Immunological and Molecular Analysis
Laboratory methods for immunological and molecular analysis evaluate biological responses by measuring molecular targets such as DNA, RNA, and gene expression, as well as immune-related markers, including cytokines, antibodies, and proteins.
These methods, immunoassays and molecular assays, are commonly applied in healthcare and research. Immunoassays are widely used in clinical diagnostics, disease monitoring, and drug testing to measure specific proteins or antigens. Molecular assays, on the other hand, are vital for genetic testing, pathogen detection, and gene expression studies.
Biomarker Characterization Services
Biomarker characterization provides insight into biological processes such as immune response, inflammation, tissue repair, disease progression, and treatment effects. iFyber uses complementary immunological and molecular methods to measure known biomarkers and characterize broader biological response profiles.
Immunological methods measure proteins that reflect biological activity, while molecular methods evaluate DNA and RNA targets to identify genetic and gene-expression patterns. Together, these approaches provide a more comprehensive view of biological response and help connect molecular changes to functional outcomes.
iFyber's Capabilities in Biomarker Characterization
iFyber combines immunological and molecular approaches to characterize biological responses across in vitro, ex vivo, and in vivo research models. These capabilities enable researchers to quantify key biomarkers, characterize biological response patterns, and connect molecular changes to mechanisms of action and functional outcomes.
Capabilities Include:
- Cytokine and growth factor profiling
- RNA biomarker profiling
- Targeted biomarker analysis
- Multiplex biomarker analysis
- Custom assay development
- In vitro, ex vivo, and in vivo biomarker analysis
Cytokines and growth factors regulate inflammation, tissue repair, angiogenesis, and remodeling. As a preclinical CRO, iFyber combines advanced analytical methods, custom assay development, and in vitro and in vivo models to quantify key biomarkers, characterize biological responses, and support preclinical product development and translational research.
Profiling these biomarkers can help researchers understand:
- Healing & inflammation: Track healing progression, inflammatory resolution, and fibrosis risk.
- Product & mechanism: Characterize biological responses, validate mechanisms of action, and evaluate therapeutic efficacy.
- Wound microenvironment: Assess how wound care technologies, regenerative medicine products, biomaterials, and drug delivery systems influence the biological environment.
RNA biomarkers reflect gene expression, providing insight into the biological pathways and cellular responses active under specific experimental or clinical conditions. iFyber selects the appropriate RNA-based technology based on the biological question, sample type and quality, number of targets, and desired level of analysis.
Profiling can help characterize:
- Biological processes: Inflammation, immune response, tissue repair and remodeling, disease progression, and response to treatment.
- Targeted analysis: RT-qPCR for specific gene analysis and PCR arrays or NanoString for predefined biomarker panels.
- Broader profiling: Microarrays for broader profiling of known genes and RNA sequencing (RNA-seq) for comprehensive transcriptomic analysis and biomarker discovery.
Custom Immunoassays Services
Our experts will work closely with you to design and optimize sample preparation, biomaterials, and detection methods tailored to your specific research needs, optimizing sensitivity and specificity and minimizing variability. If your business requires a unique assay, we have the expertise to develop custom methods from the ground up, meeting your exact requirements.
iFyber's Capabilities in Custom Immunoassays
Depending on the study objectives, our researchers can use commercially available ELISA kits for established biomarkers or develop and optimize custom assays when a suitable kit is unavailable.
Capabilities Include:
- Sample preparation optimization
- Selection of appropriate antibodies, standards, reagents, and assay materials
- Optimization of assay conditions to support reliable biomarker detection and quantification
An enzyme-linked immunosorbent assay (ELISA) is a plate-based method used to detect and quantify known biomarkers, including proteins, antibodies, antigens, cytokines, chemokines, and growth factors. ELISAs can support a range of applications, from evaluating immune and inflammatory responses to measuring disease-associated biomarkers, assessing antibody production, and monitoring treatment effects. Depending on the study objectives, our researchers can use commercially available ELISA kits for established biomarkers or develop and optimize a custom assay when a suitable kit is unavailable.
Multiplexing is the simultaneous measurement of multiple biomarkers in a single sample. Multiplex immunoassays can analyze panels of cytokines, chemokines, growth factors, and other proteins, providing a more comprehensive view of biological responses than testing each biomarker individually.
Custom Molecular Assay Development and Testing Services
From individual research studies to routine QC testing, iFyber develops and implements DNA- and RNA-based assays tailored to the Sponsor’s samples, targets, and study objectives.
We can use established methods and commercial kits, adapt existing assays to new sample types or applications, or develop custom methods when an appropriate approach is not available. Methods can be developed for diverse sample matrices, including cell cultures, tissues and biopsies, swabs, biological fluids, microbial samples, solid materials, and other in vitro and ex vivo samples. When needed, assays can progress through qualification, performance verification, pre-validation, and technology transfer to support routine implementation.
iFyber's Capabilities in PCR-based Assay Development
When an off-the-shelf assay does not fit the target, sample matrix, or required sensitivity, iFyber can develop or adapt a targeted DNA- or RNA-based method for the specific application. Our scientists consider the complete analytical workflow, from sample preparation and nucleic acid extraction through target and primer/probe selection, amplification chemistry, controls, detection, instrumentation, quantification, and data analysis.
Capabilities Include:
- Detection and quantification of microorganisms
- Microbial contamination testing
- Confirmation of microbial identity
- Detection of specific genes or genetic targets
- Gene expression analysis
- Development of molecular methods for research, QC, or lot-release applications
Amplification-based technologies provide highly sensitive and specific approaches for detecting and quantifying DNA and RNA targets. Depending on the application, iFyber can develop and optimize methods using conventional PCR, qPCR, RT-qPCR, or isothermal amplification approaches such as LAMP.
Detection strategies can incorporate fluorescence, colorimetric, or turbidity-based readouts, with assay conditions optimized for the intended sample matrix and instrumentation. Development can also include assessing analytical performance and establishing an application- or clinically relevant limit of detection.
DNA and RNA Analysis, Quantitation and Sequencing Services
iFyber provides DNA and RNA analysis services for molecular characterization across research, product development, and testing applications. Our workflows range from nucleic acid extraction and quantification to targeted molecular analysis and sequencing, tailored to the sample type, analytical objective, and desired level of characterization.
Targeted approaches can support specific DNA or RNA measurements and microbial identification, while 16S rRNA gene sequencing and other NGS approaches enable broader characterization of microbial communities and microbiome composition. For tissue and biomaterial applications, molecular analysis can also assess residual DNA, DNA degradation and fragment size, and nucleic acid removal following decellularization.
Applications include:
- Microbial detection and identification
- Targeted contamination testing, including viral RNA
- Gene expression and biomarker analysis
- Research and product development
- Internal QC and lot-release testing
- Molecular characterization of tissues and biomaterials
iFyber's Capabilities in DNA and RNA Analysis
Whether the goal is to quantify a specific nucleic acid, assess DNA quality, identify a microorganism, or characterize a microbial community, iFyber builds analytical workflows around the sample and scientific question.
Capabilities Include:
- Sample homogenization
- DNA/RNA extraction and purification
- Nucleic acid quantification
- Purity and integrity assessment
- Amplification and targeted molecular analysis
- DNA/RNA sequencing, including 16S rRNA and NGS approaches
Colorimetric and Fluorometric Assay Services
Colorimetric and fluorometric assays provide versatile approaches for measuring protein concentration, enzyme activity, and other biological endpoints based on changes in color or fluorescence.
Applications include:
- Protein quantification and characterization
- Biomarker measurement
- Enzyme activity assessment
- Cell and tissue response studies
- Inflammation and tissue remodeling studies
- Treatment-response evaluation
- Protein expression analysis
- Characterization of biological materials and research samples
iFyber's Capabilities in Colorimetric and Fluorometric Assays
Our researchers can use established methods or develop and optimize custom assays, including sample preparation, material and reagent selection, assay conditions, standard curves, and detection parameters.
Capabilities Include:
- Total protein quantification using BCA, Bradford, or Lowry assays
- Enzyme activity assays for targets such as ALP, LDH, MPO, proteases, and peroxidases
- Protein characterization techniques such as SDS-PAGE and Western blotting to evaluate protein expression, size, purity, and composition
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