Coriolis Pharma, of Martinsried, Germany, has become the first pharmaceutical contract research organisation to use Archimedes, a new analytical instrument supplied by UK-based Malvern Instruments, on a regular basis. Coriolis Pharma specialises in formulation development for biopharmaceuticals such as proteins, peptides and vaccines and offers a variety of services to support product development.
Archimedes uses resonant mass measurement (RMM) to detect and accurately count particles from 50nm to 5µm in diameter, and to measure their buoyant mass, dry mass and size. It has applications in the quantitative characterisation of protein aggregates in the size range currently of new regulatory interest, from 0.2µm to 2µm diameter, where aggregates are considered to have a high likelihood of eliciting an unwanted immune response. Archimedes can distinguish between proteinaceous material and contaminants such as silicone oil, which is said to be unique for this size range.
'The teams at Coriolis Pharma have extensive expertise in protein analysis, especially in the field of protein aggregation and degradation, and were early to recognise the benefits of applying resonant mass measurement within our formulation development regimes,' said Andrea Hawe, CSO at Coriolis Pharma. 'Our pioneering testing and adoption of the highly innovative Archimedes now enables us to more easily measure protein aggregates and silicone oil droplets in a critically important size range. This has added a new dimension to our protein characterization capabilities and to the service we provide for our clients.'
Scientists at Coriolis Pharma, together with colleagues at Leiden University in The Netherlands and Ludwig Maxmilians University in Germany, published a paper in the July 2013 issue of the Journal of Pharmaceutical Sciences, in which they described work using RMM and micro-flow imaging to examine the quantitative differentiation of protein particles and silicone oils over a large size range.
Distinguishing between these two entities is pertinent to the development of biopharmaceuticals, in particular for products in prefilled syringes or cartridges where silicone oil may be used as a lubricant in the delivery device. The high accuracy of discrimination using Archimedes for different types of protein particles, and different ratios of protein particle to silicone oil droplets, and also the robustness of the technique were all attributed to the straightforward categorisation of particles and droplets according to buoyant mass.
