‘ClinSync Bioanalytical facility is aimed to provide high quality, cost-effective sourcing solution for the analysis of PK and PD samples coming from preclinical and clinical studies conducted in entire Globe’
• State of Art set up with independent access-controlled Deep freezer area, Balancing room (Sartorius), sample processing area and instrumentation area.
• Small molecules LC/MS/MS – using mass spectrometric techniques
• 2 Triple Quadrupoles Mass Spec (2 ABSciex API 4000)
• Have capacity to handle approx 3000-4000 samples per month
• Large Molecules – using ligand binding assay techniques (through partner channel)
• Initiated operations in Dec 2014
• Completed the MD and MV of Niverapine and MD of Pramipexole (MV expected to be ready by Feb 05)
• Rapid assay development, validation, sample analysis
• Supporting a full range of development from Preclinical to Late Stage Clinical programs
• Central Lab Services for clinical PK studies: Sample Logistics / Sample Repository / Preparation and Distribution of Sampling Kits
• Core team of bio-analytical personnel having experience of handling critical molecules such as ethinyl estradiol, gestidine and prostidine
• Complete back up for the LC/MS to aid any system break downs
• SOPs and Bio-analytical method validation (including Incurred Sample Re-analysis) in compliance to US-FDA and EMEA guidance
Brief Global Overview
• Developing and Validating Bio-analytical Methods involving
• Drug and Metabolite from same Sample
• Multiple Analytes in same Sample
• Highly Sensitive Methods with detection as low as pg/mL
• Can quantify even with low sample volume (nearly 0.1 mL)
• Extraction procedures include protein precipitation, liquid-liquid extraction, solid phase extraction.
• Use of 17.2 Mega ohm water for all analytical processing and chromatographical methods.
• Collaborations with logistical vendors across the globe like World Courier and PDP to successfully handle sample receipt from various locations within India, across US, Europe and China to support multi-national and multi-centric trials.
• Can handle different matrices like Plasma, Blood, Brain homogenates, Cerebro Spinal Fluid, Urine, Feces, any hard tissue (colon, spleen etc), Microsomes, Bile, Isolated Brain Regions, Assay Buffers
• PK Study with 1500 samples
• Preliminary Data within 2 weeks from sample receipt (for discovery side)
• Audited Data within 2 weeks of last sample analysis
• 48 hour turnaround, if needed for dose range/escalation study
Small Molecule LC-MS/MS
• Bioanalytical Method Development & Validation
• Sample Analysis for different evaluation purposes:
• Pharmacokinetic (PK) screening
• Toxicokinetic (TK) studies
• Clinical PK/Bioavailability studies
• Bioequivalency studies
• Therapeutic drug monitoring studies
• Biomarker studies
• Drug-drug interaction studies
• Sample Analysis of different compound structures:
• Oligonucleotides Analysis
• Peptide Analysis
• Sample Analysis in different biological matrices:
• Dried Blood Spots
• Tissues
Oncology
HIV/ TB/ Malaria/ Hepatitis and other infectious conditions
Post menopausal women
Dermatology- Transdermal patches, Gel/ Foam/ Cream, Cumulative Irritation studies & Skin sensitization studies
Hepatic Impairment
Renal Impairment (at partner Kidney Center)
Hypogonadal studies
Contraceptive studies
Cardiovascular and Metabolic Diseases- Cardiac Failure & Diabetes