We understand that early assessment of a protein biopharmaceutical’s stability can be invaluable, even during pre-development. For drug substances and drug products all stability aspects can be monitored including long term and accelerated stability studies, in use studies, short term temperature excursion studies, and forced degradation studies according to ICH guidelines Q5C and Q1B.
This can flag up problematic characteristics such as: non-specific binding to pipettes, vials or within instruments; tendencies toward aggregation or oxidation (especially in the case of nebulized proteins).
Studies focusing on stressed or accelerated stability can also provide important early indications of potential problems that may lead to extensive product redevelopment.
Stability-indicating assays need to demonstrate the method’s ability to resolve potential impurities, irrespective of whether these will actually exist. To achieve this, specific degradation products must be generated and characterized to show that they can be detected. Solvias can generate and purify such specific impurities, thus verifying that the methods are adequate for the purpose of demonstrating stability.
For late-phase development or established products, we are 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.