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The core strength of the Company is its capability to develop and manufacture immunoassay kits based on ELISA technology. The Company undertakes contract research and/or commercial scale manufacture of ELISA kits to detailed specifications and stringent quality control stipulated by the Clients. All Quality Control Data is made available for inspection by the Client. In case of any queries, please email to jayant@amartransgenics.comin confidence.
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The research and manufacturing facilities are managed by highly skilled personnel, having Doctorate and Master of Science Degrees and who have more than 40 years of experience between them. The company has been developing kits for the past 25 years.
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The Company is a leading manufacturer of ELISA kits in India and has its manufacturing facility in Hyderabad, India. The facility has a capacity to manufacture 200,000 plates in a year. The company conducts stability tests to guarantee a minimum shelf life of two years for all its plates. The Coefficient of Variation between wells manufactured by this facility is usually less than 3%. The Company has perfected a unique process to manufacture plates without any “edge effects”.
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The company has necessary cold chain infrastructure, with cold rooms to stock finished kits and components, separately.
The company uses Anti human IgM (heavy chain specific) and Streptavidin coated plates in Capture Assay format, on specific request from Clients seeking contract manufacturing.
The company uses MilliQ grade Endotoxin free water for all reagents preparation.
All reagents used in the facility for manufacturing are sterile filtered and dispensed under sterile conditions.
 
 
The Company raises its own polyclonal antibodies in a modern Animal House that houses New Zeland White Rabbits, Balb/C Mice and Goats.
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Antibody conjugation with Enzymes ( HRPO or Alkaline phosphatase), Biotin or FITC
 
The Company has perfected a unique conjugation protocol to ensure reproducibility and long term stability. It also avoids antibody aggregates. The conjugates are stabilized and provided in a ready to use diluted form.
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Contract development of ELISA kits
 
The Company has been undertaking contract development of ELISA kits for European and American companies. The company has developed more than 20 ELISA kits in the past 8 years. Specifically, two kits developed by the company have been approved by a large American Multinational Corporation for commercial use worldwide. The company has been following American FDA guidelines and provides following data for the kit.
Sensitivity and Specificity, Limit of Detection ( LOD), Limit of Quantification ( LOQ),
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Linearity, Hook Effect, Intra Assay and Inter Assay Variability, Cross Reactivity, Matrix Effect, Uniformity of Results over entire plate, Spike Recovery, CV, Long Term Stability, Multi Plate, Multi Analyst, Multi Day Testing and additional data as per clients specifications.
 
Monoclonal antibody development work
 
The company has set up a modern tissue culture lab strictly for development of mouse monoclonal antibodies. The dedicated tissue culture room contains CE approved biological hood, Olympus Inverted microscope, regular compound microscope, pH meter, centrifuge, co2 incubator, refrigerator and water bath.
The facility also includes MilliQ water purification system, minus 80 o C freezer,
Liquid N2 tank to store Hybrodima cells and Refrigerated Centrifuge.
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Hybridoma cells are normally re cloned twice and tested for isotype specific heavy and light chain.
 
 
The company uses salt precipitation, ion exchange, gel filtration and Protein G or Protein A affinity purification protocols to purify the antibody. The purity of the resultant antibody is also checked by SDS PAGE electrophoresis and/or western blot procedures.
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PCR set up to do qualitative testing
 
The company also has a facility to do qualitative PCR testing. The company provides GMO testing service for several seed companies.
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