Find and overcome critical degradation pathways of your drug substance through forced degradation studies

Stability studies and Forced degradation studies

Forced degradation studies (also known as stress testing) play a central role in almost all development phases from preformulation studies and late-stage formulation development. It is essential to understand the criticality of certain types of stress for the drug substance and to identify the most robust and stable formulation during development.

Relevant stress conditions that do not over- nor under-stress the drug substance are the foundation of meaningful stress testing. Our expert scientists possess two important tools to achieve this: pre-tests and a lot of experience. At Coriolis we can apply the knowledge gained in hundreds of projects to quickly obtain optimal test conditions for your molecule, reflecting its major degradation pathways and assessing its critical quality attributes (CQA).

The following categories of forced degradation are frequently developed and performed by our scientists:

Freeze-thaw
Temperature excursion
Pumping
Stirring
Shaking/agitation
Drop
Light exposure
Chemical spiking
pH shift
Oxidation

Development of stability indicating analytical methods

The presence of a stressed and (partially) degraded sample is also the basis of any comprehensive analytical method development that allows for the quantification of undesired by-products. A sensitive and orthogonal characterization of the drug product by using stability indicating and phase-appropriate analytical methods is important. We perform a large portfolio of analysis in-house and develop dedicated methods for each technique.

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Forced degradation studies tailored to your drug product

Forced degradation studies will be tailored to your specific API, development phase, production and handling procedures, and target product profile (TPP), and is backed by many years of experience with similar drug substances. Click on a product type to explore our entire portfolio of specialized development and analytical services.

Your product

Antibody or related product

Quality & biosafety level of this service

We provide all our services with the highest quality standards. Each project is carried out by experienced scientists and every report or data presentation is comprehensively checked by a scientific reviewer. We offer this service with the following quality and biosafety level:

R&D level

We offer this service under R&D. Our GRP system assures highest-quality research standards.

Up to biosafety level S2

This service can be applied to nucleic-acids, viruses, cells, viral vectors incl. lentiviruses and more.

Our services related to forced degradation studies

Evaluating the stability of a drug product under stress conditions is often accompanied by other activities such as preformulation studies and the implementation of stability indicating analytical methods.

Preformulation studies

We devise preformulation studies for candidate selection and to support the development of an initial drug substance formulation for preclinical trials.
In close collaboration with your discovery research, our scientists focus on characterizing the physico-chemical properties of the lead molecule(s) by employing low-volume and high-throughput methods to determine the sensitivity of the lead molecule(s) to pharmaceutically relevant stress conditions.

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We offer this service under R&D and GMP and up to Biosafety Level S2

Analytical method development

A sensitive and orthogonal characterization of the drug product by phase-appropriate analytical methods is critical for a well-designed forced degradation study.

Coriolis offers a large in-house portfolio of analysis techniques in various categories including aggregate and particle characterization, chemical and higher order structure analysis, and many more. Our expert scientists develop dedicated and stability indicating methods for each technique.

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We offer this service under R&D and GMP and up to Biosafety Level S2

Our know-how related to forced degradation studies

Coriolis is a science-driven service provider. We perform internal research projects with academic and industrial partners to develop new technologies and create in-depth knowledge, which directly benefits our client projects. Our internal Unit Science & Technology, hosting PhD candidates and Postdocs, also actively contributes to the scientific community with numerous peer-reviewed publications each year. Explore our latest publications, articles, and webinars:

Knowledge items

Publication

Advanced Therapy Medicinal Products: What's in a Name?

Jiskoot W.

Publication

Modulated Scanning Fluorimetry Can Quickly Assess Thermal Protein Unfolding Reversibility in Microvolume Samples

Hristo L Svilenov, Tim Menzen, Klaus Richter, Gerhard Winter

Publication

What makes polysorbate functional? Impact of polysorbate 80 grade and quality on IgG stability during mechanical stress.

Grabarek AD, Bozic U, Rousel J, Menzen T, Kranz W, Wuchner K, Jiskoot W, Hawe A.

Publication

Shifting Paradigms Revisited: Biotechnology and the Pharmaceutical Sciences

Crommelin D, Nastribattusta E, Hawe A, Hoogendoorn K and Jiskoot W.

Publication

Towards heat-stable oxytocin formulations: analysis of degradation kinetics and identification of degradation products.

Hawe A, Poole R, Romeijn S, Kasper P, van der Heijden R, Jiskoot W.

Publication

Development of HSA-free formulations for a hydrophobic cytokine with improved stability.

Hawe A, Friess W.

Publication

Analytical approaches to assess the degradation of therapeutic proteins

Filipe V, Hawe A, Carpenter JF and Jiskoot W.

Publication

No Touching! Abrasion of Adsorbed Protein Is the Root Cause of Subvisible Particle Formation During Stirring.

Sediq AS, van Duijvenvoorde RB, Jiskoot W, Nejadnik MR.

Publication

Shaken, not stirred: mechanical stress testing of an IgG1 antibody.

Kiese S, Papppenberger A, Friess W, Mahler HC.

Publication

Structural properties of monoclonal antibody aggregates induced by freeze-thawing and thermal stress.

Hawe A, Kasper JC, Friess W, Jiskoot W.

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Our other services

Coriolis provides a wide range of science-driven and tailor-made solutions for research, development, and analytical challenges. Explore our other services and learn more about how we can support your drug development program. Together, we can make future therapies available to patients and improve the quality of life for humankind.