Large Molecules & Biologics

Biopharmaceutical products represent a class of therapeutics used to treat various serious diseases. Unlike traditional small-molecule drugs, these complex biological products are designed to target specific mechanisms within the body, offering precise and effective treatments for a range of diseases. As they are produced in living organisms using sophisticated biotechnological processes, ensuring their safety, quality and effectiveness is critical.

Eurofins BioPharma Product Testing provides comprehensive analytical solutions tailored to the unique challenges of therapeutic biologics, from early-stage development through commercial release. With a commitment to regulatory compliance and scientific excellence, we support your mission to deliver safe and effective therapies to patients worldwide.

With over 30 years of experience in the biopharmaceutical sector we can support you across a wide range of product types including the following:

• Therapeutic Monoclonal and Bispecific Antibodies 
• Antibody Drug Conjugates (ADC) 
• Proteins and Peptides 
• Cytokines (e.g., interferons)
• mRNAs and DNA
• Oligonucleotides
• Vaccines 
• Cell and Gene Therapies (ATMPs) 
• Therapeutic Enzymes

With many years of experience, a team of highly experienced experts and state-of-the-art facilities and analytical technologies, Eurofins has built a strong reputation for excellence in biopharmaceutical testing. From analytical assays, bioassays to microbiological assessments, we offer the full range of services to support your product development and regulatory compliance needs. 

• Longstanding experience in development, validation and performance of bioassays (1984 - present) and other QC-related analytical methods with global client base 
• Release and stability testing for US, EU, Japan and many ROW countries 
• Deep understanding of regulatory requirements for Biologics 
• Dedicated analyst /scientist training and coaching teams 
• Realization of special requests possible using Full Time Equivalent (FTE) team approach (e.g. shortening TAT to 10 business days for cell-based assays) 
• Dedicated project management and sample management teams 
• One Stop Shop: Bioassay & Protein analytics & Microbiology 
• Network of harmonized bioassay labs in EU, US and Japan 

Whether you’re a pharmaceutical company or biotech firm, we are here to support your testing requirements at every stage. Visit our website to learn more about our services or contact our team to discuss your specific needs.

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