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.
- 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
- 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