In many biocatalytic or drug discovery projects, the development of bespoke assays is a key aspect of the project.
Our experienced chemistry team can use pre-existing or develop and validate new assays, for example, to support drug discovery and development screening cascades (from standard chemical analysis of properties such as solubility and stability to development of bespoke bioanalytical analyses of samples) or develop assays to support biocatalysis projects (such as directed evolution studies).
Our chemistry team have backgrounds that span many areas of chemistry – from analytical development to protein chemistry, from natural products chemistry to organic synthesis. This enables us to develop and run assays in a variety of formats and readouts, from spectrophotometric or fluorometric to assays requiring HPLC or LCMS.
- Development of analytical methods - to support the development of a process to produce an existing or engineered compound, such as an antibiotic, agrochemical, food ingredient or healthcare product.
- Development of DSP methods - to extract and isolate products from a previously developed USP fermentation method.
- Isolation and supply of material for testing - we have isolated amounts from milligrams to grams in-house on a wide variety of projects. These have been shipped directly to partners or we have helped manage screening cascades by storing materials at Isomerase and sending them directly for biological or chemical testing.
- Isolation of low-level background products - our chemists are highly experienced at isolating compounds from complex mixtures, using techniques such as preparative HPLC. We have supported partners by isolating low-level background contaminants, for example, to support regulatory filings.
- Semisynthetic chemistry on Natural Products - we have supported drug discovery analog campaigns by carrying out semisynthetic chemistry in tandem with the generation of bioengineered analogs.
- Chemical synthesis of small molecules - whilst it is not a core capability, we are able to carry out in-house synthetic chemistry to support projects and have managed external chemistry teams on behalf of partners.
- Assay development - we have supported screening cascades with standard chemical analysis of properties such as solubility and stability and developed assays to support biocatalysis projects and drug development.
Why might assay development be required on a biocatalysis project?
We often develop assays hand in hand with enzyme ID, expression and engineering studies. This enables us to first confirm the desired enzyme activity, then optimise the expression and downstream processing and if required engineer and improve the activity in line with the requirements of the project.
It is critical that the assay is developed to separate, and quantify, the target compound from any related substances.
Assay development is particularly important for directed evolution studies – developing an assay with the throughput and sensitivity to enable the selection of an enzyme with improved properties.
The assays we develop are used to perform final development and validation with CDMO partners for producing target compounds under GMP control.
Contact us for more information about assay development services at Isomerase, directed evolution studies, and protein chemistry services or to request a quote.