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. [...]
[...] A = volume of the sample taken for titration To develop method for the estimation of phenoxy ethanol in Hib vaccine Strategy: To develop a U.V method and HPLC method. Initial trial: U.V method development: Preparation of solutions: Blank: 1,2 di chloro ethane Control standard: 50mmol/l of phenoxy ethanol. Prep: 1.12 ml of phenoxy ethanol dissolved in 50 ml of 1,2 dichloro ethane. Stock Standard : 100mmol/l of phenoxy ethanol. Prep: 2.24 ml of phenoxy ethanol dissolves in 100 ml of 1,2 dichloro ethane. [...]
[...] Analytical chemistry deals with methods for determining the chemical composition of samples. A compound can be often measured by several methods. The choice of analytical methodology is based on many considerations, such as chemical properties of the analyte and its concentration, sample matrix, the speed and cost of the analysis, type of measurements i.e, quantitative or qualitative and the number of samples. A qualitative method provides numerical information regarding the relative amounts of one or more of the species ( the analytes) in the sample. [...]
[...] General Consideration for HPLC Method DEVELOPMENT Flow Chart Method Development Flow Chart Gather information from the literature for the Physiochemical properties of the API (From Literature, Internet, etc.) Determine solubility profile and Select Detector λ max Select chromatography method (Based on solubility study, Retention of the compounds etc.) Reverse Phase Chromatography Normal Phase Chromatography [Water soluble API (ionic/ non-ionic), [API Soluble in Non-polar organic solvent, organic soluble API (polar or non-polar) etc] Sample too hydrophilic or hydrophobic etc] Perform Initial run for HPLC conditions Select gradient or Isocratic mode Perform trials to select the optimum conditions for separation (By changing Mobile Phase Composition, Buffer, pH, Column, Flow Rate, Temperature etc) Perform degradation experiments to challenge the method Define System Suitability Parameters Summarize Methodology Prepare Development Report Validate the Method Vaccine Profile Introduction of Haemophilus influenzae type b Vaccine The Hib bacterium Haemophilus influenzae type b is one of six types and of encapsulated strains of the bacteria. [...]
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