WP5: Protocol for the characterisation of purity for biological macromolecules and cells

Pure materials that can be characterised by non-selective physicochemical methods whilst retaining sufficient commutability for use as higher-order calibrators offer an important route to achieving traceability in an important subset of biological measurements.

The aim of this work package is to develop and assess measurement methods for the characterisation of purity for biological materials intended for use as higher order calibrators in SI traceable biological measurements and, following from this evaluation, to develop internationally agreed guidelines (input into D6.1.11) for characterising such materials and assigning an uncertainty to the corresponding copy number or amount-of-substance values.

The work package comprises four principal activities:

  1. Development of existing individual purity characterisation techniques to bring current practice up to the standards of traceability and uncertainty evaluation required for higher order traceability. This comprises three parallel tasks; one covering nucleic acids, one covering lipoprotein aggregates and one covering cell purification.
  2. Research to develop Next Generation Sequencing (NGS) approaches as a novel purity assessment method for nucleic acids to improve future estimates of purity.
  3. Development of methodology for combining the results from different individual purity assessment methods into a single traceable value with a valid statement of uncertainty.
  4. A workshop to provide input into the requirements for characterisation of pure protein standards.