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Manufacturing
ATTITUDE & SKILL OF THE PERSONNEL AND PRECISION OF THE EQUIPMENT REFLECTS IN THE EXCELLENCE AND QUALITY OF THE PRODUCT THAT HAS BEEN USED BY YOU.
The whole manufacturing procedure is divided into two stages.
- Extraction of Crude Hormone
- Purification of crude Hormone
A few concepts of interest that are involved in the manufacturing process are briefly expressed here under.
Manufacturing Area:
“Class One Lakh” area where the particles of 0.5 micron size will not be more than One Lakh> per cubic feet of air - Washing area. “Class Ten Thousand” area where the particles of 0.5micron size will not be more than Ten Thousand per cubic feet of air - Sterilizing area. “Class One Hundred” area where the particles of 0.5micron size will not be more than One Hundred per cubic feet of air - Filling area.
Dialysis:
Proteins can be separated by > dialysis through a semi-permiable membrane such as cellulose membrane with pores - a common technique involved in purification of blood.
Salting out: Protein fractionating technique. The solubility of most proteins is lowered at high concentrations, called salting out. The dependence of solubility on salt concentrations differs from one protein to another. Hence salting out is used for fractionating proteins in the crude hormone.
Salting out: Protein fractionating technique. The solubility of most proteins is lowered at high concentrations, called salting out. The dependence of solubility on salt concentrations differs from one protein to another. Hence salting out is used for fractionating proteins in the crude hormone.
Column Chromatography: The Proteins can be separated on the basis of their net charge by ion exchange chromatography - as in water filters.
Affinity Chromatography: is another powerful and generally applicable means of purifying proteins. The technique takes advantage of the high affinity of many proteins for specific chemical groups.
More discriminating separation on the basis of size can be achieved by the technique called Gel Filtration Chromatography, which has much to do with clinical efficacy of the final product.
For instance , the purified hCG is of 500-600 I.U./mg strength and after purification by column chromatography, the strength increase to five folds and exceeds the standards of I.P. [Indian Pharmacopoeia] which is 2500 I.U./mg.
The crude hCG after initial purification will be sent to the Biological LAB for Bioassay and approved. The batch that is not approved will be returned back for further purification.
The final product is lyophilized (freeze dried) to retain the efficacy during the shelf-life.
Manufacturing process and evaluation at Bio Lab work in tandem in offering a satisfactory final product. |
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