Why Is It Crucial to Run Bioanalyses of Macromolecular Drugs in Preclinical Studies?

Bioanalysis of anti-obesity biomacromolecules in preclinical studies is essential not only for understanding Pharmacokinetic (PK) and Pharmacodynamic (PD) profiles but also for developing personalized treatment strategies and predicting long-term efficacy and safety. With the growing focus on personalized medicine, comprehensive bioanalytical evaluations detect and quantify macromolecules and their metabolites, providing key insights into absorption, distribution, metabolism, and excretion (ADME). This detailed understanding helps optimize dosing regimens and minimize potential adverse reactions, ultimately paving the way for more effective and safer therapeutic interventions. At Protheragen, we use advanced analytical techniques to ensure accurate characterization, quantification, and functional evaluation of macromolecules.

Unraveling Complexities, Enhancing Efficacies: Your Trusted Partner in Biological Analysis of Macromolecular Drugs

We provide comprehensive bioanalytical services such as ligand-binding analysis, flow cytometry, cell activity assay, enzyme activity assay, etc., for macromolecular drugs to ensure the efficacy and safety of preclinical drug testing. These macromolecular drugs include but are not limited to proteins, peptides, antibodies, and other biologics.

• Ligand-binding Assay

  Ligand binding experiments are used to analyze the interaction between a candidate drug and its target receptor, providing fundamental insights into the drug's mechanism of action. Enzyme-linked immunosorbent assay (ELISA) is a widely used analytical method that stands out in ligand binding assays for target macromolecule drugs due to its specificity, sensitivity, and ease of use. Surface plasmon resonance (SPR), which measures real-time binding kinetics without the need for labels, is measured by monitoring changes in the refractive index near the sensor surface as binding occurs. Isothermal titration calorimetry (ITC) detects binding by measuring heat changes during the interaction, providing detailed thermodynamic parameters. ELISA is suitable for high-throughput screening, SPR provides kinetic data, and ITC provides comprehensive thermodynamic profiles. Each method provides different levels of detail and sensitivity, allowing researchers to fully understand how a drug interacts with its target, and providing information for dose optimization.

• Flow Cytometry

  Flow cytometry is the analysis of the physical and chemical properties of cells or particles as they flow in a beam of light (usually a laser) as a fluid stream. The technique allows researchers to assess things like cell size, granularity, and protein expression levels, providing a detailed profile of how cells are responding to drug candidates. Flow cytometry is used to identify and quantify specific cell populations, monitor immune responses, and assess cell viability and apoptosis. We use fluorescent dye-conjugated antibodies that bind to specific cell markers to analyze multiple parameters simultaneously at the single-cell level. By collecting data from thousands to millions of cells in a matter of minutes, we provide our clients with a fast, quantitative, and highly detailed overview.

• Cell Activity Assay

  We aim to evaluate the intrinsic activity of macromolecules (such as proteins, antibodies, or other biologics) in the cellular environment, gaining insight into how drugs interact with cells and the processes and pathways they act on in cells. Our methods include cell viability assays to measure metabolic activity, proliferation assays to monitor cell division, and reporter gene assays to indicate the activation of cellular pathways. In addition, flow cytometry and confocal microscopy are also used to assess phenotypic changes and elucidate signaling events at the single-cell level. Through these experiments, we help our clients obtain comprehensive data on the therapeutic effects, potency, and possible cytotoxic effects of macromolecule drugs and screen the most promising drug candidates for in vivo studies and preclinical trials.

• Enzymatic Activity Assay

  Enzyme activity experiments are used to evaluate the potency, specificity, and mode of action of drugs targeting specific enzymes, guide drug design, optimize efficacy, minimize off-target effects, and predict potential toxicity. We use various detection methods to measure enzyme activity such as spectrophotometry (monitoring absorbance or fluorescence changes associated with substrate conversion), radioassays (measuring the incorporation or release of radioisotopes), and electrophoresis techniques (such as zymography). These methods enable clients to quantitatively and qualitatively evaluate the effects of macromolecular drugs on regulating enzyme function and support the progress of drug candidates in the development process.

• In Vivo Efficacy

  In vivo animal efficacy experiments are a key step in preclinical macromolecular drug research to evaluate the therapeutic potential, safety, and PD of candidate drugs in vivo. This study is essential to determine the efficacy of the drug and identify any potential adverse reactions that may occur in complex biological systems. We administer candidate drugs to animal models of obesity and monitor various parameters such as obesity progression, behavioral changes, biochemical markers, and survival rates. Comprehensive data is then collected through techniques such as imaging, blood sampling, histopathological analysis, and biomarker testing to determine the optimal dose, therapeutic index, and potential side effects.

Workflow

Applications

• PK studies: Evaluate the ADME of macromolecular drugs. The data obtained are crucial for optimizing drug efficacy and reducing potential toxicity.
• PD studies: Understand the biochemical and physiological effects, mechanisms of action, therapeutic potential, etc., of drugs. These studies usually involve examining drug-receptor interactions, signal transduction pathways and the resulting cellular or tissue responses.
• Toxicity assessment: Evaluate potential adverse reactions and determine the toxic dose range, target organs affected, and the nature and severity of any toxic effects.
• Immunogenicity testing: Detect immune responses to macromolecular drugs, which may affect their efficacy and safety.

Advantages

• We support preclinical bioanalysis services for various types of drugs, including monoclonal antibodies, polyclonal antibodies, antibody-drug conjugates (ADCs), fusion proteins, peptides, gene therapy, vaccines, chimeric antigen receptor (CAR)-T cells, heparin, coagulation factors, etc.
• We provide a full range of testing services, including ligand binding experiments, flow cytometry experiments, cell activity experiments, enzymatic experiments, in vivo efficacy, etc.
• We provide development and optimization of bioanalysis methods for macromolecular drugs and quickly and efficiently complete methodological confirmation in a short period to support the needs of your project.

Our Services

Publication Data

Frequently Asked Questions

What types of macromolecular drugs do you analyze?

We provide biological analysis services for a wide range of macromolecular drugs including but not limited to monoclonal antibodies, polyclonal antibodies, ADCs, fusion proteins, peptides, gene therapy, vaccines, CAR-T cells, heparin, coagulation factors, nucleic acid drugs.

How do you ensure the accuracy of your analytical results?

1) Select high-quality analytical techniques such as MS and chromatography to obtain accurate and reliable data; 2) Strictly adhere to standardized protocols and good laboratory practices to ensure consistency and reproducibility across batches and experiments; 3) Use internal and external controls and calibration standards to verify the accuracy of each analysis; 4) Strict data review and quality assurance measures further ensure the reliability of the results.

Protheragen uses expertise in PK, PD, toxicity, immunogenicity, etc., to provide clients with comprehensive and accurate bioanalysis services to promote the preclinical development stage of macromolecular drugs. For further consultation or discussion of your specific needs, please feel free to contact us, our expert team will actively respond to your needs and customize personalized solutions.

All of our services and products are intended for preclinical research use only and cannot be used to diagnose, treat or manage patients.

• Bioanalysis of Small Molecule Drugs