Product sub-groups – Host cell protein contamination detection

Custom Services providedAssay FormatRequirements from end-userGuidelines to be followedPricing
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)
1. Hansenula polymorpha (yeast) ICH Q6B
2. Saccharaomyces cerevisiae (yeast) FDA
3. Insect cell lines – Sf9, Sf21, High Five strains EMA guideline CPMP/BWP/382/97
4. Mammalian cell lines (HeLa, HEK 293)
5. Murine cell line (SP 2/0)
6. CHO & E. coli generic HCP detection kits
7. CHO & E. coli process-specific HCP detection kits

Product sub-groups – Residual Impurities detection for Quality Control

Custom Services providedAssay FormatRequirements from end-userGuidelines to be followedPricing
1. Residual Kanamycin detection kit ELISA Samples ICH QB6
2. Residual Gentamycin
3. Residual Enterokinase
4. Residual Amino acid detection

Product sub-groups – In-vitro Biological assays

Custom Services providedAssay FormatRequirements from end-userGuidelines to be followedPricing
Perform and/or develop specific biological assays for therapeutic peptides/ proteins/ enzymes :
1. Chymotrypsin Enzyme activity assay Samples
2. Hyaluronidase Turbidometric enzyme assay Samples
3. Streptokinase Chromogenic enzyme assay Samples Drug Monograph
4. Urokinase Chromogenic enzyme assay Samples Drug Monograph
5. Heparin (Unfractionated) & Enoxaparin (LMWH) anti-F-IIa & Xa assays Samples US-FDA & EMA guidelines
5. Heparin neutralization assays (Heparinase based) anti-F-IIa & Xa assays Samples US-FDA & EMA guidelines
6. Direct Thrombin Inhibitors (Bivalirudin, Hirudin etc.) Chromogenic assay Samples & References Drug Monograph
7. IgG quantification ELISA Samples

Product sub-groups – Pharmacokinetic assays for therapeutic biologics

Custom Services providedAssay FormatRequirements from end-userGuidelines to be followedPricing
Samples: Therapeutic mAbs, hormones, cytokines 1. 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 providedAssay FormatRequirements from end-userGuidelines to be followedPricing
(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 providedAssay FormatRequirements from end-userGuidelines to be followedPricing
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 providedAssay FormatRequirements from end-userGuidelines to be followedPricing
Albumin, Intravenous IgG, Blood clotting factors ELISA-based & Chromogenic assays Samples

Contact Application Specialist

Ritesh Panchal

Application Specialist

Tel No.: 022 249198717