Immunogenicity assays

• Development and Validation of Method according to EMEA and FDA guidelines.
• Analysis of Samples in GLP controlled environment.
• Development and validation of Method for Neutralizing Antibodies.

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.

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.