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Stability Testing and Forced Degradation Stress Tests - Proactive Risk Management

Protagen Protein Services


Whereas the durability of many consumables, have a strong tendency to decrease, stability is and remains a crucial factor for pharmaceuticals. That is why the identification and elimination of factors, which put long-term stability at risk, is central during development – and an important requirement concerning the product’s quality.


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.

Tailored Approaches

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.”

About Protagen Protein Services GmbH (PPS):

Protagen Protein Services (PPS) is a world leading CRO and a recognized expert in mass spectrometry methods for analytical services in protein science. Over 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. For developing new biological entities (NBEs) PPS supports customer approaches by all-in-one-hand service with including full analytical support, complete documentation and outstanding project management to gain market success.

Contact:
Tobias Timtner
Marketing Manager
Protagen Protein Services GmbH
Inselwiesenstraße 10
74076 Heilbronn, German

Tel.: +49 7131 74504-
Fax: +49 7131 74 504-299
phone +49 231 9742 61 00
email contact@protagenproteinservices.com
web www.protagenproteinservices.com
email Protagen Protein Services (GmbH), Inselwiesenstraße 10, D-74076 Heilbronn
 
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