USP <787> – Solution to the problem of viscous therapeutic protein solutions

Those who have ever dealt with particle measurement of therapeutic protein solutions understand the problem: there is extremely little sample fluid available, because it is very expensive. In addition, the samples are usually very viscous.

How can reliable values be measured without diluting the samples or resorting to the subjective and time-consuming microscopic analysis procedure?

Analyses of pharmaceutical liquids are usually performed according to the international pharmaceutical books (Pharmacopoeia), such as the United States Pharmacopoeia (USP) or the European Pharmacopoeia. There, the automatic laser-optical measuring method is mentioned as the preferred method for the analysis of invisible particles in infusion solutions, parenteral agents, pharmaceutical suspensions and intravenous or ophthalmic solutions. In the case of problematic sample properties, such as too high a viscosity, reference is made to the microscopic measuring method, which entails other problems. It is much more time-consuming and complicated to use and therefore ultimately considerably more expensive. In addition, manual microscopy is highly dependent on the user, which leads to subjective measurement results.

PAMAS SBSS Small Volume

PAMAS has looked at this fundamental problem and developed the solution in the PAMAS SBSS Small Volume: a laser-optical particle counter that can reliably measure the smallest sample volumes of highly viscous liquids. Due to the unique pressure measurement method, dilution of the sample is not necessary. The air bubbles that would disturb the measurement can be removed from the sample with the integrated vacuum function.

Additionally, if the sample contains a gas that is part of the sample and therefore must not escape (because this could e.g. influence the particle population in size and/or number), then in that case the sample can be measured under pressure with the SBSS, while keeping the gas in the sample solution.

With the SBSS Small Volume, PAMAS currently offers the only device of this type on the market.

www.pamas.de