Lab Services

Bioanalytical

Experience

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

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Infrastructure

• 47 LC/MS/MS (30 API 4000, 4 API 6500+, 9 API 5500, 2 Sciex 7500, 2 Shimadzu 8060NX equipped with UFLC & HPLCs)
• 1 ICP-MS lab
  2 ICP-MS ( Thermo Scientific iCAP-RQ)
• Separate LC-MS, team and lab set up for dedicated method development and validation
• Bio repository services: Freezer Storage capacity of more than 2.0 million samples at -20°C and -70°C Temperature

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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

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Cliantha Unique capabilities

Fully validated,21 CFR Part 11 compliant in-house developed web based application.

Salient features

• A web based system to manage application modules which are used in bioanalytical lab.
• CLIMS is compliant with operational & functional requirements of Cliantha Research and regulatory requirements i.e. system access, electronic record storage, review, integrity, security, reliability and audit trails in closed system environment.
• Initially, CLIMS consist of Admin Module and Doc-Review Module, but not limited to this. Many more modules are on the way and under development to fulfill day to day requirement of bioanalytical lab.

Admin Module

• Admin Module provides common user management to all modules which will be developed and attached with CLIMS.
• All modules will be internally linked with the Admin module to manage module wise access of each individual user with their respective functional role.
• User management is becomes easier with hierarchical role management.

Doc-Review

• Provides secure and electronic platform for storing printouts in PDF format generated through CDS and other supporting activities in lab.
• Provides electronic data reviewing to user within lab as well as other department like QA/QC too.
• Reduces paper from lab and provides digital platform.
• Assigning unique document ID to each uploaded document.
• Real time tracking of data within the departments.
• Each action is audit trailed and validations provide integrity to data.
• Dynamic reports and dashboard makes life easier for managing and planning of routine work.

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.

Services:

• Pharmacokinetics
• Pharmacodynamics
• Anti-drug antibody assays
• Neutralizing antibody assays
• In-vitro studies

Strengths:

• Customized method development considering patient demographics, region wise regulatory requirements, mechanism of action and nature of therapeutic drugs.
• Qualified and skilled personnel with an average 10+ years of experience
• GCLP compliance Sample management and critical reagent lifecycle management system.
• SOP driven validation, US FDA 21 CFR part 11 compliant systems

Technologies

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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

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Cell Based Assays

Cliantha has well equipped Biosafety level 2 (BSL-II) state-of-the-art cell culture laboratory to provide full support for large molecule bio-analysis including neutralizing antibody assay, In-vitro assays and vaccine immunogenicity.

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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.

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Vaccine Studies

Cliantha has well equipped state of art analytical facility to provide NABL accredited vaccine immunogenicity services for regulatory submissions. Our lab has analyzed 25000+ samples from 4000+ subjects from attenuated (live) vaccines, inactivated vaccines, toxoid vaccines and conjugate vaccines

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 Biosafety level 2 (BSL-II) state-of-the-art cell culture laboratory to provide full support for large molecule bio-analysis including neutralizing antibody assay, In-vitro assays and vaccine immunogenicity.

• 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

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Flow Cytometry Solutions

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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