Immunogenicity assays

  • Development and Validation of Method according to EMEA and FDA guidelines.
  • Analysis of Samples in GLP controlledenvironment.
  • Development and validation of Method for Neutralizing Antibodies.
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Generation of Monoclonal Antibodies(Mab’s)

  • Development of Monoclonal and polyclonal Antibodies.
  • We Take development of high Quality antibodies against therapeutic Proteins, Peptides and Small Molecules.
  • Development and validation of Method for Neutralizing Antibodies.
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Pharmacokinetic Assays

We have industry leading experience in development and validation of PK/TK assay for large molecules and peptides.

  • Develop and validate assays that have analytical ranges which appropriate for the study samples.
  • Develop assay that are both specific and sensitive.
  • Provide support for critical reagent generation and purification including the generation of antibodies to be used for capture and detection reagents.
  • Assess method feasibility in multiple technology platforms.

Development and Validation of Host Cell Protein Assay

Host-cell proteins (HCPs) constitute a major part of process-related impurities during biologics production. The amount of residual HCPs in drug product is generally considered a critical quality attribute (CQA), due to their potential to affect product safety and efficacy. Therefore, it is a regulatory requirement to monitor the removal of HCPs in drug product during bioprocess development.

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