PharmaNet offers bioanalytical services through our subsidiaries: Anapharm and Taylor Technology. These laboratories support biotechnology development by providing specialized immunogenicity testing for the presence of antibodies to biologic and biosimilar products.
Our FDA-audited immunochemistry facilities offer expert immunogenicity services in a GLP environment. We can develop, optimize and validate:
 Proprietary ELISAs |
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| Project-specific cell-based assays |
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| Project-specific enzyme assays |
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Neutralizing assays to determine whether antibodies are blocking a drug’s mechanism of action |
Our expert scientific staff has experience developing, optimizing, and validating cell-based or enzyme assays that are used for the neutralizing assay step. Our scientists have worked with the FDA to receive approval for neutralizing assays and all of the other listed assays during successful BLA submissions and have brought them into commercial release worldwide.
In addition we can:
| Transfer and validate existing ligand-binding, cell-based, and enzyme assays |
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| Validate commercially available kits |
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| Perform single- and multiplexing assays |
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| Optimize cell-line growth parameters |
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| Maintain cell lines |
Our instrumentation and equipment give us the capability to support full-service immunogenicity testing by providing development or transfer of proprietary ELISAs, cell-based, and enzyme assays. Both high sample throughput and high assay sensitivity are available using multiple-plate readers and Meso-Scale platforms. Surge space is available for scaled-up projects. A cell biology laboratory is available for assays requiring cell lines.
To learn more about immunogenicity testing, click on the link below:
Jean Couture
Bioanalytical Director, Immunochemistry Sector
Mr. Couture has more than 27 years of relevant experience in governmental, academic, and industrial settings, including more than 10 years in contract research at Anapharm. In his current position, he is responsible for the scientific review of all development and validation activities for quantitative immunoassays, immunogenicity and biomarker assays as well as for bioanalysis of preclinical and clinical studies for biosimilars. In previous positions as Assistant Director, R&D Sector, Mr. Couture was responsible for ensuring that validations of all methods used for bioanalysis of pharmaceutical substances were in compliance with GLP regulations (FDA, EMEA, ICH, ANVISA). He holds a bachelor’s degree in chemistry from Laval University, in Quebec, Canada, and has published extensively on analytical methods using various instrumentation (HPLC, GC/MS, LC/MS).
Robert Dodge, PhD
Laboratory Director, Immunochemistry
Dr. Dodge has more than 12 years of experience in the biopharmaceutical and contract research industries. In his current position, he oversees a staff of scientists responsible for the development of assays for drug quantitation, immunogenicity screening, and biomarker detection. Prior to this position, Dr. Dodge was the laboratory director at Princeton Bioanalytical Laboratory. Preceding that position, he was at Bristol-Myers Squibb, most recently as Senior Research Investigator and Bioassay Group Leader in protein therapeutics process development. At BMS, his group was responsible for developing cell-based bioassays and for product testing. In addition, he wrote portions of regulatory filings as well as interacted with regulatory authorities regarding approval of protein based drugs. Dr. Dodge has a PhD in chemistry and completed an NIH post-doctoral fellowship at Cornell University.
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