Stability studies are a fundamental part of the development of a biopharmaceutical. Proteins are sensitive to environmental factors: Changes in biopharmaceutical stability due to aggregation, degradation, chemical or physical instability can alter protein folding and structure. Consequently, the quality, the safety, the efficacy and overall the biologic activity of the molecule can be affected. Therefore, an early assessment of the biopharmaceutical’s stability is of primary importance.
Forced degradation plays a key role in stability testing procedures. Protagen Protein Services (PPS) applies forced degradation studies to protein pharmaceuticals during different development steps, helping to understand the degradation pathways of the molecule, identifying the critical quality attributes and the potential consequences a degradation effect can have for biopharmaceutical’s safety and efficacy as early as possible.
Evaluating Effects of Environmental Factors
Within forced degradation studies, samples are subjected to stressors like light, agitation, high temperatures, oxidative- and pH-stress. Thereby a variety of naturally occurring degradation factors are simulated in a quickened mode. By this means, the degradation behavior of the biopharmaceutical’s components can efficiently be tracked. Extensive analytical characterization is an integral part of the forced degradation testing procedures.
Long-term expertise in stress testing combined with high analytical capabilities provides reasonable assurance that the molecule meets the required persistence. PPS offers stability programs according to the ICH guidelines Q1A(R2), Q1B and Q5C, as well as expanded programs tailored to the project’s needs, so that under thoroughly qualified and controlled environmental conditions various types of stability studies can be performed, targeting all major milestones of the analytical lifecycle. Beyond providing ideal storage, PPS provides great analytical in-house capabilities for not only stability-indicating methods, but also various methods for extended characterization.
Managing and processing individual packages for molecule stressing needs to be tailored to the molecule, mode of action, and prior knowledge of critical quality attribute.PPS has performed multiple projects in this field . “The successful development of a pharmaceutical product can only be ensured by monitoring its optimally controlled production and by anticipating undesired modifications”, says Ulrike Konrad, Head of Business Development. “Our comprehensive analysis and stability studies will help to design a biopharmaceutical remaining within its specifications as outlined by global guidelines.”