Large-Molecule Drug Bioanalysis Service

Creative Biolabs offers a cutting-edge large-molecule drug bioanalysis service that caters to the analytical needs of a wide array of biological products. Our expertise in pharmacokinetics, pharmacodynamics, immunogenicity, toxicokinetics, and biomarkers ensures high-quality services to meet the diverse needs of our customers in the development of therapeutic biological products.

The Importance of Large-Molecule Drug Bioanalysis

The realm of large-molecule drug bioanalysis is critical in modern drug development, where the focus has shifted towards biologics such as proteins, antibodies, ADCs, and more. Understanding the intricate pharmacokinetics, pharmacodynamics, and immunogenicity of these large molecules is paramount in ensuring their safety and efficacy.

Our Large-Molecule Drug Bioanalysis Services

At Creative Biolabs, we offer a wide range of bioanalytical services tailored to meet the diverse needs of our clients throughout the drug development lifecycle. From discovery through preclinical to clinical development phases, our bioanalytical experts leverage state-of-the-art analytical platforms to deliver high-quality data in line with various regulatory standards.

Our Capabilities

Development of novel assays using analytical technologies like HPLC, LC/MS, LBA, and PCR platforms.

Assay development for the analysis of ADA, NAb, and biomarkers of interest.

Conducting GLP-compliant studies including PK, immunogenicity, and biomarker analysis.

Assay optimization for therapeutic biologics in the preclinical development phase.

Standardized global bioanalytical technology platforms for LBA, Serological, and Cell-based assays.

Assay development and optimization for various bioanalytical needs in clinical studies.

Our Platform

Creative Biolabs leverages state-of-the-art analytical platforms to deliver precise and reliable bioanalytical services for large-molecule drug analysis. Our instrumentation platforms include LC-MS/MS, ELISA Assay (Colorimetric, Fluorescence, Chemiluminescence), MSD, PCR, qPCR, Flow Cytometry, ELLA, and ELISpot. These cutting-edge technologies enable us to conduct esoteric and complex assay development, labile compound analysis, tissue sample analysis, antibody-drug conjugate (ADC) projects, and the determination of drug/antibody ratios for ADC projects.

Why Choose us

Creative Biolabs stands as a reliable partner for large-molecule drug bioanalysis services, offering expertise, cutting-edge technologies, and a commitment to regulatory compliance to support the development of innovative biologics in the pharmaceutical industry. If you would like to know more about our services, please feel free to contact us.

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