Bioanalytical Research Laboratory
Bioanalytical Research Laboratory at Clinigene is involved in the analysis of drugs and/or active metabolites from biological matrices in support of Bioavailability (BA), Bioequivalence (BE) and Pharmacokinetic (PK) studies as part of the early clinical development programs. We also undertake bioanalysis for Therapeutic Drug Monitoring (TDM) studies. The laboratory offers development, validation and application of the analytical methods for various pharmacologically active moieties in different biological matrices.
With the state-of-the-art instrumentation including LC-MS/MS, HPLC and UPLC, the laboratory provides services to meet the quality parameters as well as timelines. With its highly skilled and experienced researchers, the laboratory possesses competency in development, validation and transfer of the bioanalytical method.
Our functions follow applicable GLP principles with comprehensive SOPs implemented for various activities in the laboratory. Each activity is closely monitored by the QA personnel for compliance with SOPs, protocol as well as applicable national and international regulatory requirements. At Clinigene, we are committed to provide quality bioanalytical services with a rapid turnaround time.
Infrastructure
- Facility spread over an area of 7500 sq.ft.
- State-of-the-art instrumentation [with Qualification]
- LC-MS/MS (API 4000, 3 nos and API 4000 QTrap, 1 no) with ESI and APCI sources
- HPLC (Waters Alliance, 1 no) with separation module and PDA and Fluorescence detectors
- UPLC with PDA detector
- Software
- Analyst (LC-MS/MS) and MetID
- Empower (HPLC and UPLC)
- Watson™(Laboratory Information Management System)
- Nugenesis® (Scientific Data Management System)
- Pharmacokinetic Analysis – WinNonlin™ Enterprise
Expertise
- Development of bioanalytical methods for drugs and/or metabolites using LC-MS/MS or HPLC/UPLC
- Experience in bioanalysis of wide range of drug molecules including peptides
- Bioanalytical report preparation and review
- Bioanalysis to support BA, BE, PK, early clinical development and TDM studies
List of validated methods
Services
- Development and validation of bioanalytical methods for analysis of drug(s) and/ or active metabolite(s) in biological matrices (e.g. blood, plasma, serum, urine, etc.), and application of method for clinical PK (including Phase I/Phase II)/TDM studies
- Development, validation and transfer of bioanalytical method
- Adoption and partial validation of the bioanalytical methods transferred by sponsor
- Development of protocols for method development, method validation and bioanalytical study
- Preparation of customized analytical report ready for regulatory submission
Advantages
- DCGI approved facility
- Expertise in development of methods for various types of analyses (HPLC/UPLC/LC-MS/MS analysis of small molecules/peptides/enantiomers)
- Flexibility in terms of services offered: Bioanalytical alone or as part of BA/BE/Clinical PK study (Phase I, Phase II)/TDM studies
- Staff who are well-versed on various regulatory audits like ANVISA, WHO, UK MHRA
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