An early assessment of the stability of a protein biopharmaceutical, even during pre-development, can be invaluable. Some products may require extensive redevelopment owing to characteristics such as: non-specific binding to the surfaces of pipettes, vials or within instruments; tendencies toward aggregation or, especially in the case of nebulized proteins to oxidation. During early development, studies focusing on stressed or accelerated stability can provide important indications of potential problems
Stability-indicating assays require the demonstration of the ability of the methods to resolve potential impurities, irrespective of whether these will actually exist. To achieve this, it is necessary to generate and characterize specific degradation products, and to demonstrate that they would indeed be detected. Solvias can generate and purify specific impurities, thus verifying that the methods are adequate for the purpose of demonstrating stability.
In addition to these capabilities, Solvias is also equipped to perform photostability testing according to ICH Q1B guidelines, with respect to:
In relation to late-phase development or established products: Solvias is an experienced provider of cGMP-compliant stability studies performed in ICH-qualified environmental chambers. Effective project management and robust quality systems make Solvias your ideal partner for this activity.