Product sub-groups – Host cell protein contamination detection

Custom Services provided Assay Format Requirements from end-user Guidelines to be followed Pricing
Customized assay development of HCP detection for novel/ unique host-specific systems : ELISA Cell-free lysate containing mixture of HCPs; Purified HCP (if available); Antibody (if available)    
Hansenula polymorpha (yeast)     ICH Q6B  
Saccharaomyces cerevisiae (yeast)     FDA  
Insect cell lines – Sf9, Sf21, High Five strains     EMA guideline CPMP/BWP/382/97  
Mammalian cell lines (HeLa, HEK 293)        
Murine cell line (SP 2/0)        
CHO & E. coli generic HCP detection kits        
CHO & E. coli process-specific HCP detection kits        

Product sub-groups – Residual Impurities detection for Quality Control

Custom Services provided Assay Format Requirements from end-user Guidelines to be followed Pricing
Residual Kanamycin detection kit ELISA Samples ICH QB6  
Residual Gentamycin        
Residual Enterokinase        
Residual Amino acid detection        

Product sub-groups – In-vitro Biological assays

Custom Services provided Assay Format Requirements from end-user Guidelines to be followed Pricing
Perform and/or develop specific biological assays for therapeutic peptides/ proteins/ enzymes :        
1. Chymotrypsin Enzyme activity assay Samples    
Hyaluronidase Turbidometric enzyme assay Samples    
Streptokinase Chromogenic enzyme assay Samples Drug Monograph  
Urokinase Chromogenic enzyme assay Samples Drug Monograph  
Heparin (Unfractionated) & Enoxaparin (LMWH) anti-F-IIa & Xa assays Samples US-FDA & EMA guidelines  
Heparin (Unfractionated) & Enoxaparin (LMWH) anti-F-IIa & Xa assays Samples US-FDA & EMA guidelines  
Direct Thrombin Inhibitors (Bivalirudin, Hirudin etc.) Chromogenic assay Samples & References Drug Monograph  
IgG quantification ELISA Samples    

Product sub-groups – Pharmacokinetic assays for therapeutic biologics

Custom Services provided Assay Format Requirements from end-user Guidelines to be followed Pricing
Samples: Therapeutic mAbs, hormones, cytokines Ligand binding assay 2. Titer-determination assay Samples US-FDA, EMA guidelines  
Filgrastim ELISA      
Insulin Lispro        
Insulin Glargine        
Epoetin alpha        
Trastuzumab        
Infliximab        
Adalimumab        
Bevacizumab        
Rituximab        
Cetuximab        

Product sub-groups – Immunogenicity testing of therapeutic biologics

Custom Services provided Assay Format Requirements from end-user Guidelines to be followed Pricing
(i) Screening & Confirmatory tests for the detection of anti-drug antibody (ADA) species ELISA Samples US-FDA, EMA guidelines  
(ii) Characterization of ADA species – class, sub-class, isotype determination ELISA      
(iii) Determination of Neutralizing ability of ADA species – NAb-ADA titer determination Competitive Ligand binding ELISA      
Samples: Therapeutic mAbs, hormones, cytokines        

Product sub-groups – Glycan analysis (Consultation & technical support)

Custom Services provided Assay Format Requirements from end-user Guidelines to be followed Pricing
N-glycan analysis Kit/ Reagent based Consultation & technical support (non-experimental support) ICH documents Q5E and Q6B  
O-glycan analysis        
Glycan site identification        
Sialic acid quantitation        
Glycan charge analysis        
Monosachharide analysis        

Product sub-groups – Testing of Plasma products

Custom Services provided Assay Format Requirements from end-user Guidelines to be followed Pricing
Albumin, Intravenous IgG, Blood clotting factors ELISA-based & Chromogenic assays Samples    

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