We are a team of scientific professionals dedicated to ensuring client success in all aspects of drug development. We focus on providing expert guidance on regulated bioanalysis, with emphasis on phase-appropriate support, based on the needs unique to your program.

We will work with you, as your partner in navigating the scientific and regulatory requirements to ensure successful submissions, including IND, BLA, NDA, and MAA.

Having collectively worked in the regulated drug development space for over 100 years, we can also provide general support in project management and early stage drug development, including biomarker identification and discovery.

We provide bioanalytical support no matter where your program is in the drug development cycle. Whether you need guidance on pharmacokinetic, pharmacodynamic, biological activity, or immunogenicity assay development, we have experts on hand to help. We offer extensive hands-on expertise in ligand-binding assay, cell-based assay, protein purification, and LC-MS platforms, and can help bridge the gap with your GLP-compliant laboratory outsourcing efforts.

Across the range of small to large molecule bioanalysis, including antibody drug conjugates and hybrid molecules, we will work with you to propose a scientifically sound plan of action that will satisfy regulatory requirements and meet your timelines.

As with all peptide and protein therapeutics, appropriate assessment of immunogenicity is a key component to program success. Effective prediction and management of risks associated with antibody-mediated responses are best accomplished through a fully integrated risk assessment, which ideally includes input across multiple organizational disciplines beyond the bioanalytical component, including analytical chemistry, CMC, regulatory, preclinical, and clinical pharmacology and operations.

Lexartys can work within highly matrixed environments to develop immunogenicity risk assessments to identify the major risks and proper resourcing required to ensure program success.