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Testing Services for Large Molecule Drug Development

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Immunogenecity, Pharmacokinetics, Biosimilars & Biomarkers

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Eurofins Pharma Bioanalytical Outsourcing Partner of Choice 

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Guidance Documents

 

 

 
 
Bioanalytical Method Validation

HHS, FDA, CDER, CVM


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Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products
HHS, FDA, CDER, CBER, CDRH


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Guideline on Immunogenicity assessment of biotechnology-derived therapeutic proteins
European Medicines Agency


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Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product
HHS, FDA, CDER, CBER


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Scientific Considerations in Demonstrating Biosimilarity to a Reference Product
HHS, FDA, CDER, CBER


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Posters

 

 

Challenges in the Transfer of Complex Assay Formats

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Development of Method for Detection of Anti-Drug Antibodies to Bevacizumab in the Presence of Soluble VEGF

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Development and Qualification of PK and ADA Methods for Biosimilar Trastuzumab

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Overcoming Challenges for Flow Cytometry in Clinical Regulated Biomarker Analysis

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Phenotypic Characterization of Leucine-rich Repeat Kinase 2 (LRRK2) Knockout Rat Model: A Multi Parameter Cross Platform Biomarker Study

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Validating Flow Cytometry Assays for Use During Clinical Trial Biomarker Assessments

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Recommendations for Demonstrating Equivalency of Ready to Assay Cells in Neutralizing Antibody (NAb) Methods Post-Validation

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Immunogenicity analysis: Challenges and Solutions for PEGylated Biopharmaceuticals

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A Quick and Efficient Approach to Immunogenicity Assay Development and Optimization using Design of Experiments

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Novel Approach to Immunogenicity Testing for Therapeutics with High Prevalence of Pre-Existing Antibodies

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Development and Qualification of PK and ADA Methods for Biosimilar Trastuzumab

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GLP Validation of a Gyrolab® Assay for the Determination of Interleukin 8 (IL-8) Levels in Cynomolgus Monkey Serum

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Videos

 An interview with Jim Hulse, PhD - Senior Vice President of Business Development
  

Large Molecule Bioanalysis Scientific Consulting 

 


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