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.
An immunoassay measures the amount of a targeted substance in solutions that may contain a number of elements. Immunoassays can determine whether specific analytes are present in a biological sample such as serum, and the quantity of the analyte if it is present. These types of tests depend on the specific binding ability of an antibody to join with individuals in limited groups of molecules. Molecules that bind to antibodies are known as antigens.
Immunoassays can target either contingent of the antibody and antigen duo. In the case of an antigen immunoassay, lab technicians can also, with correct preparation, employ the antibody that binds to the antigen as the analytical reagent, or substance used to quantify a chemical reaction.
An immunoassay, such as the real-time immuno PCR (iqPCR) or proximity ligation assay, serves to identify and then quantify the response, or chemical reaction, that results from target-specific binding. To simplify quantification, contemporary immunoassay protocol calls for detectable labels, such as fluorescent or phosphorescent dyes that illuminate the multiplication of analytes. Other quantification markers used in other types of nucleic acid therapy testing include radioactive elements used in a radioimmunoassay, magnetic particles, coenzymes, and several more.
These labels, or markers, make it possible for laboratory personnel to detect and quantify the occurrence of binding, either subsequent to the separation of free and bound reagents or during the binding itself. With the help of control calibrators containing specific analyte concentrations, technicians can determine the assay response of the test sample using comparative evaluation techniques as well as tools such as the calibration curve.
Quantitative immunoassays are used to measure the amount of biologics therapeutic products in a biologic matrix such as plasma or serum. Immunoassays are based on the specific binding ability of an antibody and are used to determine the safety and efficacy of biopharmaceuticals through toxicokinetic (TK) and clinical pharmacokinetic (PK) support services for therapeutic macromolecules.
Quantitative immunoassay such as Ligand binding assays can be difficult to develop and validate. Their unique challenges include establishing method selectivity, specificity and range of quantitation as a result of nonspecific background signal, matrix interference, lack of linearity (prozone/hook effect) and antibody interference. Selection of the appropriate assay format, and purity / quality of reagents is also critical for robust and reliable data.
CRO’s have capabilities for quantitative immunoassays include developing methods for biologics and biosimilars, method transfer, optimization and validation of existing methods (including kit assays) suitable for use in toxicokinetic (TK) and clinical pharmacokinetic (PK) studies. Utilizing a variety of detection platforms, including enzyme-linked immunosorbent assay (ELISA), electrochemiluminescence (ECL) and radioimmunoassay (RIA) assays, we follow Good Laboratory Practice (GLP) guidelines to provide accurate test results and verifiable, reproducible data that can assist you in compressing timelines whilst meeting the requirements for the drug approval process.
Bioanalytical services include LC-MS/MS Bioanalysis , Metals & Inorganic Bioanalysis, Rapid Discovery Phase Bioanalysis, Ocular Tissue Bioanalysis, Quantitative Immunoassays (ELISA & ECL Platforms), Sample Handling and Management, Clinical & Preclinical Pharmacokinetics.