DRUG RESIDUE ASSAYS / PROCESS CONTAMINATION ASSAYS
DRUG RESIDUE ASSAYS
Production of a therapeutic drug and vaccine requires, whether by fermentation, cultivation, isolation, or synthesis, usually starts with raw materials and added materials. Subsequent steps of the rocedure involve preparation, characterization and purification of in-process bulk eventually resulting in the therapeutic drug.
The quality and purity of the drug substance can be assured solely by estimation of all additives including anti-microbial used. FDA and EMA guidelines recommend that these be analysed and quantified to ensure minimal levels and to ensure process efficacies during production.
Our assays are optimized for cell culture supernatants which being the primary sample matrix for testing these residues.
BIOPROCESS CONTAMINATION ASSAYS
Product Impurities and host cell proteins (HCPs) are an inevitable impurity of biopharmaceuticals, regardless of whether they are produced by recombinant fermentation or extracted from natural sources. Even after multiple sophisticated purification steps, HCPs and product impurities may remain or co-purify. KRISHGEN offers a variety of ELISA kits validated for impurities of downstream contaminants.
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