Bioanalytical Research Laboratory
Bioanalytical Research Laboratory at Clinigene is involved in the analysis of drug(s) and/or active metabolite(s) from biological matrices in support of Bioavailability (BA), Bioequivalence (BE) and Pharmacokinetic (PK) studies. 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 (e.g. blood, plasma, serum, urine, etc.).
With the state-of-the-art equipment including triple quadrupole LC-MS/MS, HPLC with PDA, UV and Fluorescence detectors, the laboratory provides services to meet the outsourcing needs of sponsors, especially with regard to quality and timelines. With its highly skilled and experienced researchers, the laboratory possesses competency in development, validation and transfer of the bioanalytical method.
Our functions follow the GLP principles with comprehensive SOPs implemented for various activities in the laboratory. Each activity is closely monitored by the QA personnel for compliance as per the national and international regulatory requirements. At Clinigene, we are committed to provide quality bioanalytical services with 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) with ESI and APCI sources
• HPLC (Waters Alliance, 2 nos) with separation module and PDA/dual wavelength/Fluorescence detectors
• Software
- Analyst 1.4 and above (LC-MS/MS) and MetID
- Empower 1.0 (HPLC)
- Watson 7.3 (Laboratory Information Management System)
- Nugenesis 7.0 (Scientific Data Management System)
• Pharmacokinetic Analysis – WinNonlin Enterprise 5.1
Expertise
- Development of bioanalytical methods for drugs and/or metabolites using LC-MS/MS or HPLC
- Experience in bioanalysis of wide range of drug molecules including peptides
- Bioanalytical report preparation and review
- Bioanalysis to support BA, BE, PK, Phase I, Phase II and TDM studies
Services
- Development and validation of bioanalytical methods for analysis of drug(s) and/ or active metabolite(s) in biological matrices
- 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 application of the method for analysis of study samples
- Preparation of customized analytical report ready for regulatory submission
- Development, validation and application of method for clinical PK (including Phase I/Phase II)/TDM studies
Advantages
- DCGI approved facility
- Expertise in development of methods for various types of analyses
- Flexibility in terms of services offered: Bioanalytical alone or as part of BA/BE/PK/ Clinical study
- Experienced staff who have faced various regulatory audits like ANVISA Brazil, WHO, UK MHRA
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