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.

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

Benefit from our long and relevant experience to create the most efficient study design, and quickly fill the panel with the special population to meet your objectives. We design, conduct, analyze, and report on pharmacokinetic studies in special populations, either as stand-alone studies or cohorts within larger, healthy normal volunteer studies.

We know it is often vital, depending on the indication, for safety and efficacy to observe the pharmacokinetics in different BMIs, genders, or ages. We have the team in place to overcome the challenge of recruiting healthy participants without conflicting concomitant medications, or populations with higher BMIs, or increasing age.

The recruiting teams across our clinics have robust databases to work from, with over 365,000 participants, and are also experts at participant outreach to continually add to our database. We deliver the patient access and relevant expertise you need.