Decades of bioanalytical experience with innovators and biosimilars

A successful biosimilar program requires an in-depth understanding of the unique approaches and regulatory expectations for biosimilar bioanalytical methods. With over 25 years of hands-on experience supporting clients with biosimilar products, Celerion provides top-of-the-line laboratory services including pharmacokinetics, immunogenicity, and pharmacodynamic biomarker assessments.

Celerion biosimilar immunogenicity screening workflow

Rapid solutions for clinical biosimilar sample analysis

In the competitive landscape of biosimilars, meeting short timelines is critical. At Celerion, we have extensive, hand-on experience with preclinical and clinical pharmacokinetic (PK), anti-drug antibody (ADA), and neutralizing antibody (NAb) assays for innovators and biosimilars including:

Monoclonal Antibodies
Fusion Proteins
Cytokines
Hormones

Our ability to quickly implement these assays combined with our inspection-ready reports and data delivery make us the number one choice for bioanalytical support of biosimilar programs. View our biosimilars experience for a list of specific therapeutics and associated assays.

Expertise across all stages of biosimilar testing

From comparative studies designed to establish biosimilarity with marketed reference drugs in our clinics to downstream sample analysis for PK, immunogenicity, and biomarker testing, Celerion is a full-service CRO provider for biosimilar drug development. Read our white paper to learn more about our approach to biosimilar method development for PK and immunogenicity assays and view our additional resources for biosimilar clients here:

Celerion biosimilar assay setup diagram