LC-MS/MS-based Quantitative Bioanalysis Service

Creative Biolabs has firmly established itself as a leading service provider in the bioanalytical field with over 20 years of industry experience. We specialize in LC-MS/MS-based quantitative bioanalysis for small molecules, peptides, oligonucleotides, and protein drugs. Our comprehensive suite of state-of-the-art mass spectrometry platforms, coupled with our expertise in method development and validation, ensures the delivery of precise, accurate, and reliable bioanalytical data.

Fig.1 Schematic of immunocapture-LC-MS/MS assays.¹

Characteristics of LC-MS/MS-based Quantitative Bioanalysis

• High Specificity and Sensitivity

LC-MS/MS technology combines the high separation capacity of liquid chromatography (LC) with the high sensitivity and selectivity of mass spectrometry (MS). This integration facilitates the quantitative analysis of nucleic acids, peptides, and proteins in biological samples, providing unparalleled specificity and sensitivity. At Creative Biolabs, we employ signature peptides for protein quantification, offering significant benefits over traditional ligand-binding assays (LBAs).

• Detailed Structural Information

The technology allows the identification and quantification of target analytes with detailed structural information. Unlike LBAs, LC-MS/MS does not require specific antibodies, thus avoiding issues related to cross-reactivity and variability in antibody quality. This capability is crucial for analyzing complex biological samples, where metabolites, degradation products, and post-translational modifications need to be distinguished and quantified accurately.

• Rapid Method Development

Our LC-MS/MS platforms enable rapid method development cycles. The absence of the need for special reagents and probes reduces costs and accelerates the timeline, making it particularly advantageous for early-stage drug development and screening.

• Compliance with Regulatory Standards

Creative Biolabs performs bioanalytical method validation in compliance with international regulatory standards, such as ICH M10. Our stringent validation protocols ensure that our methods meet the necessary criteria for accuracy, precision, specificity, and robustness, which are critical for supporting preclinical and clinical studies.

Applications of LC-MS/MS-based Quantitative Bioanalysis Service

• Pharmacokinetic (PK) and Pharmacodynamic (PD) Studies

Quantitative analysis of protein drugs, oligonucleotides, and small molecules is integral to PK and PD studies. The data obtained from LC-MS/MS analysis provides valuable insights into the drug's absorption, distribution, metabolism, and excretion (ADME) properties. For instance, our high-resolution mass spectrometers can quantify monoclonal antibodies, antibody-drug conjugates (ADCs), and therapeutic peptides, thereby supporting their pharmacokinetic profiling.

• Biotransformation and Metabolite Identification

LC-MS/MS is employed extensively in identifying and quantifying metabolites during drug development. The technology's ability to provide detailed structural information on metabolites helps to elucidate metabolic pathways and potential biotransformations. This information can guide modifications to improve drug stability and efficacy.

• Bioequivalence and Bioavailability Studies

Our LC-MS/MS-based services are pivotal in conducting bioavailability and bioequivalence studies. The precision and accuracy of our quantitative assays ensure reliable data for comparing the pharmacokinetics of test formulations against reference standards.

• Biomarker Discovery and Validation

Creative Biolabs leverages LC-MS/MS for the discovery and quantification of biomarkers. This application is particularly relevant in personalized medicine, where specific biomarkers can guide treatment decisions and monitor therapeutic responses.

Related Services

Scientific Backing

The use of LC-MS/MS for quantitative bioanalysis is well-documented in the scientific literature. Studies have demonstrated its superior specificity and sensitivity compared to traditional LBAs. For example, research on the quantification of protein drugs using multiple signature peptides has highlighted the technique's ability to provide accurate and comprehensive data on protein concentration, structure, and biotransformation.

Fig.2 Signature peptides bioanalysis by LC-MS/MS.¹

Frequently Asked Questions and Answers

Q1: How does LC-MS/MS compare to traditional LBAs?

A1: LC-MS/MS offers higher specificity and sensitivity, does not require specific antibodies, and can provide detailed structural information on analytes, metabolites, and degradation products. This makes it a superior choice for comprehensive bioanalysis.

Q2: How does Creative Biolabs ensure the reliability of their LC-MS/MS methods?

A2: We follow stringent validation protocols in compliance with international regulatory standards. Our methods undergo rigorous testing for accuracy, precision, specificity, and robustness to ensure reliable and reproducible data.

Q3: What is the typical timeline for method development using LC-MS/MS?

A3: The timeline for method development using LC-MS/MS is generally shorter than traditional LBAs due to the absence of a need for specific antibodies and the efficiency of the MS technology. At Creative Biolabs, we strive to deliver rapid and efficient method development to support timely drug development processes.

Creative Biolabs' LC-MS/MS-based quantitative bioanalysis services offer a powerful and versatile platform for the precise quantification of small molecules, peptides, oligonucleotides, and protein drugs. Our expertise in method development, validation, and comprehensive analytical support ensures that our clients receive high-quality data critical for their research and development efforts.

Reference

• Chen, Lin-Zhi, et al. "A Comprehensive Immunocapture-LC-MS/MS Bioanalytical Approach in Support of a Biotherapeutic Ocular PK Study." Pharmaceuticals 17.2 (2024): 193.

For Research Use Only | Not For Clinical Use