JavaScript is disabled. Please enable to continue!

Mobile search icon
Eurofins >> BioPharma Services >> Bioanalysis >> Resources

Scientific Resources

Sidebar Image

Datasheets  Case Studies Guidance Documents   Posters   Eurofins BioPharma News   Webinars   White Papers 


 

 

 

 

 

Testing Services for Large Molecule Drug Development

Download Booklet

Immunogenicity, Pharmacokinetics, Biosimilars & Biomarkers

Download Flyer 

Eurofins Pharma Bioanalytical Outsourcing Partner of Choice 

Download Brochure

 

 

 

 

 

 

 

 

 

 

Eurofins BioPharma Services End-to-End Integrated Lab Performance

Download Booklet

   

 


 

Case Studies

 

Successful Cell-Based ADA Collaboration in mRNA Gene Replacement Therapy - Reducing Time and Variability

Download

 

Delivering Flexibility in a Multi-site Global Harmonized Clinical Trial

Download

 

A Clinical Sample Receptor OccupancyAssay Using Flow Cytometry

Download

 

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

Download


 

Guidance Documents

 

 

 
 
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

   

Posters

 

 

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 >>