Analytical Methods for the Development of Haemophilus influenza virus b Vaccine

Type :

Theses

Pages :

44 pages

Format :

.doc

Published date :

05/26/2009

Category :

Science & technology

Sub category :

Medical studies

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Summary :

Introduction to analytical methods
Introduction of hib vaccine
Literature review
Equipments used and method development
Results and discussion
Conclusion
Bibliography

Abstract

The ability to provide timely, accurate, and reliable data is central to the discovery, development, and manufacture of biopharmaceuticals. analytical data are used to screen potential vaccine candidates, aid in the development of vaccine synthesis, support formulation studies, monitor the stability of bulk biopharmaceuticals and formulated products, and test final products for release. The quality of analytical data is a key factor in the success of a vaccine development program.

Problems increase as additional people, laboratories and equipments are used to perform the method. When the method is used in the developer's laboratory, a small optimization can usually be made to make the method work, but the flexibility to change it is lost, once the method is transferred to other laboratories or used for official product testing, where methods are submitted to regulatory agencies and changes may require formal approval before they can be implemented for official testing. The best way to minimize method problems is to perform adequate validation experiments during development.

The need of the sophisticated analytical instruments and determination using them is almost a routine process for the modern analytical laboratories. It has been vast expanding areas of knowledge as the instrument automation is in ever-increase in power and scope. Further all the manual techniques in the line of analytical studies had steadily been transferred to the instrumental techniques. analytical methods are generally classified as Physical and Chemical analysis. Physical analysis includes measurement of particle size, dimension, thickens of a solid dosage forms etc. Basically chemical analysis can be divided into three broad categories.