Bioanalysis services supporting drug discovery/development via state of the art facilities
AxisPharm bioanalytical services encompass a wide range of scientific and analytical services focused on the characterization, measurement, and analysis of biological molecules and compounds. These services are crucial in drug discovery and development, clinical research, biomarker analysis, and other areas of life sciences.
AxisPharm is a San Diego based bioanalytical LC/MS/MS service provider with more than 25 years experience in the field. Our bioanalytical chemistry department specializes in developing and validating robust bioanalytical methods for PK/TK sample analysis of small molecules, proteins, peptides, and metabolites using LCMS/MS (HPLC, UPLC, on-line SPE), HPLC/UV, and HPLC/FL. We have experience analyzing API and metabolites in various biological matrices and can provide bioanalytical support throughout all the stages of drug development.
Bio Analytical Services by Service Type
1. Method Development and Validation
Bioanalysis method development and validation are essential steps in ensuring accurate and reliable measurement of analytes in biological matrices. These processes involve optimizing analytical methods and assessing their performance to meet regulatory requirements and scientific standards.The key steps involved in bioanalysis method development and validation are: Method Development, Method Validation, Documentation, Regulatory Compliance.
2. Quantitative Analysis
Bioanalytical quantitative analysis involves the accurate determination of the concentration or amount of a specific analyte in biological samples. It plays a crucial role in various fields such as pharmaceuticals, clinical research, environmental monitoring, and food safety. The key aspects of bioanalytical quantitative analysis are Method Development, Calibration Curve, Quality Control Samples,Validation Parameters,Internal Standards,Data Analysi, Regulatory Compliance.
3. Bioavailability and Pharmacokinetics Studies
Bioanalytical services providers conduct studies to assess the bioavailability and pharmacokinetics of drugs or compounds in biological systems. This involves measuring drug concentration in blood, plasma, tissues, or other matrices at various time points to determine absorption, distribution, metabolism, and elimination profiles.
4. Biomarker Analysis
Biomarkers play a crucial role in disease diagnosis, patient stratification, and monitoring treatment response. Technologies, such as, immunoassays, LC-MS, PCR, and next-generation sequencing (NGS) are widely used for biomarker identification, quantification and validation. Biomarkers can be molecular, cellular, biochemical, or imaging-based, and they play a crucial role in various fields, including medicine, clinical research, drug development, and diagnostics. The key aspects of biomarker analysis are Biomarker Identification, Biomarker Quantification, Validation and Standardization, Clinical Applications, Regulatory Considerations,Biomarker Panels and Signature Analysis,Technological Advances.To read more about Biomarker Analysis.
5. Pharmacodynamics Studies
Pharmacodynamic studies assess the effects of drugs or compounds on biological systems. This involves measuring changes in biomarkers, physiological responses, enzyme activities, receptor binding, or cell signaling pathways and finding the relationship between drug concentration at the site of action and the resulting pharmacological effects on the body. These studies provide insights into how drugs interact with target receptors, enzymes, or cellular pathways, and how those interactions lead to therapeutic or adverse effects. The key aspects of pharmacodynamics studies are Drug-Target Interaction, Dose-Response Relationship, Mechanism of Action, Efficacy and Potency, Time Course of Action, Receptor Occupancy, Biomarker Analysis, Drug-Drug Interactions.
6. Metabolomics and Proteomics
AxisPharm provides comprehensive metabolomics and proteomics analysis, which involves profiling and quantification of metabolites or proteins in biological samples using techniques such as LC-MS, GC-MS, and mass spectrometry-based omics analysis. Metabolomics and proteomics are two powerful disciplines within bioanalysis that focus on the comprehensive analysis of metabolites and proteins, respectively. They provide valuable insights into the biochemical processes, functional pathways, and disease mechanisms in biological systems.Metabolomics and proteomics in bioanalysis inlcudes Sample Preparation, Analytical Techniques, Data Analysis, and Applications.
7. Toxicology Studies
Toxicology studies in bioanalytical research aim to evaluate the safety and potential adverse effects of drugs, chemicals, or compounds. These studies involve analyzing samples to determine the presence and concentration of toxic compounds or their metabolites. Bioanalytical techniques play a crucial role in toxicology studies by providing quantitative measurement and characterization of the toxicant and its metabolites in biological matrices.Toxicology studies in bioanalytical analysis include Exposure Assessment,Pharmacokinetics,Biomarker Analysis,Dose-Response Assessment,Metabolism and Biotransformation,Species Comparison and Extrapolation,Analytical Method Development and Validation,Regulatory Compliance.
8. Bioanalytical Data Analysis
Bioanalytical data analysis is a crucial step in interpreting and extracting meaningful information from the large datasets generated during bioanalytical studies. It helps researchers draw meaningful conclusions and make informed decisions based on their experimental data. Some key aspects of bioanalytical data analysis are Data Preprocessing, Descriptive Statistics, Data Visualization, Hypothesis Testing, Regression Analysis, Multivariate Analysis, Machine Learning, Data Integration, Statistical Software, Interpretation and Reporting.
Bioanalytical Services by Analytes
1. Small Molecule Analysis
Small molecule analysis in bioanalytical research focus on the analysis of small molecules, such as drugs, metabolites, lipids, hormones, and environmental contaminants. It involves the identification, quantification, and characterization of small molecules (typically organic compounds) in biological samples. These small molecules can include endogenous metabolites, drugs, drug metabolites, environmental pollutants, and other biomarkers. Liquid chromatography-mass spectrometry (LC-MS), gas chromatography-mass spectrometry (GC-MS), high-performance liquid chromatography (HPLC), or other spectroscopic methods are widely employed in small molecule analysis. The key aspects of small molecule analysis in bioanalytical research are Sample Preparation, Analytical Techniques, Quantification and Calibration,Validation, Data Analysis, Applications.
2. Protein Analysis
Protein analysis in bioanalytical research involves the identification, quantification, and characterization of proteins in biological samples. Proteins play crucial roles in various biological processes and are involved in numerous diseases and physiological conditions. Protein analysis provides insights into protein expression, post-translational modifications, interactions, and functional activities. AxisPharm’s protein services specialize in protein characterization, quantification, and identification in complex samples. The techniques we utilize here including enzyme-linked immunosorbent assays (ELISA), western blotting, mass spectrometry-based proteomics, protein sequencing, and protein interaction studies. The key aspects of protein analysis in bioanalytical research are Sample Preparation,Protein Separation Techniques,Protein Identification,Quantification Techniques,Post-Translational Modification Analysis,Protein-Protein Interactions,and Protein Structural Analysis.
3. Nucleic Acid Analysis
Nucleic acid and oligonucleotide analysis in bioanalysis involve the characterization, quantification, and manipulation of nucleic acids, such as DNA and RNA, and their synthetic counterparts, oligonucleotides. These analyses play a vital role in various areas of biological and biomedical research, including genomics, transcriptomics, molecular diagnostics, and therapeutic development. The key aspects of nucleic acid and oligonucleotide analysis in bioanalysis are Nucleic Acid Extraction,DNA/RNA Quantification, Polymerase Chain Reaction (PCR),Gel Electrophoresis,Nucleic Acid Sequencing,Oligonucleotide Synthesis,Oligonucleotide Modification Analysis,Nucleic Acid-Protein Interactions,Next-Generation Sequencing Data Analysis.
4. Biomarker Analysis
These services specialize in the identification, quantification, and validation of biomarkers, which are measurable indicators of biological processes, disease states, or responses to therapy. Biomarker analysis may involve a range of techniques, such as immunoassays, LC-MS, PCR, or proteomics-based approaches.
Metabolomics services focus on the comprehensive analysis of small molecule metabolites in biological samples. This involves identifying and quantifying metabolites to gain insights into metabolic pathways, disease mechanisms, and drug metabolism. Techniques utilized include LC-MS, GC-MS, and NMR spectroscopy.
These services are dedicated to the analysis of drug concentrations in biological matrices to determine drug absorption, distribution, metabolism, and elimination profiles. Techniques employed may include LC-MS, immunoassays, or other validated methods for drug quantification.
6. Toxicology Analysis
Toxicology services analyze the presence and concentration of toxic compounds, environmental contaminants, or their metabolites in various matrices. Techniques utilized may include LC-MS, GC-MS, or other validated methods for identification and quantification of toxic substances.
Bioanalytical Services by the Instruments and Technologies Used
1. Mass Spectrometry (MS) Services
AxisPharm provides services that focus on the analysis of biomolecules using mass spectrometry techniques, such as liquid chromatography-mass spectrometry (LC-MS) or gas chromatography-mass spectrometry (GC-MS). Our MS services cover metabolomics, proteomics, small molecule analysis, drug quantification, and structural characterization.
2. Chromatography Services
Chromatography-based services involve the separation and analysis of complex mixtures of biomolecules. Techniques include high-performance liquid chromatography (HPLC), gas chromatography (GC), and ion chromatography (IC). These services are commonly used for separation, purification, and quantification of small molecules, proteins, peptides, and other compounds.
Immunoassay ServicesImmunoassay services utilize techniques based on the specific binding of antibodies to target analytes. This includes enzyme-linked immunosorbent assays (ELISA), western blotting, and immunohistochemistry (IHC). Immunoassays are commonly employed for protein quantification, biomarker analysis, and antibody characterization.
3. Nucleic Acid Analysis Services
These services focus on the analysis of nucleic acids using techniques such as polymerase chain reaction (PCR), DNA sequencing, gene expression analysis, genotyping, and nucleic acid isolation and purification. These services are essential for applications such as genetic testing, mutation analysis, and gene expression profiling.
4. Microscopy and Imaging Services
Microscopy and imaging services involve the use of microscopy techniques for visualization and analysis of biological samples. This includes fluorescence microscopy, confocal microscopy, electron microscopy, and digital imaging. These services are employed for cellular imaging, subcellular localization, histology, and other imaging-based analyses.
5. Other Spectroscopy Services
Spectroscopy-based services utilize techniques that measure the interaction of biomolecules with light, including UV-visible spectroscopy, infrared spectroscopy (IR), nuclear magnetic resonance spectroscopy (NMR), and fluorescence spectroscopy. These services are employed for structural analysis, chemical characterization, and biomolecular interactions.
6. Next-Generation Sequencing (NGS) Services
NGS services involve high-throughput DNA or RNA sequencing using technologies like Illumina, Ion Torrent, or PacBio sequencing platforms. NGS services are essential for genome sequencing, transcriptomics, epigenomics, and metagenomics.
Most Used Bioanalytical Technologies and Methods
1. Liquid Chromatography-Mass Spectrometry(LC-MS)
LC-MS (Liquid Chromatography-Mass Spectrometry) is a widely used technique in bioanalysis for the quantitative measurement of small molecules, peptides, proteins, metabolites, and drugs in biological samples. It is a powerful technique that combines the separation capabilities of liquid chromatography with the detection and identification capabilities of mass spectrometry. Read more about the step-by-step overview of LC-MS bioanalysis.
2. Enzyme-Linked Immunosorbent Assay (ELISA)
ELISA (Enzyme-Linked Immunosorbent Assay) is a widely used technique in bioanalysis for the detection and quantification of specific proteins, peptides, antibodies, hormones, cytokines, and other analytes in biological samples. It utilizes the specific binding of antibodies to target analytes. ELISA is a versatile and sensitive technique used in various fields, including clinical diagnostics, pharmaceutical research, immunology, and molecular biology. It enables the detection and quantification of specific analytes in biological samples, aiding in disease diagnosis, biomarker discovery, therapeutic monitoring, and research investigations.
3. Polymerase Chain Reaction (PCR)
PCR is a widely used molecular biology technique that allows for the amplification of specific DNA or RNA sequences. It is utilized for applications such as gene expression analysis, genotyping, mutation detection, and infectious disease diagnosis.
4. Next-Generation Sequencing (NGS)
NGS is a high-throughput sequencing technology that enables the analysis of large-scale genomic, transcriptomic, epigenomic, and metagenomic data. It has revolutionized genomics research, enabling comprehensive analysis of genetic variations, gene expression profiles, and microbial communities.
5. High-Performance Liquid Chromatography (HPLC)
HPLC is a versatile technique used for the separation, quantification, and purification of various compounds, including small molecules, drugs, peptides, and proteins. It is employed in a wide range of applications, including pharmaceutical analysis, metabolomics, and environmental monitoring.
6. Flow Cytometry
Flow cytometry is a technique that analyzes individual cells or particles as they pass through a laser-based system. It allows for the characterization, quantification, and sorting of cells based on their size, morphology, and specific markers. Flow cytometry is commonly used in immunology, cell biology, and clinical diagnostics.
Bioanalytical Services in Vitro ADME and In Vivo DMPK
AxisPharm bioanalytical laboratory is well equipped with all the necessary tools and instruments to perform the following bioanalytical services in vitro ADME tests.
- Solubility Test
- Microsomal Stability Assay (Mouse, Rat, Dog and Monkey)
- Hepatocytes Stability Assay
- CYP450 inhibition (1A2, 2C9, 2C19, 2D6 and 3A4)
- CaCO2 Permeability Assay
- MDCK-MDR1 Permeability Assay
- Plasma Protein Binding
- Blood-to-Plasma Ratio (Red Blood Cell Partitioning)
In the area of in Vivo DMPK, AxisPharm offers the following bioanalytical services in species such as mouse, rat, dog, monkey, cat, rabbit, guinea pig, and etc.
- Single Dose PK
- Dose Proportionality (Ascending Dose)
- Dose Linearity (Multiple Dose)
- Cassette PK (I.V.)
- Blood-Brain Barrier Permeability Study
- Tissue Distribution
- Mass Balance
- PK Formulation Screening and Optimization
We also provide pre-formulation and formulation stability, degradation monitoring, and so on.
Our bioanalytical laboratory can perform all the sample treatment procedures including protein precipitation, solid phase extraction, and liquid-liquid extraction.
To submit PK samples, we will need the following items included in the package:
- At least 1 mg pure compound
- About 1 ml formulated solution that is the same as used for animal administration (esp. for none PO delivery)
- At least 2 ml blank serum or biological fluid the same type as the samples
- At least 100 µl sample amount for each sample