Our Solutions

Biologics / Biosimilars

Our integrated preclinical to early clinical offering covers recombinant proteins, monoclonal antibodies, oligonucleotides, vaccines, and other therapies. We have extensive experience in study design and PK/PD analysis of novel biologics and biosimilars in preclinical and clinical settings.

Our bioanalytical team analyzes biologics by LC-MS/MS and ligand binding, starting in animal matrices and moving to human. We measure anti-drug antibodies generated and determine if they are neutralizing using competitive binding or functional assays.

Our purpose-built clinics provide the close oversight required for treatment with novel biologics and biosimilars, and offer a high level of safety as well as comfort to participants for efficient recruitment and long-term retention.

We design, conduct, analyze, and report our studies in-house, drawing on our regulatory consultants, our experts in clinical conduct on biologics, and our biostatisticians, data managers, and medical writers with relevant experience in biologics and biosimilars.

Looking to conduct a study? View this list of biosimilars and contact us to discuss further.

Case Studies

  • Assessment of the IonKey/MSTM Technology to Reach Ultra High Level of Sensitivity for Bioanalysis Quantification of Large Molecules in Plasma
  • Application of Complementary HRMS Methodologies for a Thorough Biosimilar Comparability Assessment
  • Application and Advantages of HRMS in the Quantification of Therapeutic Monoclonal Antibodies: “The Rituximab Case Study”
  • PPIP Extraction to Resolve Specificity and Sensitivity Issues: Bioanalysis of a PEGylated Human Protein Analog
  • Quantitative Bioanalysis of Rituximab and Reditux for Biosimilarity Assessment: Comparing Triple Quadrupole and Hybrid Time-of-Flight Platforms

Consult our general Biologics/Biosimilars Fact Sheet

PARTICIPANTS

  • Healthy Normal Volunteers
  • Patient Populations
  • 40% of recent preclinical and clinical studies conducted on large molecules
  • 20 clinical
  • 70 bioanalytical
  • 10 scientific and data services
  • 14 PK comparison of test vs. reference studies
  • 6 immunogenicity studies
  • 8 PD studies