Bioanalytical Laboratory for Large Molecules

Clinigene Bioanalytical Laboratory for large molecules specializes in Immunogenicity and PK  analysis of Biologics such as Monoclonal Antibodies, Recombinant proteins, Enzymes, Biomarkers, Cytokines and Growth Hormones during Drug Development phase (preclinical and clinical).

This state-of-the art laboratory spreads over approximately 10000 sq ft. and has a dedicated team of over 32 experienced personnel including Analytical Scientists and Scientific Managers who have deep expertise in the field of Immunoassays. The Bioanalytical Team has extensive experience in Developing, Transferring and Validating Bioanalytical Methods in support of pre-clinical and clinical studies as per International Regulations. The Scientists regularly interact with globally recognized industry experts in the field of Immunoassays.

The instrumentation platforms and software employed for various Bioanalytical Assays are globally harmonized for easy transfer of methods from other laboratories. Validated Watson Bioanalytical LIMS™ sample and data management software is integrated with critical instruments of the Laboratory.

The quality management system supporting the analysis of clinical and pre-clinical samples at the Bioanalytical Laboratory has been established in compliance with the World Health Organization (WHO) Principles of Good Clinical Laboratory Practice (GCLP) and Organization for Economic Co-operation and Development (OECD) Principles of Good Laboratory Practice (GLP) respectively.

Services provided

• Method Transfer and Validation of Radioactive and Non-Radioactive Immunoassays, Surface Plasmon resonance assays (Label free), Electrochemiluminescence assays, Chemiluminescence assays  and Cell Based assays.
• Immunogenicity assays (Screening, Confirmatory, Titre Assessment, Antibody Isotyping and  Cell Based Neutralizing Antibody Assays)
• Pharmacokinetic/Toxicokinetic assays (including ISR)
• Validation of assays according to International Guidelines and Regulations
• Data table preparation
• QC Process
• QA audited data and reports
• Statistical analysis of Immunogenicity & PK/TK data
• Report writing
• Sample Accessioning
• Inventory of Test drug, Reference drug and Critical Reagents

Techniques

The Bioanalytical Laboratory provides comprehensive Immunoassay techniques to cater to Biologics for all phases of Drug Development.

• Non Radioactive Techniques
  
  

  Meso Scale Discovery® (MSD): The MSD uses Electrochemiluminescence technology for the detection of anti-drug antibodies with high drug tolerance (Immunogenicity) and measurement of the drug (Pharmacokinetics/Toxicokinetics) in various biological matrices; in support of drug development. The technology uses Sulpho-tag labels which emit light upon electrochemical stimulation initiated at the electrode surfaces of multiarray/multisport microplates. MSD supports highly sensitive single measurement as well as multiplexing Immunoassays.

  Surface Plasmon Resonance (SPR): The SPR is a label free technique for the measurement of antigen-antibody reactions in real time. The technique involves immobilization of one component (Ligand) on a surface and measuring its interaction with a second component (Analyte) in solution.

  Enzyme Linked Immunosorbent Assay (ELISA): In the context of Immunogenicity, the ELISA technique selectively detects distinct antibodies produced against a specific biological product or drug, while in Pharmacokinetics/Toxicokinetics context, the ELISA technique selectively measures the concentration of the study drug/s in study samples.

  Advia Centaur Immunoassay System: The automated Immunoassay system is useful in the measurement and monitoring of Therapeutic drugs, markers for Oncology, Cardiovascular function, Anaemia, Infectious & Congenital diseases, Autoimmune diseases and Allergy. The principle is a two-step sandwich immunoassay that employs monoclonal antibodies and detects the Immune complex with high sensitivity using the Chemilumiscence technology

  
  
• Radioactive Techniques
  
  

  Radio-Immuno Assay (RIA): The RIA technique selectively measures the concentration of the study drug in study samples using the specificity of antibody – antigen binding and quantification using radioactivity.

  Radio Immuno Precipitation Assay (RIPA): The RIPA technique selectively and specifically detects distinct antibodies produced against a specific biological product or drug with superior sensitivity. The technique utilizes the specific interaction between a radio iodinated biological product and its antibody using radioactivity as measurement.

  
  
• Cell based Assay Techniques
  
  

  Cell based assays (Radioactive and Non-Radioactive) are employed to understand the functional activity of the protein / biological product. Cell based assays are also useful tools for comparing potencies of similar biological products and for the detection of neutralizing antibodies.

• Instrument & Equipment

  - Meso Scale Discovery:

         - Sector Imager 2400

• ELISA Plate readers:

  - Synergy 2 and Synergy HT: (Biotek) UV, Visible,     Fluorescence
  - Spectramax PLUS^® 384 (Molecular Devices) UV,     Visible
  - Infinite 200 (Tecan) UV, Visible, Fluorescence
    ELISA Plate Washers:
  - Biotek, ELX405

• Beta Counter:

  - Chameleon, VLSC 425-158 (Hidex OY)

• Gamma Counter:

  - Wizard 2, 2470-0020 Automatic (Perkin Elmer)

• Automated Immunoassay System:

  - Advia Centaur Immunoassay System (Siemens)

• Surface Plasmon Resonance:

  - Biacore T-100 (GE Healthcare)

• Water Purification System:

  - Milli-Q Intergral 3 (Millipore)

• Instrument Software:

  - (Validated according to international regulations     including 21 CFR part 11)

• Liquid handling systems:

  - Tecan Genesis Freedom 150/8 workstation Platform

• Ultra Low Temperature Freezers (Thermo scientific and Nuaire) and Refrigerators:

  - connected to Temperature Monitoring Alarm System   Sensaphone)

  
  

Quality Assurance

The Bioanalytical laboratory also has an independent QA team responsible for development, implementation, review and up-gradation of Quality Management System. The dedicated QA team comprising of well trained and experienced personnel handles comprehensive internal QA program to ensure compliance to applicable regulations, guidelines and SOPs.