Bio-analytical Services

The bio-analytical laboratory at Reliance Life Sciences is equipped with state-of-the-art instrumentation and automation equipment for performing a diverse range of analyses on biological samples. The SOPs comply with Good Laboratory Practices and continuously evolve to keep pace with the requirements of international regulatory agencies and the pharmaceutical industry. The bio-analytical team is highly experienced and has good understanding of GLP and Regulatory guidelines.

Infrastructure:

• LCMS/MS – Sciex API-3000, API-3200 Q-Trap, API-4000 & API 5500 (latest version)
• Enzyme-Linked Immuno-Sorbent Assay (ELISA)
• High speed refrigerated centrifuges
• Solid phase extraction system, both manifold and positive pressure (144 cartridge capacity)
• Different extraction technique like Liquid-Liquid Extraction, Solid Phase Extraction, Protein Precipitation
• Large molecule analysis using LCMS/MS
• Walk-in cold rooms for -20^oC
• Deep freezers -70°C and -20°C and refrigerator (temperature is constantly monitored through wireless data logger with a security alarm system)
• Updated 21 CFR part 11 compliant chromatographic/mass analysis software
• Separate instrumentation lab
• Isolated weighing room
• Separate processing room for light sensitive molecules
• Laboratory Information Management System
• Quality Assurance Management System
• Document Management System
• Complete GLP laboratory

The service offerings include:

Pre-clinical:

• Bioavailability/ screening
• Protein binding studies
• Metabolism (mass balance, identification and quantitation)
• Toxicokinetic studies
• Formulation analysis & evaluation of stability studies

BA/BE & Phase I - IV:

• Drug interaction studies
• Studies on Schedule X drugs (Narcotics and Psychotropic drugs)

Expertise:

• Rapid development and validation of new analytical methods
• Execution of most complex analytical projects
• Method development of Large molecules using (ELISA and LC/MS-MS techniques)
• Adaptation and revalidation of sponsor’s assay methods
• Bio-analysis of drugs for pre-clinical and clinical studies
• Sample analysis of Proteins, Peptides, Olegoneucleotide and mAbs.
• Sample analysis in different matrices

Some of the Key Methods:

Small molecules:

• Quantitative estimation of Alendronate (by diazomethane derivatization) from human urine samples using LC-MS/MS technique
• Simultaneous quantitative estimation of UDCA, and its conjugates GDCA, and TDCA from human plasma samples using LC-MS/MS technique
• Simultaneous quantitative estimation of Metfromin, Glimepiride, Pioglitazone and Hydroxy metabolite of Pioglitazone from human plasma samples using LC-MS/MS technique
• Quantitative estimation of Tetrahydrobiopterin or BH4 (Sapropterin) from human plasma samples using LC-MS/MS technique
• Simultaneous quantitative estimation of Selegiline and its metabolites N-Desmethylselegiline, Methamphetamine and Amphetamine from human plasma samples using LC-MS/MS technique
• Quantitative estimation of Lithium from human serum and plasma samples using LC-MS/MS technique
• Quantitative estimation of Zopiclone S and R enantiomers from human plasma samples using LC/MS-MS technique
• Quantitative estimation of Fingolimod from human blood using LC/MS-MS technique
• Quantitative estimation of Levodopa and Carbidopa from human plasma using LC/MS-MS technique
• Determination of Dabigatran (Free) in Human Plasma using LC/MS-MS technique
• Determination of Dabigatran (Total) in Human Heparin Plasma using LC/MS-MS technique
• Simultaneous quantitative estimation of Spironolactone and its metabolites Canrenone and 7α-Thiomethyl Spironolactone in Human Plasma using LC/MS-MS technique
• Simultaneous quantitative estimation of Efavirenz, Lamivudine and Tenofovir in Human Plasma using LC/MS-MS technique.
• Simultaneous quantitative estimation of Nicergoline and its metabolite in Human Plasma using LC/MS-MS technique.

Large molecules:

• Quantitative estimation of Erythropoietin from human serum samples using advanced Automated ELISA system
• Quantitative estimation of Bevacizumab from human serum samples using ELISA technique
• Quantitative estimation of PEG GCSF from human serum samples using ELISA technique
• Quantitative estimation of Etanercept from human serum samples using in-house developed kit for ELISA technique
• Quantitative estimation of Trastuzumab from human serum samples using LC/MS-MS technique
• Quantitative estimation of Cetuximab from human serum samples using LC/MS-MS technique

Validated Methods:

Reliance Life Sciences has more than 265 validated bio-analytical methods for quantitative estimation of drugs and metabolites from various biological fluids. To download the list of validated Bioanalytical methods available, click here.