Services
Services
Stability Studies and Advanced Prediction
Stability Studies and Advanced Prediction
Demonstrate shelf life with phase-appropriate formulated products and predictive modeling.
Demonstrate shelf life with phase-appropriate formulated products and predictive modeling
Why stability studies matter
Why stability studies matter
Stability testing serves as the foundation for demonstrating that a drug product maintains its identity, strength, quality, and purity throughout its intended shelf life under specified storage conditions. These studies support critical decisions about storage requirements, packaging specifications, and shelf-life projections while providing essential data for regulatory submissions and commercial planning. For parenteral drug products, where degradation can directly impact both safety and efficacy, comprehensive stability data represents a critical component of successful development programs.
At Leukocare, stability studies are conducted as systematic exploratory investigations designed to verify formulation performance under both stress and accelerated aging conditions. While our exploratory stability studies are not intended for direct regulatory submission, they serve two essential purposes: identifying the best-performing formulation candidates during development and generating supportive data that complements future GMP stability programs conducted by manufacturing partners.
Our approach goes beyond traditional ICH-based testing to incorporate advanced predictive modeling and accelerated aging techniques that provide earlier insights and more reliable shelf-life projections than conventional approaches.
Stability testing serves as the foundation for demonstrating that a drug product maintains its identity, strength, quality, and purity throughout its intended shelf life under specified storage conditions. These studies support critical decisions about storage requirements, packaging specifications, and shelf-life projections while providing essential data for regulatory submissions and commercial planning. For parenteral drug products, where degradation can directly impact both safety and efficacy, comprehensive stability data represents a critical component of successful development programs.
At Leukocare, stability studies are conducted as systematic exploratory investigations designed to verify formulation performance under both stress and accelerated aging conditions. While our exploratory stability studies are not intended for direct regulatory submission, they serve two essential purposes: identifying the best-performing formulation candidates during development and generating supportive data that complements future GMP stability programs conducted by manufacturing partners.
Our approach goes beyond traditional ICH-based testing to incorporate advanced predictive modeling and accelerated aging techniques that provide earlier insights and more reliable shelf-life projections than conventional approaches.
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 stability testing provides comprehensive evaluation that accelerates formulation decision-making while maintaining scientific rigor and regulatory relevance:
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:
text for spacing
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.
text for spacing
How it works - integrated methodology
Design Exploratory Protocols to Compare Formulations - We design phase-appropriate, ICH-aligned protocols that accelerate formulation decision-making by systematically comparing candidate formulations and identifying optimal options for further development with statistical rigor and appropriate controls.
Related capability: Formulation Development and Optimization
Monitor Stability Trends and Predict Shelf Life - Our systematic approach includes comprehensive statistical trend analysis, confidence interval calculations for reliability assessment, kinetic modeling for enhanced accuracy, and predictive capabilities that support development planning and regulatory strategy development.
Related capability: Forced Degradation Studies
Assess Post-Reconstitution and In-Use Performance - We systematically evaluate product performance after reconstitution and during simulated clinical use, ensuring formulation maintains quality throughout the entire administration process including dilution compatibility and device interactions.
Explore: Primary Packaging Assessment and Particle Characterization
Assess Post-Reconstitution and In-Use Performance - We systematically evaluate product performance after reconstitution and during simulated clinical use, ensuring formulation maintains quality throughout the entire administration process including dilution compatibility and device interactions.
Explore: Primary Packaging Assessment and Particle Characterization
Provide Data to Support GMP Study Planning - Our exploratory stability data provides the scientific foundation for designing efficient GMP stability programs, helping optimize study design, reduce overall development timelines, and ensure regulatory compliance through strategic planning.
Related service: Non-GMP Processing & Small-Scale Manufacturing
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
Who its ideal for?
This service is especially valuable for teams requiring reliable stability data to support formulation selection, regulatory strategy development, and GMP study planning with enhanced predictive capabilities and accelerated decision-making timelines.
It applies across biologics, viral vectors, vaccines, and complex drug products requiring sophisticated stability assessment and predictive modeling capabilities, with particular expertise in challenging modalities where traditional approaches may be insufficient.
Whether you're comparing formulation candidates, establishing shelf-life projections, preparing for regulatory submissions, or optimizing GMP stability study design, our stability studies provide the comprehensive data foundation needed for confident development decisions.
Why partner with Leukocare?
Stability studies at Leukocare are fully embedded into our comprehensive development programs with systematic integration across all related activities. We design phase-appropriate, ICH-aligned protocols that accelerate formulation decision-making while maintaining the scientific rigor and regulatory relevance required for successful development programs. Our systematic approach combines automated data collection systems, statistical analysis capabilities, and quality-driven processes to ensure that results are both reliable and actionable. Our stability testing capabilities encompass the full range of environmental conditions relevant to pharmaceutical products, maintaining temperature-controlled environments from -80°C to +40°C, ICH Q1A-compliant storage chambers, and specialized equipment for photostability testing according to ICH Q1B guidelines. Our mechanical stress testing capabilities include various models for evaluating product behavior under shipping and handling conditions. For enhanced predictive capability, we provide sophisticated regression analysis including both linear and multiple regression approaches, as well as advanced kinetic modeling based on either internal stability data or external data from CMO or GMP laboratory partners, enabling more accurate and reliable shelf-life projections.
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
Partner with Leukocare for tailored, data‑driven solutions that bring your biologics closer to patients.
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 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
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?
