Protea and Agilent collaboration looks to address drug discovery and QA/QC
The West Virginia-based bioanalytical solutions firm will use its metabolic profiling platform with Agilent’s instrumentation to address biopharma workflow challenges for drugmakers under a Memorandum of Understanding (MOU) announced last week.
“We would be applying our technology as a direct analysis tool to characterize a ‘snapshot’ metabolome of an expression system as protein therapeutics are being produced in as close to real time as possible,” Protea’s COO Greg Kilby told this publication.
“The nature of the technology is such that - for this example - no sample prep is required and liquid samples can be analysed in a few seconds.”
Metabolites are produced by all the body’s cells and are essential to all bodily functions. Metabolomics can help identify changes that take place in the metabolic profiles of cells due to disease processes and drug interactions, as well as improve cellular processes that support high production and quality of recombinant protein.
According to Kilby, Agilent has an annotated vendor library of 9000+ metabolites as well as a set of informatics tools for mass spectrometry based workflows.
“We are working with Agilent to apply these tools to this area - once a standardized workflow of sample prep, data collection, and informatics processing is tested and validated, we can apply and scale appropriately.”
Financial details of the deal were not disclosed.
Industry challenges
“There are challenges in all stages of protein/peptide therapeutic drug discovery,” Kilby said, but the collaboration will primarily focus on manufacturing and early development.
“For QA/QC forced degradation studies, typically the industry uses UV detection which is somewhat sensitive and quantitative but does not give insight into the structure of the peptides, or if there are post translational modifications [PTMs] as you will not necessarily know which amino acid is modified if there are multiple sites of modification on the peptide sequence,” he said.
“Mass Spectrometry can provide all this information and more, and is becoming more standardized in industry settings.”
Protea’s offerings also include protein characterization workflows for routine LCMS (liquid chromatography–mass spectrometry) analysis of protein therapeutics - with an emphasis on monoclonal antibodies - from Intact analysis, through sub unit domains, and to peptide maps and post translational modifications.
