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
  • Immunoanalytics
  • Biomarkers
  • Cell Based Assays
  • Vaccine Studies
  • Central Lab
  • Microbiology

Bioanalytical

Experience

612
Bioanalytical Methods
6
Lacs studies sample per year

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
  • 600+ validated assays compliant with global regulatory agencies. To view assay list Click here
  • Over 6 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


Cliantha Unique capabilities

Colmtrack

Fully validated, 21 CFR compliant in-house developed and web based application

Salient features

  • Fully validated to meet 21 CFR Part 11 compliance
  • A complete web based system for all of column management needs
  • Captures end to end information – procurement, reservation, washing, tracking and up to disposal
  • Real time tracking of columns ensuring no missing column
  • Get all the information – Certificate, column care, usage history, age, current location, reservation status accessible from any location any system
  • Analytics to help the user while ordering columns
  • First of its kind in the entire industry
  • Each action is audit trailed
  • Automatic ID and controlled label generation
  • Integrated library for Column washing & regeneration procedures
  • Intuitive washing time calculator with washing detail manager
  • Different menu options for column selection based on application MD, MV, study
  • With information/help section on each step to guide for end users and external auditors in accordance with in house SOPs
  • User management and User rights distribution for System Access Control

IAM

  • Instrument activity manager (IAM) is a central system for tracking all the lab activities which are performed at regular frequency like Calibration, preventive maintenance and related activities

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

Immunoanalytics

Cliantha’s Large Molecules laboratory has been dedicated to helping clients advance their research programs by providing high quality, accurate results for biosimilar development. Large Molecule lab is specialized in pharmacokinetics & immunogenicity studies and has extensive experience in working with therapeutic monoclonal antibodies, recombinant proteins and hormones to support global clinical trials.

Services:

  • Method development/ transfer of ELISA, Clot based assays and Chemiluminescent microparticle based assays for Pharmacokinetic analysis of Large molecule Biologics or Biosimilars
  • Multi-tiered Immunogenicity assays including screening, confirmatory, titer & NAB assessment
  • Cell based (CBA) & Competitive Ligand Binding (CLB) Neutralizing antibody assays
  • Conducting method validation as per international guidelines and regulations & good practices (GXP)
  • Sample preparation, storage, logistics, tracking, archival and management
  • Statistical analysis of Immunogenicity and PK data
  • Lab Manuals, Report writing & data archival
  • Labelling of antibodies and critical reagent life cycle management

Strengths:

  • Expertise in immunoassay development, validation and large scale sample analysis as per regulatory guidelines.
  • Wide range of assay formats and instrumentations.
  • Project teams with expertise in the areas of immunogenicity, PK studies and PD studies.
  • Experienced personnel trained in GLP/GCLP.
  • Dedicated teams for sample management, quality control and quality assurance.
  • USFDA 21 CFR part 11 compliant electronic records and signatures.

Recent validated assay list Click here


Biomarkers

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

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.

Cliantha has developed a wide biomarker portfolio which includes over 100+ biomarkers spanning a diverse range of disease states. Cliantha works closely with clients to shape their biomarker strategy and selecting the best analytical technology by:

  • Identifying the appropriate biomarker
  • Selecting the right regulatory approach for compliance
  • Conducting fit for purpose method validation to support clinical trials
  • Choose the best analytical methodology

Cell Based Assays

Cliantha has 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, Enzyme inhibition assays, cell signaling assay etc.


Strengths:

  • Experienced team from development, discovery & regulated background
  • Regulated process to prepare master cell bank, working cell bank
  • Dedicated teams for sample management, quality control and quality assurance.
  • GCCP, GLP & GCLP compliance system & process
  • US FDA 21 CFR part 11 compliant electronic records and signatures.

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:

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.

Cliantha has developed a wide biomarker portfolio which includes over 100+ biomarkers spanning a diverse range of disease states. Cliantha works closely with clients to shape their biomarker strategy and selecting the best analytical technology by:

  • Identifying the appropriate biomarker
  • Selecting the right regulatory approach for compliance
  • Conducting fit for purpose method validation to support clinical trials
  • Choose the best analytical methodology

Cell Based Assays

Cliantha has 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, Enzyme inhibition assays, cell signaling assay etc.


Strengths:

  • Experienced team from development, discovery & regulated background
  • Regulated process to prepare master cell bank, working cell bank
  • Dedicated teams for sample management, quality control and quality assurance.
  • GCCP, GLP & GCLP compliance system & process
  • US FDA 21 CFR part 11 compliant electronic records and signatures.

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

Clinical Laboratory Services and Central Reference Lab

  • 3 CAP accredited central lab facilities
  • Experience from over 3000 clinical trials
  • 1 million results reported
  • Greater than 99.5% reportable tests
  • Clinical Laboratories provide world-class scientific expertise with state-of-the-art technologies supported by a commitment to exceptional quality.
  • Being a CAP and NABL accredited laboratory for many years, the labs have created a benchmark in quality.
  • The labs have aligned technology platforms and global SOPs to provide consistent and combinable data.
  • Cliantha offers Central Laboratory Services to support the needs of drug development for various Phases of Clinical Trials. Our service capabilities extend to support Multicentric Clinical Trials with sites in India as well in other countries.

Services


Comprehensive Tests


Flow Cytometry Solutions

  • We have comprehensive flow cytometry solutions to support all phases of drug development.
  • Laser focused capabilities
  • Cliantha offers
    • Comprehensive menu of supporting translational biomarker development solutions including diagnostic flow cytometry services
    • Solutions for complex clinical challenges with fit for purpose, customized flow assays.

Key Strengths – Clinical Trials

Microbiology

Microbiology Lab Capabilities

Cliantha Research offers cost effective microbiology contract research services to companies involved in medical devices and antimicrobial products.

  • We offer efficient and economic antimicrobial agent screening against bacteria, fungi and biofilms.(Viruses and mycobacteria excluded)
  • We test against a wide variety of standard and non-standard(culture collection sourced) microbial strains
  • Disinfectant validation studies against a variety of microorganisms including bacteria, fungi and bacterial endospores
  • Supporting home and personal care products clients with laboratory testing, evaluation, consulting and research activities
  • Microbiology testing for cosmetics
  • Packaging testing
  • Consumer healthcare trials