In Biologics and Biosimilars

PharmaNet Development Group offers a full range of services relevant to the clinical development of large-molecule products, including both branded and generic products. Our services include clinical development, consulting, and bioanalysis by laboratories with cutting-edge experience in large molecules.

Cell-based Assay

PharmaNet supports the development of biologics and biosimilars by providing cell-based assay services through its subsidiary, Taylor Technology. Our expert scientific staff has experience bringing biologics to market and our cell-biology laboratories can:

 

Develop and optimize cell-based assays
Validate cell-based assays
Optimize and maintain customized cell lines

 

Applications for these cell-based assays include:

 

Immunogenicity testing for large-molecule products
Biomarkers for small- or large-molecule drugs
Laboratory evaluation of vaccine efficacy
Biologic potency testing

 

Our scientists are experienced in obtaining approval for assays during BLA negotiations with the FDA and transferring these assays to commercial facilities worldwide. Our cell-biology instrumentation complements our immunochemistry capabilities and enables us to offer full-service assay development and sample testing.

 

 

Example of a Bioassay

In this example of a monoclonal antibody acting on a T cell, the drug binds to a receptor and triggers downstream events that can be confirmed by measuring IL-4.

 

PharmaNet Development Group, Inc.504 Carnegie Center, Princeton, NJ 08540Tel 609 951 6800Fax 609 514 0390