Global Leader in Biologics-focused Bioanalytical Solutions
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Full-Service Biomarker Assay Development
Global, comprehensive Bioanalytical and Biomarker Services
Validated Multiplex Quantitation of Human Cytokines
Testing Services for Large Molecule Drug Development
Immunogenicity, Pharmacokinetics, Biosimilars & Biomarkers
Eurofins Pharma Bioanalytical Outsourcing Partner of Choice
Successful Cell-based ADA Collaboration in mRNA Gene Replacement Therapy - Reducing Time and Variability
Delivering Flexibility in a Multi-site Global Harmonized Clinical Trial
A Clinical Sample Receptor Occupancy Assay Using Flow Cytometry
Method Transfer and Optimization of a Flow Cytometry Method Following Best Practice in a Regulated Environment
Bioanalytical Method Validation HHS, FDA, CDER, CVM
Immunogenicity Testing of Therapeutic Protein Products —Developing and Validating Assays for Anti-Drug Antibody Detection
Guideline on Immunogenicity assessment of biotechnology-derived therapeutic proteins European Medicines Agency
Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product HHS, FDA, CDER, CBER
Scientific Considerations in Demonstrating Biosimilarity to a Reference Product HHS, FDA, CDER, CBER
Development & Validation of Novel ECL Method for Detection of Complement C3
Development & Validation of a PK Assay for a Biparatopic Ab (2023 WRIB)
Challenges in the Transfer of Complex Assay Formats
Development of Method for Detection of Anti-Drug Antibodies to Bevacizumab in the Presence of Soluble VEGF
Overcoming Challenges for Flow Cytometry in Clinical Regulated Biomarker Analysis
Phenotypic Characterization of Leucine-rich Repeat Kinase 2 (LRRK2) Knockout Rat Model: A Multi Parameter Cross Platform Biomarker Study
Validating Flow Cytometry Assays for Use During Clinical Trial Biomarker Assessments
Recommendations for Demonstrating Equivalency of Ready to Assay Cells in Neutralizing Antibody (NAb) Methods Post-Validation
Immunogenicity analysis: Challenges and Solutions for PEGylated Biopharmaceuticals
A Quick and Efficient Approach to Immunogenicity Assay Development and Optimization using Design of Experiments
Novel Approach to Immunogenicity Testing for Therapeutics with High Prevalence of Pre-Existing Antibodies
Development and Qualification of PK and ADA Methods for Biosimilar Trastuzumab
GLP Validation of a Gyrolab® Assay for the Determination of Interleukin 8 (IL-8) Levels in Cynomolgus Monkey Serum
Strategies for Bioanalytical Method Development & Validation
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2024 AAPS Journal White Paper: qPCR & dPCR Method Development and Validation
Roadmap to Successful Drug Therapy Partnerships
Critical Reagent Management Strategies to Ensure Method Performance while Reducing Timelines and Cost
Overcoming Effects of Interfering Factors in Cell-based NAb Methods
Streamline your SARS-CoV-2 Antibody Testing with a sVNT NAb Solution
Rare Event Analysis in Flow Cytometry: Design Control and Validation Aligned with CLSI H62
Accelerate Your COVID-19 Bioanalytical Therapeutic and Vaccine Research While Saving Time and Reducing Cost
PBMC Harmonization in Multi-Site Global Clinical Trials: Challenges & Solutions
Biosimilar Development: Recommendations to Support Informed Decision Making Earlier in Your Pipeline
Applications of Flow Cytometry in the Drug Development Process
Matrix Interference in Ligand-Binding Assays: Modern Solutions to an Established Analytical Problem
Multiparameter Flow Cytometry Applications and Future Outlook
Considerations for Ligand Binding Assay Platforms: How to Choose the Right Platform to Meet Your Drug Development Needs
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