‘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