Services
Services
Forced Degradation Studies
Forced Degradation Studies
Understand degradation pathways to build more stable products.
Understand degradation pathways to build more stable products
Why forced degradation matters
Why forced degradation matters
Forced degradation studies represent a cornerstone of modern drug product development, providing essential insights into molecular behavior under accelerated stress conditions. By systematically exposing molecules to controlled stress environments, these studies reveal critical degradation pathways, identify chemical liabilities, and uncover stability risks that might not be apparent under normal storage conditions, enabling formulation scientists to develop more robust formulations and establish appropriate analytical monitoring strategies.
Understanding how your molecule degrades under stress provides invaluable insights for formulation design, allowing you to identify and address potential problems early in development when solutions are still feasible and cost-effective. This knowledge becomes particularly critical when developing stability-indicating analytical methods and establishing appropriate storage and handling recommendations.
Forced degradation studies represent a cornerstone of modern drug product development, providing essential insights into molecular behavior under accelerated stress conditions. By systematically exposing molecules to controlled stress environments, these studies reveal critical degradation pathways, identify chemical liabilities, and uncover stability risks that might not be apparent under normal storage conditions, enabling formulation scientists to develop more robust formulations and establish appropriate analytical monitoring strategies.
Understanding how your molecule degrades under stress provides invaluable insights for formulation design, allowing you to identify and address potential problems early in development when solutions are still feasible and cost-effective. This knowledge becomes particularly critical when developing stability-indicating analytical methods and establishing appropriate storage and handling recommendations.
Partner with Leukocare for tailored, data‑driven solutions that bring your biologics closer to patients.
Let’s Build the Right Formulation — Together
Let’s Build the Right Formulation — Together
Let’s Build the Right Formulation — Together
Partner with Leukocare for tailored, data‑driven solutions that bring your biologics closer to patients.
Let’s Build the Right Formulation — Together
What you get
Our forced degradation studies provide comprehensive degradation characterization that directly informs formulation optimization, analytical method development, and regulatory strategy:
Our approach provides a consolidated readout that is practical,
actionable and designed to accelerate decision-making.
Instead of generic risk notes, you receive outputs that can directly inform
experimental design, development priorities and clinical planning:
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Let’s Build the Right Formulation — Together
Partner with Leukocare for tailored, data‑driven solutions that bring your biologics closer to patients.
Let’s Build the Right Formulation — Together
Partner with Leukocare for tailored, data‑driven solutions that bring your biologics closer to patients.
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How it works - integrated methodology
How it works - integrated methodology
Design and Execute Molecule-Specific Studies - We design degradation studies tailored to your molecule type, ntended use, and regulatory requirements, providing maximum insight while conserving valuable drug substance material through strategic experimental design and efficient analytical approaches.
Related capability: Developability Assessment
Identify Degradation Pathways and Define Critical Quality Attributes - Our systematic approach identifies the most relevant degradation mechanisms for your molecule, providing the scientific foundation for formulation optimization and analytical method development activities while establishing appropriate monitoring strategies.
Related capability: Formulation Development and Optimization
Support Analytical Method Development and Validation - Forced degradation results directly inform development of stability-indicating analytical methods by identifying the degradation products that must be monitored throughout product development and manufacturing while providing appropriate stress conditions for method qualification.
Explore: Data Science Services
Use Findings to Guide Formulation Strategies - We translate degradation study findings into specific formulation recommendations and optimization strategies, helping you build stability into your product from the earliest development stages while providing scientific rationale for excipient selection and process parameters.
Related service: Biopharmaceutical Analytical Services
Manufacturability & administrability - We analyze adsorption, pH-jump effects, high-concentration viscosity and container-closure interactions to ensure that what looks feasible in silico also works in practice. This step bridges stability with usability.
Related service: Primary Packaging Assessment
Stress Testing Capabilities -
A - Environmental Stress Condition
B- Chemical Stress Applications
Manufacturability & administrability - We analyze adsorption, pH-jump effects, high-concentration viscosity and container-closure interactions to ensure that what looks feasible in silico also works in practice. This step bridges stability with usability.
Related service: Primary Packaging Assessment
Support Analytical Method Development and Validation - Forced degradation results directly inform development of stability-indicating analytical methods by identifying the degradation products that must be monitored throughout product development and manufacturing while providing appropriate stress conditions for method qualification.
Explore: Data Science Services
Who it`s ideal for?
This service is especially valuable for teams developing complex biologics requiring understanding of degradation mechanisms and regulatory-compliant analytical methods, with expertise spanning diverse therapeutic modalities and regulatory requirements.
It applies across monoclonal antibodies, peptides, small molecules, viral vectors, and other therapeutic modalities requiring systematic degradation characterization, mechanistic understanding, and robust analytical method development for regulatory compliance.
Whether you're designing formulation strategies, developing analytical methods, preparing regulatory submissions, or establishing manufacturing control strategies, our forced degradation studies provide the mechanistic foundation and experimental evidence needed for successful development and regulatory approval.
Why partner with Leukocare?
Leukocare applies forced degradation studies strategically throughout formulation development programs with a systematic approach that combines experimental rigor with mechanistic understanding. We design comprehensive degradation protocols tailored to your specific molecule type and intended use, utilizing stress conditions including elevated temperature, freeze/thaw cycling, light exposure, agitation, and rotation to provide a complete picture of molecular stability behavior.
Our systematic approach ensures that degradation studies generate maximum value for your development program while supporting regulatory requirements and providing actionable insights for formulation optimization. We integrate forced degradation results with molecular modeling insights and formulation development activities to create comprehensive understanding of stability relationships and optimization opportunities.
The combination of our experimental expertise with computational insights ensures that degradation studies provide both immediate practical value and long-term strategic guidance for your development program.
We provide actionable outputs, not just
observations. Our team integrates
structural biology, data science
and formulation development to deliver a single coherent story—risk scores, liabilities and
hypotheses that directly inform design of
experiments and decision points. Beyond
assessment, we offer connected services
so your program can move seamlessly into
optimization, extended stability packages
and small-scale non-GMP manufacturing
without losing momentum.
See: Non-GMP Processing &
Let’s Build the Right Formulation — Together
We model monoclonal antibodies, bispecific formats, antibody-drug conjugates, fusion proteins, enzymes, therapeutic peptides, and other engineered biologics, with specialized capabilities for complex conjugates and novel protein architectures.
We model monoclonal antibodies, bispecific formats, antibody-drug conjugates, fusion proteins, enzymes, therapeutic peptides, and other engineered biologics, with specialized capabilities for complex conjugates and novel protein architectures.
Let’s Build the Right Formulation — Together
We model monoclonal antibodies, bispecific formats, antibody-drug conjugates, fusion proteins, enzymes, therapeutic peptides, and other engineered biologics, with specialized capabilities for complex conjugates and novel protein architectures.
FAQ
Which molecule classes do you work with most often?
What is SMART Formulation® and how does it differ from classic screening?
How long does a typical formulation project take?
Can you supply non-GMP material for pre-clinical studies?
FAQ
Which molecule classes do you work with most often?
What is SMART Formulation® and how does it differ from classic screening?
How long does a typical formulation project take?
Can you supply non-GMP material for pre-clinical studies?
Proof and Resources
Explore our developability expertise through our webinars
New Publication
Identification of relevant analytical methods for adeno-associated virus stability assessment during formulation development
Read it now!
New Publication
Identification of relevant analytical methods for adeno-associated virus stability assessment during formulation development
Read it now!
New Webinar
Smart Drug Product Development: Rational formulation designs for highly concentrated biologics
Wednesday, June 25, 2025 · 4:00 p.m. Amsterdam (GMT +2:00)
Latest News
Jun 30, 2025
Identification of relevant analytical methods for adeno-associated virus stability assessment during formulation development
Formulation of adeno-associated viral (AAV) vectors requires analytical methods that are predictive of stability, use minimal material, and allow high-throughput testing—criteria that are often difficult to meet. This exploratory study assessed several analytical techniques for their ability to predict or indicate AAV stability. Two methods emerged as particularly promising: extrinsic differential scanning fluorimetry with SYBR Gold for genome release detection, and nano differential scanning fluorimetry for capsid stability. Size-exclusion chromatography with multi-angle light scattering and UV was also effective for monitoring particle size and genome load.
May 30, 2023
An exploratory study on the effect of mechanical stress on particle formation in monoclonal antibody infusions
Monoclonal antibody infusions face risks of particle formation from transport stress, especially at low concentrations. Studies show pembrolizumab and bevacizumab are most affected, highlighting the need to minimize storage time, vibration, and syringe particle entry.
Oct 12, 2022
Efficient stabilization of therapeutic hepatitis B vaccine components by amino-acid formulation maintains its potential to break immune tolerance
JHEP Reports. 2023 Feb; 5(2): 100603
SACHERL J. ET AL: Efficient stabilization of therapeutic hepatitis B vaccine components by amino-acid formulation maintains its potential to break immune tolerance
Nov 9, 2018
Rentschler Biopharma SE / LEUKOCARE AG/ Informa Pharma Intelligence
Rentschler Biopharma SE / LEUKOCARE AG/ Informa Pharma Intelligence
"2018 Survey- Formulation in the Drug Product Development Process": 2018 Survey ‘Formulation in the Drug Product Development Process’, based on research from Informa Pharma Intelligence
Apr 20, 2010
Jun 30, 2025
Identification of relevant analytical methods for adeno-associated virus stability assessment during formulation development
Formulation of adeno-associated viral (AAV) vectors requires analytical methods that are predictive of stability, use minimal material, and allow high-throughput testing—criteria that are often difficult to meet. This exploratory study assessed several analytical techniques for their ability to predict or indicate AAV stability. Two methods emerged as particularly promising: extrinsic differential scanning fluorimetry with SYBR Gold for genome release detection, and nano differential scanning fluorimetry for capsid stability. Size-exclusion chromatography with multi-angle light scattering and UV was also effective for monitoring particle size and genome load.
May 30, 2023
An exploratory study on the effect of mechanical stress on particle formation in monoclonal antibody infusions
Monoclonal antibody infusions face risks of particle formation from transport stress, especially at low concentrations. Studies show pembrolizumab and bevacizumab are most affected, highlighting the need to minimize storage time, vibration, and syringe particle entry.
Oct 12, 2022
Efficient stabilization of therapeutic hepatitis B vaccine components by amino-acid formulation maintains its potential to break immune tolerance
JHEP Reports. 2023 Feb; 5(2): 100603
SACHERL J. ET AL: Efficient stabilization of therapeutic hepatitis B vaccine components by amino-acid formulation maintains its potential to break immune tolerance
Nov 9, 2018
Rentschler Biopharma SE / LEUKOCARE AG/ Informa Pharma Intelligence
Rentschler Biopharma SE / LEUKOCARE AG/ Informa Pharma Intelligence
"2018 Survey- Formulation in the Drug Product Development Process": 2018 Survey ‘Formulation in the Drug Product Development Process’, based on research from Informa Pharma Intelligence
Apr 20, 2010
Jun 30, 2025
Identification of relevant analytical methods for adeno-associated virus stability assessment during formulation development
Formulation of adeno-associated viral (AAV) vectors requires analytical methods that are predictive of stability, use minimal material, and allow high-throughput testing—criteria that are often difficult to meet. This exploratory study assessed several analytical techniques for their ability to predict or indicate AAV stability. Two methods emerged as particularly promising: extrinsic differential scanning fluorimetry with SYBR Gold for genome release detection, and nano differential scanning fluorimetry for capsid stability. Size-exclusion chromatography with multi-angle light scattering and UV was also effective for monitoring particle size and genome load.
May 30, 2023
An exploratory study on the effect of mechanical stress on particle formation in monoclonal antibody infusions
Monoclonal antibody infusions face risks of particle formation from transport stress, especially at low concentrations. Studies show pembrolizumab and bevacizumab are most affected, highlighting the need to minimize storage time, vibration, and syringe particle entry.
Oct 12, 2022
Efficient stabilization of therapeutic hepatitis B vaccine components by amino-acid formulation maintains its potential to break immune tolerance
JHEP Reports. 2023 Feb; 5(2): 100603
SACHERL J. ET AL: Efficient stabilization of therapeutic hepatitis B vaccine components by amino-acid formulation maintains its potential to break immune tolerance
Nov 9, 2018
Rentschler Biopharma SE / LEUKOCARE AG/ Informa Pharma Intelligence
Rentschler Biopharma SE / LEUKOCARE AG/ Informa Pharma Intelligence
"2018 Survey- Formulation in the Drug Product Development Process": 2018 Survey ‘Formulation in the Drug Product Development Process’, based on research from Informa Pharma Intelligence
Apr 20, 2010