Quality control of Hib conjugate vaccines
Course on quality control of Hib conjugate vaccines at the Netherlands Vaccine Institute (NVI)
This course is designed to enable staff from vaccine manufacturers and national control authorities from developing countries to upgrade their knowledge in relevant areas of Quality Control (QC) of Haemophilus influenzae type b (Hib) conjugate vaccines. The main focus is the upgrading of individual skills and know-how. It is anticipated that through this course, implementation of the QC methods will be facilitated at the participant's home institution. Newly-acquired knowledge should also facilitate understanding of validation issues pertaining to these QC tests.
The course is designed for a two-week period and targeted for senior scientific QC personnel, including managers, who want to upgrade their knowledge in QC testing of Hib conjugate vaccines and related products (multivalent formulations, conjugates from other serotypes). A background in chemistry is an advantage, but not a requirement. Because the main part of the course includes hands-on bench work, the number of participants is limited to ten.
This training course includes all aspects of Hib conjugate QC testing, and is based on the WHO Hib conjugate regulations. The program includes several sessions to explain the specific regulations and theoretical background. Case studies are used to familiarize the participants with the practical application of the WHO Hib conjugate regulations. Real-life cases based on the experience of the participants can also be included in the discussions. Participants will do practical bench work with the various QC tests on a daily basis. Participants will also receive the necessary information about the preparation and testing of critical reagents such as reference preparations, antisera and media. Relevant literature and regulations are supplied to the participants to be used as reference materials both during and after the course.
The main topics that are included in the programme are as follows:
- composition analysis of Hib polysaccharide (PRP) including detection of some contaminants (proteins, nucleic acids)
- determination of molecular mass by HPLC
- analysis of the main intermediate product (modification ratio of PRP-ADH)
- analysis of liquid Hib conjugate bulk (PRP to protein ratio) including detection of the main contaminant (free PRP)
- quantitative (PRP ELISA) and qualitative (antigenicity ELISA) immunological assays
A comprehensive course manual consisting of modules addressing specific topics, with all hands-on documents and references, will be handed out to the participants (on paper as well as on CD-ROM).
How to apply
The course is organized by WHO GTN/VQ in collaboration with the Netherlands Vaccine Institute. Candidates should complete a GTN course application form that can be downloaded from GTN website:
Forms should be routed from country offices to WHO Regional Offices for clearance and to be forwarded to GTN coordination unit in WHO Headquarters before the deadline. As for deadlines, the GTN annual calendar should be consulted. Applicants will be selected by WHO in consultation with NVI and will receive notice about four weeks before the course starts.
Netherlands Vaccine Institute (NVI)
For further information please contact:
The Netherlands Vaccine Institute (NVI) was created in 2003 from the former Vaccine Division of the National Institute for Public Health and the Environment (RIVM). This new government-based agency reflects thereby more than 100 years of extensive knowledge and experience gained through vaccine research and production. NVI’s mission is to guarantee (by procurement or own production) the supply of vaccines necessary to protect the Dutch population against infectious diseases. To achieve its mission, the institute strives to enter into strategic collaborations with various partners such as international pharmaceutical companies. Such collaborations include the exchange of knowledge and products, and cooperation in research and product development. The NVI further cooperates with vaccine producers in developing countries notably in Indonesia and India. The NVI functions as a training centre and a resource institute for WHO’s Global Training Network on Vaccine Quality and for the DCVMN. NVI also houses the WHO Collaborating Centre for Smallpox Vaccine.
Dr Umit Kartoglu
World Health Organization
20, Avenue Appia
CH-1211 Geneva 27
Tel: + 41 22 791 4972
Fax: + 41 22 791 4384
GTN cHib Course Secretary
Netherlands Vaccine Institute (NVI)
P.O.Box 457, 3720 AL Bilthoven
Mobile: +31 30 274 3042
Fax: +31 30 274 442