Our Expertise
Smithers provides expert bioanalytical support for preclinical and clinical studies to advance large molecule and biosimilar programs with speed and focus on high quality data delivery. At Smithers, we understand the complexities and challenges involved in developing the PK/TK, immunogenicity, and biomarker assays for these innovative therapeutics. Our state-of-the-art laboratories are equipped with well-established methods to handle complex biological matrices, ensuring delivery of high-quality data for large molecules and biosimilars.Generic PK Assays: What We Offer
Large molecule PK/TK assays are developed for each drug candidate, requiring extensive planning, method development, and validation before the actual study sample analysis can commence. This process can be time-consuming and resource intensive. In contrast, generic PK assay, with its standardized protocol, allows for more rapid initiation of studies, as much of the preparatory work has been predefined. This can lead to quicker generation of PK concentration data, enabling faster progression through the development pipeline. Our generic PK assay with electrochemiluminescence (ECL) detection supports preclinical bioanalysis to provide customers with reliable data ensuring the development process is both efficient and effective.Why Choose Us?
Support: We provide comprehensive services for large molecule biotherapeutics from early-stage development through to post-marketing surveillance.Short Turn-around Time: Standardized protocols result in rapid PK/TK concentration data on bespoke drug molecules.
Customization: We understand that each project is unique. Our services are tailored to meet your specific needs, ensuring delivery of high-quality data and reports so that key program milestones are met.
- Immunogenicity Assays
- Bioassays
- Biomarkers Test Development
- Generic PK/TK Assay to Support Development of Large Molecules and Biosimilars
- Immuno-Oncology Assays
- Monoclonal/Polyclonal Antibody Assays
- CAR-T and TCR Assays For Cellular Therapeutic Support
- Bi-specific antibodies
- Biobetters and Biosimilars
- Bioanalytical Testing Instrumentation
- Lab Automation Equipment