Immunoassay & Cell Based Assay

Analytical testing is a critical part in every step of drug development and manufacturing. The qualitative and quantitative results generated from validated analytical testing provide first-hand information to control and ensure the quality and safety of raw materials, intermediates, and finished products. Like many other CMC (chemical, manufacturing and control) activities, analytical testing is also frequently outsourced. Many factors are attributed to this rapid market growth, including continuous outsourcing from pharmaceutical companies, growing pipelines for biological candidates, and increasing demand for more analytical details on drugs and process development by regulatory agencies. In response to the changing market dynamics, service providers are striving to provide analytical testing with quality, accuracy, and robustness all within tight timelines. As the contract research organizations (CROs) have become more integrated, small analytical labs need to establish their niche to succeed. Global contract analytical Laboratories provide QC laboratory analysis, method development, validation and expert advice for both finished products and raw materials for pharmaceutical and biopharmaceutical companies. Quality Compliance testing is done a wide variety of raw material and finished product forms including High Potent Active Pharmaceutical Ingredients (APIs), Raw Materials and Excipients, Powders - Capsules/Semi-solids, Oils - Oral Solutions and Syrups, Liquids, Vitamins, Minerals, and Nutritional, Natural Health Products (NHPs) – Powders, Herbals – Suspensions, Finished Pharmaceutical Products (Tablets, Capsules/Semi-solids, Oral Solutions and Syrups, Gels, Creams and Ointments, Powders, Suspensions, Transdermals etc. Bioanalytical Services for Preclinical and Clinical Studies covers Method Development, Method Validation, Lead Optimization Studies, Pharmacokinetic (PK) Analysis, Bioavailability Studies, Bioequivalence Studies, Dose Formulation Analysis, Clinical Kit Preparation, Sample Handling and Management, GCP Bioanalytical Services. Bioanalytical Technologies including Liquid Chromatography - Mass Spectrometry, Inductively Coupled Plasma – Mass Spectrometry, Capillary Electrophoresis and Nuclear Magnetic Resonance Spectroscopy and Bioanalysis of PEGylated and other Polymer-Linked Drug Assays. Large Molecule Bioanalytical Services include Immunochemistry Services, Quantitative Immunoassays, Immunogenicity Assays, Biomarkers Assays, Cell-Based Neutralization Assays, Ligand-Binding Assays. Immunochemistry services including development, validation and analysis supporting toxicokinetics (TK), pharmacokinetics (PK), immunogenicity and biomarker studies.Immunochemistry, or large molecule bioanalysis, is necessary to gain data on product efficacy, safety, disease state or mechanism of action, which will allow you to make informed and important decisions during biologic drug development. Immunochemistry Services involve Immunoassays, Biomarker Assays, Cell-Based Neutralization Assays, Immunogenicity Assays, Ligand-Binding Assays. Cell-based and ligand-binding assay services are Reporter Gene cell based assays, Enzyme-linked Immunosorbent Assay (ELISA), Mesoscale (MSD) electrochemiluminescence (ECL), Neutralizing antibody assays, Enzyme immunoassay (EIA) including acid dissociation (AD) and Radioimmunoassay(RIA) . Immunoassay Method Development &Validation are Immunogen preparation, Antibody production and labeling , Assay development/transfer and validation. Ligand binding assays (LBA) cover Enzyme Linked Immunosorbent Assay (ELISA) - including assays with Acid Dissociation (AD), Mesoscale (MSD) Electrochemiluminescence (ECL) and Radioimmunoassay (RIA).