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Analytical Methods for the Development of Haemophilus influenza virus b Vaccine

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  1. Introduction to analytical methods
  2. Introduction of hib vaccine
  3. Literature review
  4. Equipments used and method development
  5. Results and discussion
  6. Conclusion
  7. Bibliography

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.

[...] Although HPLC is widely considered to be a technique mainly for biotechnological, biomedical, and biochemical research as well as for the pharmaceutical industry, these fields currently comprise only about 50% of HPLC users. Currently HPLC is used by a variety of fields including cosmetics, energy, food, and environmental industries. High Performance Liquid Chromatography (HPLC) HPLC originally referred to the fact that high pressure was needed to generate the flow required for liquid chromatography in packed columns. In the beginning, instrument components only had the capability of generating pressures of 500psi (35 bar). [...]

[...] SUMMARY The research work embodied in this dissertation for the analysis of Haemophilus influenzae virus b vaccine using Analytical methods. Was carried out at analytical research and development Dept. of Panacea Biotec. Ltd. Punjab. The dissertation work reported here is organized in a systematic manner: Chapter Classifies different analytical methods with emphasis on liquid chromatography. It also lay out a general plan for HPLC method and introduction of hib vaccine. Chapter Includes a literature review of the components and methods for its analysis. [...]

[...] In particular the invention relates to a vaccine formulation for the prevention of Haemophilus Influenzae Type B (Hib) infections and where the antigen was adsorbed on to aluminium phosphate. The invention also relates to a multivalent vaccine, that was a vaccine for the amelioration or treatment of more than one disease states. The present invention also relates to the production and use of such vaccines in medicine. Vaccines that utilize polysaccharides are known in the art. For example a vaccine for the prevention of Haemophilus influenzae b (Hib) infections were based on the capsular polysaccharide (PRP) conjugated with a carrier protein. [...]

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