Studies regarding stability testing 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, this can affect the quality, safety, efficacy and biologic activity of the molecule. Therefore, an early assessment of the biopharmaceutical stability with stability testing studies is of prime importance.
PPS offers stability testing programs according to the ICH guidelines Q1A(R2), Q1B and Q5c, as well as expanded programs tailored to the client´s needs. PPS provides scaleable on-site storage capacity and in-house capabilities to evaluate the stability of biopharmaceutical products. Under thoroughly qualified and controlled enviromental conditions (temperature, humidity, light) various types of stability studies as photo stability testing, realtime stability testing, accelerated stability testing, forced degradation studies or in-use stability testing can be performed.
Photostability Testing- Light Exposure, temperature, humidity
Photostability testing at PPS will be performed according to ICH Q1B, option 2 by direct measurement of the accumulated radiation under temperature- and humidity controlled conditions. ICH Q1B, option 2 implies that the same sample is exposed to cool white fluorescent as well as near UV lamp.
Determination of photostability is required throughout the entire development of biopharmaceuticals, starting with drug substance to the final product in its primary and secondary packaging.
Pharma Stability Testing
Pharma Stability testing programs are mostly conducted over several years. It is vital, that all analytical techniques perform in a robust manner, in order to prevent out-of-specification (OOS), out-of-exspectation (OOE), or out-of –trend-results (OOT), which would put the study or a potential product release at risk.
During the course of a pharma stability testing study, potential degradations/modifications can occur and have to be characterized. PPS ist experienced in assessing these degradation pathways and biochemical modifications e.g. by mass spectrometry. Those data strongly support the definition of critical quality attributes (CQA).
The requirements for a stability study are described in ICH Topic Q1A (R2) – 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 diverse range of analytical techniques is often required to determine the stability profile of a biopharmaceutical product, some of which are listed in the following table.
Realtime stability testing
Data sets obtained from realtime stability testing procedures ranging from stability data for development up to long-term stability studies of authorized market products. PPS supports all major milestones oft he analytical lifecycle.
Protagen Protein Services (PPS) is a world leading CRO and recognized expert for analytical services in protein science regarding characterization, method development, validation and routine testing of antibodies, proteins, vaccines and other formates of biopharmaceuticals. Our sites are equipped with modern, state-of-the-art equipment for the analytical characterization of biopharmaceuticals regarding structure, purity, chemical modification, aggregation, particle formation, thermal stability e.g.. We offer service modules for analytcal support from research to approval regarding:
- Clone Selection & Process Development
- Extendend Characterization & Comparability
- Stability & Release
Protagen Protein Services (PPS) is a world leading CRO and recognized expert for analytical services in protein science. More than 20 years of market experience and the comprehensive spectrum of validated analytical methods ensure the highest quality for customers in the pharmaceutical, biotech and life science industry.
PPS supports Biosimilar developers with a broad range of analytical methods and consulting in achieving and demonstrating Biosimilarity