Biopharmaceuticals can be summarized as “any virus, therapeutic serum, toxin, antitoxin or analogous product applicable to the prevention, treatment or cure of diseases or injuries of man”. Prior to their commercial release in this highly regulated present-day market, biopharmaceuticals need to be thoroughly tested for their efficacy, stability, presence of contaminants and lot/batch variations as per pharmacopeial guidelines set by regulatory authorities like USP, EMA, FDA etc.
Krishgen offers to its customers, kit-based assays and reagents for the testing of a wide range of biopharmaceuticals including therapeutic monoclonal antibodies, hormones, growth factors, enzymes and vaccines. Developed in compliance to IP/EP/USP guidelines, our kits are highly validated and specific for each class of biopharmaceuticals.
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