work safely and securely. Following draft ICH guidelines Q8 and Q9, a new approach for process development and risk management will be illustrated with the influenza vaccine manufacturing process.

The training will be conducted by NVI experts and international qualified experts. It will be a very interactive and mainly a hands-on training with a thorough theoretical basis. The interactions between the NVI staff working on influenza vaccines will be combined with state of the art seminars. This combination will make sure that the training provides comprehensive knowledge on all aspects of the influenza vaccine technology.

Application

The course is designed for participants that come from a manufacturer from a low- or middle-income country that has taken steps to initiate or improve their current manufacturing capabilities for influenza vaccine manufacturing, both seasonal and pandemic. Manufacturers interested to submit candidates to this course are encouraged to nominate two persons simultaneously: one from production and one from quality control.

Interested candidates should send their application letter with their curriculum vitae to NVI itpiv@nvi-vaccin.nl. The deadline for application is 15 August 2009. Generic GTN/VQ application form should not be used for applying to this course.

Applications will be selected in consultation with WHO/IVR and will be informed before 15 September 2009. Accepted applicants can apply to WHO if needed for reimbursement of travel costs and a per diem.

The maximum number of participants will be limited to 10 only.

For further details, please contact Marit Holleman marit.holleman@nvi-vaccin.nl or itpiv@nvi-vaccin.nl .