Pharmacokinetic (PK) and Toxicokinetic (TK) Bioanalysis
CMIC PK and TK Services in the US
CMIC PK and TK Services in the US
CMIC is your trusted partner for comprehensive Pharmacokinetic (PK) and Toxicokinetic (TK) bioanalysis. Our Chicago-based laboratory specializes in the accurate quantification of therapeutic agents across a broad spectrum of biological matrices, ensuring reliable results that propel your drug development process forward. Our state-of-the-art facility and dedicated team are committed to delivering high-quality, timely services tailored to your specific needs.
Expertise in Small and Large Molecule Bioanalysis
At CMIC’s Chicago Laboratory, we handle a diverse array of therapeutic entities, from small molecule chemical compounds to complex large molecule modalities. Our capabilities extend to the analysis of oligonucleotides, monoclonal antibodies, bispecifics, antibody-drug conjugates (ADCs), and other protein-based drugs. Our direct communication approach ensures seamless collaboration between your scientists and ours, facilitating the generation of reliable study results crucial for regulatory approval.

Advanced Chromatography Techniques
Our chromatography group excels in the quantification of small molecules, oligonucleotides, and peptides, including those encapsulated in lipid nanoparticles (LNPs). Utilizing ultra-high performance liquid chromatography (UHPLC), we achieve the necessary separation power to isolate various analytes. This process is enhanced by our advanced detection techniques, including tandem mass spectrometry (LC-MS), tandem fluorescence (LC-FD), and tandem ultraviolet (LC-UV) analysis. These tools provide unmatched sensitivity, specificity, and throughput, essential for precise bioanalysis.
Specialized Ligand Binding Assays
Our ligand binding assay group has extensive experience with a wide range of biotherapeutics. We understand the urgency of IND-enabling toxicology studies and offer rapid validation and sample analysis to meet tight deadlines. For monoclonal antibodies lacking specific reagents, we recommend generic human IgG assays for efficiency. When soluble targets or anti-idiotypic antibodies are available, we develop specific methods tailored to your therapeutic needs, including antibody selection if required. Our approach ensures accurate results across all dose groups, with a focus on dilution linearity and target interference assessment.
Transition from Preclinical to Clinical Bioanalysis
As your therapeutic progresses to clinical stages, our team in Chicago adapts to meet evolving bioanalytical requirements. We transition assays to human matrices or develop new assays for clinical bioanalysis, emphasizing the increased sensitivity often required at this stage. Method validation is performed in accordance with ICH M10 guidelines, ensuring compliance and reliability. We recognize the importance of rapid sample result availability during ascending dose clinical studies and provide expedited turnaround times for each batch of samples.