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While a true dose-ranging study is a clinical trial, Absorption Systems offers in vivo dose ranging studies where titerable doses of a test article or compound are tested against each other to establish which dose is safely tolerated.  A typical study format would include a placebo group of animals, along with several groups that receive higher and higher doses of the test article.

A routine format would include 4-6 test groups that provides a range from low to highest concentrations of the test article along with a group that receives the buffer that the test articles have been re-constituted in. The highest dose tolerated is defined as the maximum tolerable dose (MTD), which then is used to
determine further studies.

Other endpoints that can be generated from this type of testing can be chemistries, hematology panels, blood gases as well as a variety of biomarker measurements and necropsy and histology testing.  Absorption Systems has AAALAC and USDA accredited facilities.

Absorption Systems provides a complete immunoassay validation package that is extensive and in compliance with FDA review. All work is performed under good laboratory procedure conditions (21 CFR Parts 58) and with CFR 320.29 and follows the basic parameters set forth in the “Guidance for Industry: Bioanalytical Methods Validation for Human Studies:
FDA CDER: May 2001”.

Whether the system is a simple screening assay or a quantitative assay used in stability testing, performance characteristics can be defined and assay parameters implemented for day-to-day operations.

Validations can be applied to bioassays, RIA’s, EIA’s, and any other similar type of detection system. A typical validation package would include the following parameters:

• Performance Characteristics – Parameters such as reproducibility, operator-to-operator variation, sample parallelism, sensitivity, specificity, beginning to end variation, assay ruggedness, spike and recovery, freeze-thaw effects and cutoff analysis can be performed to evaluate the performance of the particular assay.
• Assay Acceptability Criteria – Acceptability parameters are established from the validation, which then are used for the determination of assay acceptability. Control charts are utilized to track assay performance and trends that may occur over time. By using this method, overall performance can be monitored assay-to-assay, operator-to-operator, and day-to-day.
• Supporting Documentation – Depending upon the client’s requirements, Standard Operating Procedures (SOP’s), worksheets, and reagent logs are generated and incorporated into the TGA BioServices QA documentation system, resulting in full traceability of all analysis.
• Database Formation and Handling – Specific macros are tailored to each project to ensure that all raw data is electronically transferred during database generation and statistical analysis, thereby eliminating manual input errors.

Absorption Systems offers our clients a complete package of development, optimization and quantification systems utilized in pre-clinical through Phase IV studies, all. in compliance with GLP and cGMP requirements when requested by the client. There is an additional charge for GLP and cGMP methods as compared to RD projects.

We have a strong track record of expertise in the development of complex and infrequently used methods to assist our clients in their research. We offer weekly progress reports and/or teleconferences to ensure the client is up to date on all aspects of their projects.

Capabilities include:

• Measurement of small molecules, peptides and large proteins for RD or product release (cGMP)
• Immunoassays for the monitoring of antibody or protein levels throughout a clinical study in complete compliance with GLP guidelines
• Development of an Immunoassay-based screening protocol against your lead compound
• Assay design and detection systems for antibodies with unique specifications; Quantitative detection systems for antibodies with unique specifications
• Quantitative detection systems for the determination of contaminants in highly purified products
• Immunoassays utilized for the detection of cytokines or cell surface markers
• Use of commercial kits in compliance with cGMP or GLP guidelines
• Monoclonal antibody screening (Western blot or ELISA)

Immunoassay formats include:

• Bridging Assay
• Competitive Technique
• Direct Binding Assay Study
• HACA
• HAMA
• Immunogenicity Assays
• Immunoglobulin Screening
• Isotyping
• Client Specific Assay Formats

Capabilities Include:

• Immunoassay Development
• Immunoassay Validation
• Multiplex Assay

Consulting
As part of our service offerings, immunoassay consulting services in the areas of assay methodology, monoclonal antibody development, purification and other immunochemistry techniques, as well as product development aspects of project management.

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
data.

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:

• ELISA
  • 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
  • Types:
    • Direct
    • Indirect
    • Sandwich
    • Competitive
• 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