Accelero develops and validates enzyme-linked immunosorbent assays (ELISA) and hybridization-based assays in 96-well and 384-well plate formats for pharmcokinetic and pharmacodynamic purposes, biomarker research, signal transduction, cell culture, and many other applications:
- Direct quantification of drug substances and drug products for PK / TK characterization
- Inflammation marker quantification (cytokines, interferons, hormones)
- Complement activation as a response to drug treatment
- Bead-based assays, e.g. like AlphaLISA
- Sandwich hybridisation assays for the quantification of drugs based on nucleic acid chemistry
- Ligation-based hybridization assays to quantify full length parent RNA or DNA compounds
- Branched DNA assays as an alternative for RTqPCR mediated RNA quantification, also for RNA transkript vaccines
- Immunogenicity assays, antibody detection assays (early IgM, late IgG)
- Real-time enzyme activity assays
- Triglyceride and phospholipid determination (sphingosine-1-phosphate, ceramide, sphingosylphosphorylcholine, etc)
Accelero´s multimode plate reader is fully IQ/OQ/PQ qualified, and validated in compliance with the respective guidelines for computerized systems.
Test System / Instrumentation: Synergy 2 Multimode Plate Reader (BioTek Instruments), 21 CFR part 11 compliant
All assays intended for submission to a regulatory authority will be fully developed and validated according to (a) the EMA guideline for bioanalytical method validation, or (b) the ICH Q2 R1 guideline on the validation of analytical procedures.
Toxicokinetic Hybridisation Assays
For the direct quantification of aptamer drugs, siRNA, microRNA mimics, antagomirs, or CRISPR-RNA (crRNA) we recommend to apply the enzyme-linked hybridisation assay (ESHA):
- Hybridization assays are always part of Accelero´s everyday routine, and can easily be adopted to your molecule within days (all materials and reagents are already in stock);
- Hybridization assays have been applied for numerous drug development projects, and are accepted by many regulatory authorities;
- Hybridization assays are less expensive e.g. than LC-MS/MS based methods (price per sample lowers by 30-50% !);
- No sample preparation is required, the sample is directly subjected to the assay;
- Suitable for label-free biodistribution studies, e.g. in the course of nanocarrier characterization
In case a more sensitive assay is needed, because e.g. immuno-modulatory oligonucleotides are administered at very low doses or via an exceptional route, Accelero offers a range of qPCR and RTqPCR assays. Please contact the Accelero team to learn more about our qPCR capabilities.
If you are looking for ELISA and hybridization assay development services which have not been listed here, please do not hesitate to get in touch with us for additional information. Accelero is looking forward to help you!
Last update of this site: 01-NOV-2016 by Christian Lange