Absorption Systems (FDA/EMA registered and inspected) provides GLP, GCLP, and cGMP regulatory-compliant services for RUO, pre-clinical toxicity studies, clinical trials, and batch release testing. We offer dedicated QA/QC personnel to insure compliance to required guidelines and the highest quality of the
Our team has many years of experience in the development and validation of immunoassays for compound screening, ADA, Nab, PK, biomarkers testing using variety of methodologies. We provide the white gloves service covering all aspect of your bioanalytical needs from preparing the sample collection kits and training the clinical sites for proper specimen’s management to creating a FDA-ready Validation and/or Sample Analysis Reports.
Immunological Testing (R&D, cGMP, GLP)
Core Expertise and Technology:
- Validate the commercial kits, assay transfer or develop the test from the scratch (LDT).
- Can perform Assay Qualification, RUO Validation, and GxP Validation
- Any applications related to antigen -antibodies interaction
- Large molecules and protein PK studies
- ADA, TAb, NAb detection
- Quantitative Western Blot
Western blot analysis is an immunological testing method that can detect a protein of interest from a mixture of a great number of proteins. Western blotting generates information about the size of a protein and how that protein is expressed when compared directly to a control sample. Samples for analysis can include cells, tissues, and synthesized recombinant proteins. The success of the western blot method depends upon the quality and specificity of the antibodies used to detect a response against a specific protein of interest.
Absorption Systems can generate a method for a western blot utilized in either R&D applications or in a GLP/cGMP study. There is an additional charge for GLP and cGMP methods as compared to R&D projects. Using the Syngene System, western blots can be quantitated through the GeneSnap Software and particular methods can be validated for use in clinical trials.
- Enzyme Activity Assays
- ELISpot and FluoroSpot
- Assays in 96-well plates allow rapid analysis of large numbers of samples
- Quantification of the number of cytokine (for example IFN-γ or TNF-α) secreting cells.
- The ELISPOT assay can be used to determine effects of drugs or other compounds on cytokine secretion in vitro.
- Monocytes/macrophages/dendritic cells characterization
- Apolipoproteins analysis
- The ELISPOT assay can be used to determine the frequency of antigen-specific cytotoxic T cells (CTL) in fresh unstimulated peripheral blood.
- Luminex Multiplex Technology
- Luminex technology is based on the principles of Flow Cytometry. It uses a single 5.6 micron size microspehere that are dyed with red and infrared dyes in different combinations to create 500 uniquely colored microspheres.
- Luminex bead array assays are widely used for rapid biomarker quantification
- Assessment of serological immunity after successful vaccination
- Assessment of immunogenicity
- Cytokines, chemokines and growth factors
- Cell signaling pathways
- Adverse effect diagnosis, for example, cytokine storm, by comparing a baseline samples to various time points after administration of vaccines
- Ready to use kits from Vendors (Affymetrix, Millipore, Bio-Rad etc) or use in-house developed kits.
- Fluorescent/Luminescent Assays
- PCR, qPCR, and ddPCR
- Transduction/Transfection efficiency
- Retroviral vector-based gene therapy products testing
- Analysis of patient PBMC for RCR-specific DNA sequences
- Determination of efficacy of drugs on target genes
- Analysis of the spread of diseases virus, bacterial, parasites
- Viral Shedding
- Gene Expression
- Mutation Detection
- Genetic Variation