Lab Services

Cliantha Research provides scientific expertise with state-of-the-art technologies reinforced by commitment for quality delivery. Our comprehensive lab services include central lab testing, bioanalytical, Pharmacokinetics (PK) services, Immunogenicity (ADA), Bio marker, Vaccine Immunogenicity testing.


  • Bioanalytical
  • IVRT
  • Large Molecule
  • Biomarkers
  • Cell Culture laboratory
  • Vaccine Studies
  • Central Lab

Bioanalytical

Experience

449
Bioanalytical Methods
6
Lacs studies sample per year
162
Professionals

Locations: India & Canada

Expertise & Capabilities:

  • Expert knowledge and experience in conducting bioanalytical assays for unstable compounds, compounds having metabolite back conversion, endogenous compounds, liposomal products, chiral compounds, Elemental analysis.
  • Dedicated teams to ensure that all work is conducted in compliance with SOPs and all applicable regulatory guidelines
  • 449 validated assays compliant with global regulatory agencies. To view assay list Click here
  • Over 5.5 million samples analyzed
  • Highly experienced team involved in MD and MV of simple to complex assays employing most sensitive LC-MS/MS
  • Have capabilities to conduct extensive literature search for difficult assays
  • Analytical prowess for studying the influence of major circulating metabolites in the assay method.
  • Meticulous method developments strategies with experiments covering precision & accuracy and all important stabilities studies.

Infrastructure

  • 38 LC/MS/MS (API 4000, API 5500 & API 6500 equipped with UFLC & HPLCs)
  • One ICP-OES (Thermo iCAP 6300 duo)
  • Separate LC-MS, team and lab set up for dedicated method development and validation
  • Bio repository services: Freezer Storage capacity of more than 1.5 million samples at -20°C and -70°C Temperature

Regulatory Inspection:

Cliantha Research has been successfully inspected or audited by various regulatory agencies across the globe. Our impeccable regulatory track record is the result of strict adherence to the applicable standard(s) and guidelines laid by ICH, FDA, EMA, Clinical and Bio-Analytical bodies. Our enshrined values : Science & Integrity are the foundation for our planning and execution assisted with robust knowledge of the regulations.

To know the audit history click here

IVRT

Cliantha set up an IVRT laboratory in Toronto in May 2018 to conduct IVRT/IVPT method development and method validation studies for monitoring the release of an API from topical dosage forms, generally semisolid formulations such as creams, ointments, gels etc.

Expertise

Developed IVRT Methods:
  • Clobetasol propionate 0.05% cream
  • Clindamycin (1.2%) /Benzoyl peroxide (5%) Gel

Infrastructure

  • Housed on an isolated 1,000 sq. ft. laboratory
  • Complement to the existing 11,000 sq. ft. GLP compliant Bioanalytical Lab Equipped with 2 Hanson Microette 6 cell Diffusion systems for conducting IVRT MD trials
  • Installed Hanson 2 Phoenix DB-6 Diffusion Cell System for conducting IVRT validation and sample analysis trials
  • Have capacity to house up to 6 IVRT Diffusion Cell Systems
  • Currently we have 2 Schimadzu LC-2040C 3D Plus HPLC systems with audit trial
  • Have capacity to house up to 6 HPLC systems Modern Sample Preparation Laboratory Centralized UPS with Back-up Generator
IVRT Methods Under Development:
  • Acyclovir cream
  • Acyclovir ointment
  • Dapsone cream

Large Molecule

Our expert team is involved in developing and validating various ligand binding assays to support large molecule bio analysis. The methodology used for these assays is directly in line with recent FDA and EMA guidance. Some of the many assays for large molecule bio analysis are:

Assay highlights:

  • PK Assays
    • Levothyroxine
    • Erythropoietin
    • Adalimumab
    • Trastuzumab
    • Follicle Stimulating hormone
    • Etanercept
    • Bevacizumab
    • Rituximab and others
  • Immunogenicity Assay
    • Erythropoietin
    • Trastuzumab
    • Adalimumab
    • Bevacizumab and others

Recent validated assay list Click here


Biomarkers

Testing of biomarkers for PHC, neutraceuticals and other related clinical trial studies:

Tools for Pharmacodynamic assessment
Biomarkers are increasingly used to assess the effects of new drugs and therapeutic biological products in patient populations. Because of the important roles biomarkers can play in evaluating the safety, activity, or effectiveness of a new medical product, it is critical to ensure the integrity of the data generated by assays used to measure them. Successful biomarker method validation and bio-analysis is key to new product development. Our team of scientists possess enough skills and experience to perform biomarker method validation using a fit-to-purpose approach as well as drug analysis based validation approach.

Today pharmacodynamic biomarkers are widely used for elaborating optimal dosing of new drugs. We have ELISA , Chemiluminescence microparticle immunoassay (CMIA), flow Cytometry , clot based and chromogenic based platforms to offer robust assays for measurement of pharmacodynamic parameters.

The lab provides comprehensive support in validation and analysis of wide range of biomarkers for PHC, neutraceuticals and other related clinical trials. The lab has a wide range of validated biomarker methods to support a for mentioned studies.

  • Ghrelin
  • Adiponectin
  • Leptin
  • Acetylcholine
  • Epinephrine
  • Human Immunoglobulin G, A, M
  • Hb, Hct, RBC count
  • Nor Epinephrine
  • Malondialdehyde
  • Dopamine
  • Isoprostane
  • Low molecular weight heparin (anti factor IIa and anti factor Xa, TFPI)
  • CD 19
  • Melatonin
  • Super oxide dismutase
  • Oxidized LDL
  • Nitrotyrosine
  • IGF-1
  • CD 34
  • Serotonin
  • MCP-1
  • Klotho protein
  • Catalase
  • hGH
  • Reticulocyte count(% and absolute)

Sample Management:

  • Dedicated and trained sample custodian
  • Three -70°C freezer, one -20°C freezer
  • Regulated temperature monitoring system

Cell Culture laboratory

The large molecule bio-analytical lab also includes a well equipped state-of-the-art cell culture laboratory to provide full support for large molecule bio-analysis. This cell culture lab set up enables thorough evaluation of neutralizing anti drug antibodies using cell based assays. The cell culture lab also supports various other cell based assays key to new product development. Such assays include cell cytotoxicity assay, cell viability assay, cell proliferation assay etc. Potency assay or functional bioassay for drug is one of major requirements for new drug development.

  • State-of-the-art equipments
  • UV light provision for lab sterilization
  • Separate area for autoclave and hot-air oven
  • Pass-box facility for transfer of materials to the lab

Instruments:

  • Microplate reader with absorbance, luminescence and fluorescence features (Spectramax iD3)
  • Bio-safety cabinet (ESCO, 6Ft)
  • CO2 incubators (Thermo Scientific Steri-cycle i160)
  • Inverted microscope with LED-fluorescent attachment and camera (Zeiss Axio Vert. A1 FL-LED)
  • Liquid nitrogen biocanister (Thermo Scientific, 20L)
  • Ultra-low freezer (Eppendorf, -70oC)
  • Refrigerator (Celfrost)
  • Refrigerating Centrifuge (Thermo Scientific)
  • Semi-micro weigh balance
  • Constant temperature water-bath
  • Autoclave
  • Hot-air oven

Vaccine Studies

Clinical development of vaccines requires a specific set of specialized assays to demonstrate the immunogenicity of the vaccine. Ideally, these assays should measure immune responses that correlate with protection against disease. Developing assays for new-generation vaccines usually requires working with cells, pathogens, antigens or assay controls that are not readily available. Validation of these assays involve many challenges as validation requirements are not yet fully specified in regulatory guidelines or White Papers. Our large molecule team has demonstrated experience in conducting numerous CT vaccine studies.

Our vaccine experience includes method validation and sample analysis for

  • Measles virus IgG
  • Mumps virus IgG
  • Rubella virus IgG
  • Diphtheria toxoid IgG
  • Bordetella Pertusis IgG
  • Tetanus toxoid IgG
  • Varicella zoster IgG
  • Haemophilus influenzae type B IgG
  • Anti hepatitis B surface antigen (HBs) IgG
  • Anti-S Typhi Vi IgG
  • Influenza virus H1N1, H3N2 and Type B-10 Brisbane, Type B-12 Massachusetts IgG detection done by haemagglutination and haemagglutination inhibition method.

Technology platforms for vaccine analysis,

  • ELISA
  • Chemiluminescent microparticle immune assay(CMIA)
  • Cell culture

Biomarkers

Testing of biomarkers for PHC, neutraceuticals and other related clinical trial studies:

Tools for Pharmacodynamic assessment
Biomarkers are increasingly used to assess the effects of new drugs and therapeutic biological products in patient populations. Because of the important roles biomarkers can play in evaluating the safety, activity, or effectiveness of a new medical product, it is critical to ensure the integrity of the data generated by assays used to measure them. Successful biomarker method validation and bio-analysis is key to new product development. Our team of scientists possess enough skills and experience to perform biomarker method validation using a fit-to-purpose approach as well as drug analysis based validation approach.

Today pharmacodynamic biomarkers are widely used for elaborating optimal dosing of new drugs. We have ELISA , Chemiluminescence microparticle immunoassay (CMIA), flow Cytometry , clot based and chromogenic based platforms to offer robust assays for measurement of pharmacodynamic parameters.

The lab provides comprehensive support in validation and analysis of wide range of biomarkers for PHC, neutraceuticals and other related clinical trials. The lab has a wide range of validated biomarker methods to support a for mentioned studies.

  • Ghrelin
  • Adiponectin
  • Leptin
  • Acetylcholine
  • Epinephrine
  • Human Immunoglobulin G, A, M
  • Hb, Hct, RBC count
  • Nor Epinephrine
  • Malondialdehyde
  • Dopamine
  • Isoprostane
  • Low molecular weight heparin (anti factor IIa and anti factor Xa, TFPI)
  • CD 19
  • Melatonin
  • Super oxide dismutase
  • Oxidized LDL
  • Nitrotyrosine
  • IGF-1
  • CD 34
  • Serotonin
  • MCP-1
  • Klotho protein
  • Catalase
  • hGH
  • Reticulocyte count(% and absolute)

Sample Management:

  • Dedicated and trained sample custodian
  • Three -70°C freezer, one -20°C freezer
  • Regulated temperature monitoring system

Cell Culture laboratory

The large molecule bio-analytical lab also includes a well equipped state-of-the-art cell culture laboratory to provide full support for large molecule bio-analysis. This cell culture lab set up enables thorough evaluation of neutralizing anti drug antibodies using cell based assays. The cell culture lab also supports various other cell based assays key to new product development. Such assays include cell cytotoxicity assay, cell viability assay, cell proliferation assay etc. Potency assay or functional bioassay for drug is one of major requirements for new drug development.

  • State-of-the-art equipments
  • UV light provision for lab sterilization
  • Separate area for autoclave and hot-air oven
  • Pass-box facility for transfer of materials to the lab

Instruments:

  • Microplate reader with absorbance, luminescence and fluorescence features (Spectramax iD3)
  • Bio-safety cabinet (ESCO, 6Ft)
  • CO2 incubators (Thermo Scientific Steri-cycle i160)
  • Inverted microscope with LED-fluorescent attachment and camera (Zeiss Axio Vert. A1 FL-LED)
  • Liquid nitrogen biocanister (Thermo Scientific, 20L)
  • Ultra-low freezer (Eppendorf, -70oC)
  • Refrigerator (Celfrost)
  • Refrigerating Centrifuge (Thermo Scientific)
  • Semi-micro weigh balance
  • Constant temperature water-bath
  • Autoclave
  • Hot-air oven

Vaccine Studies

Clinical development of vaccines requires a specific set of specialized assays to demonstrate the immunogenicity of the vaccine. Ideally, these assays should measure immune responses that correlate with protection against disease. Developing assays for new-generation vaccines usually requires working with cells, pathogens, antigens or assay controls that are not readily available. Validation of these assays involve many challenges as validation requirements are not yet fully specified in regulatory guidelines or White Papers. Our large molecule team has demonstrated experience in conducting numerous CT vaccine studies.

Our vaccine experience includes method validation and sample analysis for

  • Measles virus IgG
  • Mumps virus IgG
  • Rubella virus IgG
  • Diphtheria toxoid IgG
  • Bordetella Pertusis IgG
  • Tetanus toxoid IgG
  • Varicella zoster IgG
  • Haemophilus influenzae type B IgG
  • Anti hepatitis B surface antigen (HBs) IgG
  • Anti-S Typhi Vi IgG
  • Influenza virus H1N1, H3N2 and Type B-10 Brisbane, Type B-12 Massachusetts IgG detection done by haemagglutination and haemagglutination inhibition method.

Technology platforms for vaccine analysis,

  • ELISA
  • Chemiluminescent microparticle immune assay(CMIA)
  • Cell culture

Central Lab

Experience & Expertise

With 14 years of therapeutic expertise & scientific knowledge, Cliantha strictly abides by the quality parameters required for clinical testing. We continuously update & validate our new test methods & appraise industry trends to enhance our capabilities.

Performing more than 200 lab tests varying from routine safety to speciality testing. Our capabilities include

  • Auto-Immune Profiles
  • Biochemistry
  • Biomarkers – Cytokines And Growth Factors
  • Coagulation Studies
  • Diabetic Profiles
  • Drug Screening
  • Endocrinology Testing
  • Flow Cytometry Assays
  • Hematology
  • Immune Function Assays (Elispot)
  • Infectious Disease Serology
  • Inflammatory Disease/Immune Markers
  • Lipid Profiles
  • Serum Proteins
  • Technology Transfers
  • Urinalysis
Sr.No. Discipline/Methodology  
1 Autoimmune/Inflammatory/Allergy Rheumatoid factor Free light chains
Autoantibodies
Complement Interleukins
Interferon Serum IgE,G,M,A
2 Cell-based Assays/Flow Cytometry PBMCs Cell enumeration
Immune response Cell surface assays
CD markers 
3 Chemistry/Immunoassay Bone markers Cardiac markers
Diabetes Drugs of abuse
Toxicology Oncology
Endocrinology Routine chemistry
Metabolic diseases Liver function
Infectious diseases
4 Hematology/Coagulation Clotting time studies Factor evaluations
D-dimer CBC and differential
5 Hormones and proteins C-reactive protien
HDL,LDL,VLDL and ratios
Triglycerides
Acetylcholine,Dopamine,Epinephrine, Norepinephrine,5HT,melatonin,malondialdehyde,3-nitrotyrosine,isoprostane, Superoxide dismutase -1, human MCP-1
6 Urinalysis Dipstick testing (ketone, protien, bilirubin etc.)

Our Accreditations: A Proven Track Record

Cliantha Research Central Lab facilities adhere to the principles of GCLP & are accredited by

  • The College of American Pathologists (CAP) at Ahmedabad, Vadodara & Noida
  • National Accreditation Board for Testing and Calibration Laboratories (NABL) at Ahmedabad

To know the accrediation history click here


Services offered

Central Reference Laboratory, Ahmedabad is equipped with the State-of-the-art technology to ensure that we deliver precise and accurate laboratory results within the shortest possible turn around time. The laboratory provides a range of comprehensive services including customized specimen transfer kits, customized test requisition forms, protocol specific collection manual, and bar-coding of samples. The laboratory also has the capability of long term specimen archival with complete identity protection and audit trail at each and every step.

  • All facilities compliant with CAP standards.
  • Fully implemented GCLP Practices
  • Stringent internal quality control.
  • External Proficiency Testing Program from CAP and BIO-RAD.
  • Total Quality Management System.
  • An automated system from bar coding to bi-lateral interfacing of results to minimize any kind of clerical error.
  • Training of investigators at clinical trials sites through customised power point presentations demonstrating venipuncture ,sample labelling and packaging.

Facilities available:

  • Bar Coding of each sample
  • Compact high performance 5- Part differential hematology analyzer
  • Fully automated discreet, random access, continuous loading, microprocessor controlled integrated Chemistry and Immunology System
  • Fully automated coagulation analyzer
  • Flow cytometry
  • Direct interfacing of the instrument with LIS with no manual intervention

Logistics Network:

  • Managing more than 50+ sites across India
  • Coordinating with 12000+ shipments annually
  • Efficient logistics network with flexible solution catering local requirements
  • Cold chain maintenance

Acess To Real Time Data (Web based reporting)

The laboratory also has a web Based Report Viewer is a highly secure Web-based tool enabling real-time review of laboratory reports in PDF format, which can be printed or saved for future reference Laboratory reports get uploaded on to our web site on a real time basis, thus reducing the time of report delivery by other means

  • Unique Username & password generation to view study specific reports
  • Real time upload of Reports.

Laboratory Information Management System

Central Reference Laboratory has a state of the art Centralized Laboratory Information Management System.

  • All instruments have been interfaced bi-directionally or uni-directionally depending on the analyzer's capability for better accuracy and faster reporting