Team also publishes paper examining ability to distinguish between protein aggregates and oil droplets in biopharmaceutical formulations

Coriolis Pharma (Martinsried, Germany) has become the first pharmaceutical contract research organization in the world to routinely use Archimedes, a new analytical instrument supplied by Malvern Instruments. Coriolis Pharma specializes in formulation development for biopharmaceuticals such as proteins, peptides and vaccines and offers a wide variety of services to support product development.

Archimedes is a new system that uses the technique of resonant mass measurement (RMM) to detect and accurately count particles from 50 nm to 5 µm in diameter, and to measure their buoyant mass, dry mass and size. It has applications in the quantitative characterization of protein aggregates in the size range currently of new regulatory interest, from 0.2 µm to 2 µm diameter, where aggregates are considered to have a high likelihood of eliciting an unwanted immune response. Uniquely for this size range, Archimedes distinguishes between proteinaceous material and contaminants such as silicone oil.

“The teams at Coriolis Pharma have extensive expertise in protein analysis, especially in the field of protein aggregation and degradation, and were early to recognize the benefits of applying resonant mass measurement within our formulation development regimes,“ said Dr. Andrea Hawe, CSO from 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."

In the July 2013 issue of the Journal of Pharmaceutical Sciences, scientists at Coriolis Pharma, together with colleagues at Leiden University in The Netherlands and Ludwig Maxmilians University in Germany, published a paper reporting 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 categorization of particles and droplets according to buoyant mass.

“Archimedes is now part of our routine offering for clients seeking support in formulation development. In addition we can run samples as part of feasibility studies for future work or as standalone projects,” continued Dr. Andrea Hawe.  “Having this technique available means we are able to offer more extensive protein characterization services to our clients that help them in the drive to more rapidly develop and commercialize new therapeutic solutions." 

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