Bio-Analytic Newsletter No. 4/2011
In this Issue:
- Biomarker study plan implementation for pre-clinical and clinical studies
- Pharmacokinetics of natural mistletoe lectins after subcutaneous injection
- Paradigm of combined therapy with two monoclonal antibody therapeutics
- Clinical Biomarkers: Novel tool for pharmacodynamic applications
- 21 CFR Part 11 compliant Imperacer® Workstation
- Immuno-PCR Assay Development Kits: Start an ultra-sensitive assay from scratch
- Use low abundant biomarker for study group profiling
- Clinical Biomarkers: How to optimize biomarker assays for clinical studies
Publications
Biomarker study plan implementation for pre-clinical and clinical studies
Huber and co-worker present an open lable, phase I, monocenter clinical trial describing the pharmacokinetics of a natural drug (mistletoe extract, abnovaVISCUM®). In 15 healthy male volunteers aged 18-42 years, this drug with marketing authorization containing about 20µg/ml natural mistletoe lectin (nML) was detected utilizing a modified sandwich immuno-polymerase-chain-reaction (iPCR) technique after subcutaneous injection. Natural ML was detectable in serum after a single subcutaneous injection and detectability was possible up to 2 weeks after single injection.
Pharmacokinetics of natural mistletoe lectins after subcutaneous injection
Summary: Therapeutic macromolecules can induce immune response, leading to neutralization of the therapeutic effect or even autoimmune reactions and serious health problems. In this Imperacer® bridging assay format, an initial drug tolerace ratio was found at 2000-fold excess of the interfering drug compound. This novel bridging Imperacer® assay revealed a more than 1000-fold increased sensitivity in comparison to an ELISA carried out under identical conditions.
Paradigm of combined therapy with two monoclonal antibody therapeutics
In recent years the amount of therapeutic antibodies as drug has strengthened and become a common strategy for the treatment of various diseases. This article provides insight into a study where 2 monoclonal antibody drugs are applied in a combination biologic therapy. The authors critically address the challenges in development of a corresponding pharmacokinetic assay as well as the immunogenicity rates when the therapeutic antibodies are either applied as mono-therapy or as combination therapy.
Application note: Clinical Biomarkers; Novel Tool for Pharmacodynamic Applications
Biomarkers are currently changing the way we diagnose and treat diseases. Today pharmacodynamic (PD) biomarkers are widely used in the industry elaborating optimal dosing of new drugs and predictive biomarkers have an enormous potential for companion diagnostics. This application note presents a variety of pre-clinical and clinical PD-assays using Imperacer. Some cytokine assay have LLOQs lower than 100fg/ml and therefore allow entirely new biomarker and companion diagnostic strategies.
Products & Services
21 CFR Part 11 compliant Imperacer® Workstation
Chimera Biotec has now launched a 21 CFR Part 11 compliant version of the Imperacer® Workstation. This workstation is designed for cost-effective Imperacer® bioanalysis in GLP-bioanalytical labs.
The core component of the workstation is a real-time PCR unit designed for robust and ultra-sensitive immunoassay read-out.
The Imperacer® Workstation is complemented by Imperacer® assay development kits enabling the quantification of sub-picogram/ml analytical sensitivities combined with 4-Log+ linear dynamic range. The package is designed to perfectly conduct Imperacer® assays in the daily routine and summerizes Chimera Biotec´s 10 year experience in Imperacer® assay development and routine bioanalysis.
Imperacer® assay development kit: Start an ultra-sensitive immuno-PCR assay from scratch
Chimera Biotec offers an Imperacer assay development kit for the acedamic of industrial researcher, to develop an ultra-sensitive iPCR-assay from scratch. The basic reagent and consumable kit contains all necessary components for the establishment of a high sensitive application based on your target-specific antibodies.
The anti-biotin Imperacer® Conjugate "CHI-Biotin" is used as secondary conjugate against a biotinylated antigen-specific primary antibody. Signal read-out is performed by an Imperacer® Reader, which is part of the Imperacer® Workstation.
Prognostic and Predictive Biomarkers; Use low abundant biomarkers for study group profiling
Screening tests to assess whether prospective subjects are appropriate candidates for inclusion in studies have proven to have a significant impact on study outcomes. Moreover regulators in Europe and the US encourage development and qualification of biomarkers to improve all stages of the drug development process. But, what if biomarker candidates are abundant in very low concentrations only? Here we present the use of low abundant biomarkers to specifically screen for drug responders.
New Webinar: Clinical Biomarkers; How to optimize biomarker assays for clinical studies?
This new webinar gives a general introduction to general biomarker applications in clinical studies and an overview on various ligand binding immunoassay technologies and platforms currently used to support biomarker studies. The webinar specifically focuses on the quantification of biomarkers, drugs and proteins at sub-picogram/ml concentrations.
Content:
This 30minutes one-to-one webinar can be ordered free of charge. Order information or schedule your personal webinar directly at the speaker: punnamoottil@chimera-biotec.com |
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 Speaker: B. Punnamoottil, Ph.D., molecular neurobiologist and expert in ultra sensitive ligand binding platforms. |