Studies regarding stability testing are a fundamental part of the development of a biopharmaceutical. Proteins are sensitive to environmental variables. Changes in biopharmaceutical stability because of aggregation, degradation, physical or chemical instability can alter protein folding and structure. Consequently, this can influence the quality, safety, efficiency and biologic activity of this molecule. Therefore, an early evaluation of the biopharmaceutical stability with equilibrium testing studies is of prime importance.PPS provides stability testing applications according to the ICH Guidelines Q1AR2, Q1B and Q5c, in addition to expanded programs tailored to the customer ´s needs. PPS provides saleable onsite storage capacity and in-house capacities to assess the stability of biopharmaceutical products. Under thoroughly capable and controlled environmental conditions temperature, humidity, light various kinds of stability studies as picture stability testing, Realtime stability testing, accelerated stability testing, forced degradation studies or in-use stability testing can be carried out.
Photostability testing at PPS will be performed based on ICH Q1B, option 2 by direct measurement of the accumulated radiation under temperature- and humidity controlled conditions. ICH Q1B, choice 2 suggests that the identical sample is subjected to cool white fluorescent in addition to near UV lamp.Determination of photostability is required through the Entire development of biopharmaceuticals, beginning with drug substance to the last product in its primary and secondary packaging.Pharma Stability testing applications are mostly conducted over several years. It is vital, that all analytical techniques perform in a strong fashion, to be able to stop out-of-specification OOS, out-of-expectation, or out of trend-results, which would set the study or a possible product release in danger.
Throughout the course of a pharma Stability Testing analysis, possible Degradations/modifications can occur and need to be characterized. PPS its experienced in analysing these degradation pathways and biochemical alterations e.g., by mass spectrometry. Those data strongly support the definition of critical quality characteristics.The prerequisites for a stability study are described in ICH Topic Q1A Stability Testing of new Drug Substance and Products, ICH Q1B – Stability Testing: Photostability Testing of New Drug Substances and Products and ICH Q5C — Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products.A Wide Range of analytical methods is often required to Determine the stability profile of a biopharmaceutical item, a few of which are recorded in the following table.