Proteomics

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. CRO’s help to conduct intact protein analysis including protein identification and protein characterization faster and more completely with automated chip-based nanoelectrospray. Services include Identification of faint gel spots with high-quality electrospray ionization MS/MS, Convert low-abundance MS/MS data into high-quality identifications with infusion for improved signal-to-noise, Achieve 75 fmol detection limits of protein loaded on a gel and Zero sample-to-sample carryover. 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. Proteomics Services covers Protein ID – Mass spec ESI-MS/MS based, MS analysis of intact proteins and peptides, Labelled and Label-free Protein Mass-Spectrometry, Differential Proteomics and Peptide mass fingerprinting.