Bio-Analytical Services
We offer extensive range of equipment and highly-trained personnel for Bio-Analytical services in advanced facilities for custom method development, assay validation, and sample analysis using modern LC-MS/MS, ICP-OES & ICP-MS equipment to support Pharmaceutical NCE and Generic Drug Development.
The competency to handle liquid-liquid extractions, solid-phase extractions and pre-column | post-column derivatization procedures, Chiral separation of optical isomers as well as Conjugate and non-Conjugate drug level estimation.
The Bio-Analytical Team will develop a deep understanding of the specific regulatory requirements of international regulatory agencies such as FDA, EMEA, ANVISA, WHO, MCC, TGA and DCGI.
The method data bank offers new drug assays, with the standards set by international regulatory authorities.
Method Development and Validation
All analytical methods developed and validated are compliant with latest international regulatory requirements with precision recovery and stability checks from In Process Quality Control Team. We provide clinical assay or develop a method from scratch and validate the assay for the bio-analysis in a cost effective and timely manner. The staff has developed Bio-Analytical methods including routinely quantifying levels in pg/ml.
Development of validated assays for multiple analytes, metabolites, prodrugs and light and temperature-sensitive compounds in various biological matrices. Using experience in similar molecules, the method development team discusses and develops the research plan.
All the method validations are performed according to Good Laboratory Practices (GLP), regulatory guidance and in-house SOPs to ensure that the developed assays demonstrated linearity, recovery, reproducibility, specificity, accuracy and stability under all conditions.
Bio Sample Analysis
The significant expertise in stringent Bio-Analytical methodologies and processes promises the fast and rapid sample processing throughput and quality data. Performing of a Incurred Sample Reanalysis (ISR) is in strict compliance with the protocol and regulatory requirement.
All study samples will be stored in secure freezers with temperatures ranging from 2°- 8° C – 20° C and -80° C. These freezers are monitored round the clock with power backup.
Infrastructure
Accredited Central Bio-Analytical facility includes:
- Adequate bio-analytical area
- Spacious Sample Preparation Labs
- 26 LC-MS/MS
- Dedicated Servers for LC-MS/MS data
- 5 HPLC-UV/Fluorescent Detectors
- 2 ICP-OES & 1 ICP-MS for Trace Metal Analysis
- Networked Chromatographic Data Management (Scientific Data Management System NuGenesis®)
- Solid Phase Extraction Systems
- Nitrogen Evaporators
- Refrigerated Centrifuges
- Automatic temperature recording device
All systems must use validated software that is 21 CFR Part 11 compliant. The Bio-Analytical data is electronically transferred and documented. All studies are scrutinized by the QA Department and subjected to periodic in-house audits to ensure compliance.