Bioanalytical Services

Brief Global Overview

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