Scientific Resources

Case Studies

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 OccupancyAssay Using Flow Cytometry

Method Transfer and Optimization of aFlow Cytometry Method Following BestPractice in a Regulated Environment


Bioanalytical Method Validation HHS, FDA, CDER, CVM Download	Immunogenicity Testing of Therapeutic Protein Products —Developing and Validating Assays for Anti-Drug Antibody Detection Download	Guideline on Immunogenicity assessment of biotechnology-derived therapeutic proteins European Medicines Agency Download

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


Challenges in the Transfer of Complex Assay Formats Download	Development of Method for Detection of Anti-Drug Antibodies to Bevacizumab in the Presence of Soluble VEGF Download	Development and Qualification of PK and ADA Methods for Biosimilar Trastuzumab Download	Overcoming Challenges for Flow Cytometry in Clinical Regulated Biomarker Analysis Download

Phenotypic Characterization of Leucine-rich Repeat Kinase 2 (LRRK2) Knockout Rat Model: A Multi Parameter Cross Platform Biomarker Study Download	Validating Flow Cytometry Assays for Use During Clinical Trial Biomarker Assessments Download	Recommendations for Demonstrating Equivalency of Ready to Assay Cells in Neutralizing Antibody (NAb) Methods Post-Validation Download	Immunogenicity analysis: Challenges and Solutions for PEGylated Biopharmaceuticals Download

A Quick and Efficient Approach to Immunogenicity Assay Development and Optimization using Design of Experiments Download	Novel Approach to Immunogenicity Testing for Therapeutics with High Prevalence of Pre-Existing Antibodies Download	Development and Qualification of PK and ADA Methods for Biosimilar Trastuzumab Download	GLP Validation of a Gyrolab® Assay for the Determination of Interleukin 8 (IL-8) Levels in Cynomolgus Monkey Serum Download

SERVICES & SOLUTIONS RESOURCES
	Immunogenicity >>	Pharmacokinetics (PK) Toxicokenetics (TK) >>
	Biomarkers >>	Biosimilars >>

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