Ultra Sensitive Ligand-Binding Assay Capabilities

Bioanalytical assay development for sample testing services beyond the limitations of classical immunoassays.

There is no need to invest in costly laboratory equipment and acquiring internal expertise regarding ultra sensitive platforms. Continue working on your preferred in-house platform and only outsource case studies where improved sensitivities or related performance criteria is a must. Chimera Biotec is equipped and accustomed to developing ultra sensitive assays from your specifications to fulfill your requirements. As pioneers for ultra sensitive immunoassays and with the longest track record in the CRO industry for ultra sensitive bioanalytics, we specialize in case studies where standard ELISA quantification is just not powerful enough.

Excellence in immunoassay development, validation and bioanalysis is our core motivation on all our platforms.

Especially in the ultra sensitive realm, construction, validation and reproducible production of standards (STD) and corresponding quality control samples (QCs) for accurate quantification is key to fulfilling study needs and regulatory requirements. Biomarkers and biotherapeutic drugs, however, have the potential to interact with the STD-curve matrix in which the analyte is spiked. To avoid dilution effects when spiking the analyte from stock storage buffer into the STD-curve matrix and to avoid serial dilution effects, Chimera works with dispensertechnology down to the femto-liter (fl) volume range. This allows direct spiking of a particular STD or QC concentration into STD-curve matrix without the introduction of serial dilution effects.

How biological specimens are handled is also of great importance - particularly in rare matrix or microsampling study support – wherever limitations on sample volume availability apply. Here at Chimera Biotec we take your sample very seriously. Since even state of the art laboratory equipment can only be as good as the person operating it, our experienced laboratory staff receive ongoing training. They also individually calibrate their own pipettes to ensure accurate pipetting of sample volumes as low as 0.5 µl (500 nl). Experienced and properly trained personnel, together with constant quality monitoring and improvement is vital for ultra sensitive bioanalytical GLP/GCP services.

High sensitivity ELISA (HS ELISA): Our expertise in detection conjugate synthesis and state of the art signal amplification chemistry allows us to optimize ELISA performance. Starting from commercially available kits and reagents, we provide cost effective biomarker quantification to fulfill your requirements within ELISA technical limitations. Custom PK assay development based on your drug specific reagents or uncommon biomarkers is available up to GLP/GCP conform validation and bioanalysis.

Simoa (Quanterix; HD-1 Analyzer): The single molecule array (Simoa) technology from Quanterix combines single molecule analysis with a digital ELISA readout. Analytes are captured in semi-homogenous solution by antibody coated magnetic beads. Beads are trapped in femtoliter sized microcavities and a digital signal (on/off) provides enhanced sensitivity over conventional ELISA. An official Quanterix partner organization, Chimera Biotec has the unparalleled expertise in ultra sensitive analytics to make the most out of Simoa technology. Utilizing sample cooling within the Simoa HD-1 analyzer instrument, Chimera takes the stability of your valuable sample material and fundamentals of ultra sensitive immunoassays very seriously.

MSD S-Plex (MSD): S-PLEX is MSD’s ultra-sensitive assay platform. It can dramatically improve the sensitivity of immunoassays, reducing the lower limit of detection (LLOD) by 10- to 1000-fold over other assay methods. Thes low detection limits enable the measurement of analytes at lower concentrations, reduce sample volume required, and reduce the amount of critical reagents used. The S-PLEX assay format builds on MSD consumables and instruments and leverages MSD’s assay development expertise by using a procedure that is similar to other MSD assay methods.

Imperacer (Chimera Biotec; Immuno-PCR; IPCR): Our proprietary, immunoassay platform Imperacer combines the preeminent specificity of antibody-antigen binding with the extremely powerful signal amplification of DNA analytics, using our patented antibody-DNA conjugates. A double-stranded DNA-tag allows for exponential signal amplification of immunoassay binding events by PCR. This exponential amplification results in ultra sensitive assays with very broad dynamic ranges and - in consequence - to very dilution tolerant assays. Imperacer allows modification of the most sensitive assay procedure toward an assay with the minimal sample volume requirement at the needed level of sensitivity by customized AnySource® sample dilution. Sensitivity can be employed for immunoassay quantification from microliter (µl) volumes of neat sample, still maintaining the needed sensitivity requirement of the study in trials involving microsampling or rare matrix samples.