Biosimilars

Biosimilars

Cliantha is a leading provider of Biologic and Biosimilar Research. We offer in the full services clinical development of Biologics and Biosimilars. Our diverse and expert brings with it, hands on experience in Biosimilars development including regulatory support, medical writing and execution of Phase I-IV studies. In support of the studies required, we have experience developing and validating PK, PD and immunogenicity methods. Cliantha has the complete package for Biosimilars.

Regulatory

Our Medical Affairs team in cooperation with our KOLs and clinical, bioanalytical, immunochemistry groups, works with our sponsors to develop comprehensive strategies to approach the regulatory agency of choice. This can be FDA, EMA or other country specific authorities. We develop the clinical program that will best support initial discussions with regulators. After our discussions with regulators, we incorporate the feedback received in the clinical program plan and execute the program.

Phase I:

Cliantha has an experienced team handling Phase I studies (Healthy Volunteers) with Biosimilars. Studies can be conducted at our clinical facility or at hospital sites depending on the complexity of molecule or study design. Expert medical and paramedic staff ensures proper administration of dose supervised by Physicians and safety experts. The team has conducted several Phase I studies in healthy volunteers and understands the importance of safety, dose administration, sample handing and processing.

Laboratory testing:
  • At Cliantha, our expert scientists have the biosimilar experience you need to keep your project on track. The team has a strong commitment to be client focused and flexible. The laboratory combines research and development capabilities to streamline the process of developing and validating an assay. Also, we work closely with sponsors when they are transferring the technology to our laboratory for implementation during the trial.
  • Cliantha has an expert team involved in developing and validating ligand binding assays for macromolecules for PK, PD and immunogenicity studies. The methodology used in the development of these assays is directly in line with the most recent FDA and EMA guidances. They are proficient in the specific challenges that large molecule bioanalysis can bring, particularly in a clinical setting.
The comprehensive lab services span from
  • Large molecule PK
  • Immunogenicity
  • Biomarker assessment and
  • Vaccine testing.
Immunogenicity Testing

We are able to perform immunogenicity testing for antibodies to immunogenic drugs. We deploy a three tiered evaluation approach:

  • Anti-drug antibody screening test
  • Positive ADA confirmation test
  • Titration

Generally, floating cut points are used. Study specific cut points are calculated using baseline samples.

We have capabilities of detecting anti-drug antibodies by
  • Indirect / bridge ELISA
  • Confirmatory Assays using immuno-depletion
We have immunogenicitytesting methods for
  • EPO
  • Bevacizumab
  • GCSF
Vaccine testing

The lab has conducted numerous vaccine studies. Our vaccine experience includes:

  • Tetanus toxoid IgG
  • Measles virus IgG
  • Mumps virus IgG
  • Rubella virus IgG
  • Diphtheria toxoid IgG
  • Varicella zoster IgG
  • BordetellaPertusisIgG
  • Influenza virus H1N1, H3N2 and Type B-10 Brisbane, Type B-12 Massachusetts IgG detection was done by haemagglutination and haemagglutination inhibition method.
Phase II/III

The clinical trials team at Cliantha provides expert clinical management with Biosimilar Clinical Trials. We can plan and run your global clinical trial or conduct the Indian arm of your trial. Our team has completed work successfully for the Indian regulatory authority as well as for FDA and EMA. Our database of more than 400 oncologists and 1500 Investigators in other specialties allows us to achieve the recruitment rate in the best possible times

Immunochemistry

Cliantha offers GLP compliant immunoassays. The bioanalytical services include GLP compliant assays for peptides, proteins, monoclonal antibodies (mAB) under FDA and EMA regulations. We utilize the following platforms:

  • ELISA
  • CMIA
  • Clot based assays
  • Flow Cytometry
We have validated methods for
  • Levothyroxine and
  • Tri - iodo thyronine
  • Erythropoietin
  • Low molecular weight heparin (assessment of its pharmacodynamic parameters)
    • anti – factor IIa
    • anti – factor Xa/li>
We have developed methods for
  • Rituximab
  • Teriparatide
  • Darbaepoeitin
  • Trastuzumab
  • GCSF
  • FSH
  • Peg GSF
Biomarker assay

Being a CAP accredited lab, with FDA and EMA experience puts the lab in a unique position to cater to the needs of biomarker assessments.

Assay platforms:

ELISA, Flow Cytometry, ECLIA, CMIA, end point assays, kinetic assays, clot based assays

Our expertise spans the therapeutic spectrum and includes the markers for:

  • Oncology
  • Autoimmune diseases
  • CVS
  • CNS
  • Metabolic disorders
Accomplishments

The team has been regularly presenting at international conferences –

Poster titled "Challenges in estimation of FSH for pharmacokinetic study by Architect i1000 (CMIA based clinical lab instrument)and commercial kitss" which won the best poster award at the 10th WRIB at Orlando in Apr’16.

Poster titled "An acid dissociation Bridging ADA assay for immunogenicity assessment of Bevacizumab" in Annual Immunogenicity and Bioassay summit held in Baltimore, MD, USA, Nov 15.

Poster titled 'ELISA assay for determination of bevacizumab (pharmacokinetic) VEGF– A (pharmacodynamic), and immunogenicity assessment' at the 9th WRIB (Workshop on Recent Issues in Bioanalysis) in Miami, Florida in Apr '15.

For a list of current assays, click here

Regulatory Inspections

Last Inspection in Nov 2015
Inspected facility in Nov 2006
Inspected facility in Jan 2009
Last inspection in Apr-May 2016
Inspected facility in Feb - Mar 2013
Last inspection in March 2013
Inspected facility in July 2013
Last inspected by Ministry of Health of Turkey in April 2013
Last inspection in Apr-May 2016