Advanced Protein Engineering Enhances Biopharmaceutical Manufacturing and Analytics
Article featured in BioProcess International.
Next generation drug products bring new challenges for analytics and biomanufacture. Tools available for well-established processes are not optimal for next-generation drug products including non-antibody protein drugs, biosimilars and antibody drug conjugates (ADCs). In the article “Advanced Protein Engineering Enhances Biopharmaceutical Manufacturing and Analytics” featured in Bioprocess International’s November 2016 issue, we describe how protein engineering can help develop these urgently needed tools.
One major challenge for biomanufacturers is that commonly used tools are limited in their application through processes affecting development and scale up. By using the Orla protein engineering platform OrlaSURF, a molecule can be modified in a way to find use across process steps and across analytical assay formats. Orla fuses relevant active sequences into its proprietary surface binding unit (SBU). These molecules can then be quickly immobilised via a simple apply and wash method onto substrata such as gold, plastic or glass.
Peptide antigen presentation is one of the areas where good orientation and functionality are difficult to achieve through chemical coupling or adsorption. The improved orientation through the OrlaSURF approach increases exposure of the antigen and thereby sensitivity, reliability and reproducibility of an assay. When we engineered the p24 protein of HIV into our surface binding unit and immobilised it on an ELISA plate, there were clear advantages over standard methods. While adsorbed native p24 was only recognised by some antibodies, Orla’s p24 fusion molecule gave improved sensitivity.
The OrlaSURF platform also allows presentation of single chain antibodies in a highly defined way on surfaces. Experiments comparing a range of linker lengths between the Orla SBU and scFv have shown that a longer linker and greater distance of the scFv from the substratum enhances binding due to improved exposure of the scFv biding domain.
Other application areas for OrlaSURF include the development of high-specificity affinity purification ligands for bioseparations, and high-throughput analytical tools. The full article “Advanced Protein Engineering Enhances Biopharmaceutical Manufacturing and Analytics” can be found in Bioprocess International November issue 2016 under http://www.bioprocessintl.com/2016/advanced-protein-engineering-enhances-biopharmaceutical-manufacturing-analytics/