Biologics / Biosimilars
Our integrated preclinical to early clinical offering covers recombinant proteins, monoclonal antibodies, oligonucleotides, vaccines, and gene 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
- 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
Our deep expertise and capabilities in a broad range of therapeutic areas encompasses preclinical and early clinical studies for both small molecules and biologics. We can manage your entire program, as well as provide support research services and bioanalytical expertise.
Please see Therapeutic Areas for a fuller discussion of our capabilities and expertise.