Accelerated stability studies

Faster stability insights. Reduced risk. Greater confidence in your product.

Accelerated stability studies help you generate meaningful stability data in months rather than years – enabling earlier decision-making, reduced development risk and a more efficient path to commercialisation.

By assessing products under elevated temperature and humidity conditions in line with ICH guidelines, these studies simulate long-term storage over a shorter timeframe. This provides insight into degradation pathways, packaging performance, and temperature sensitivity while real-time studies are still ongoing.

Biofortuna colleague in PPE walking alongside accelerated stability chambers with clipboard
Biofortuna colleague in PPE accessing accelerated stability chambers

Integrated services that simplify your stability strategy

We provide flexible, end-to-end stability solutions tailored to your product and development stage – helping you reduce complexity and maintain momentum.

Development and manufacturing

Streamline your workflow by keeping development, manufacturing and stability trials under one roof. This reduces sample handling, eliminates unnecessary transport, and minimises delays.

Comprehensive testing

We perform in-depth analysis to evaluate your product’s integrity and functionality across its shelf life, including physical performance, freeze-drying quality and functional performance.

Simulated transport conditions

We design and execute studies that replicate shipping environments to ensure your product maintains stability and performance beyond the laboratory.

Product retention

Controlled product retention allows for ongoing evaluation of functional, physical and chemical attributes to support quality, compliance and shelf-life validation.

Stability sample storage

Specialist storage under accelerated conditions ensures your samples are maintained in stable, monitored environments throughout your studies.

Why accelerated stability studies matter

Accelerated stability studies allow you to identify potential issues early, optimise your product, and avoid costly delays later in development.

Earlier insight into shelf life

Accelerated conditions enable you to predict tentative shelf-life in a shorter timeframe. For many products, ICH guidelines recommend testing at 40°C/75% RH for 6 months to support these assessments.

Early identification of formulation and packaging risks

Elevated temperature and humidity accelerate chemical and physical changes, helping reveal potential failures sooner – reducing wasted research and enabling timely optimisation.

Faster access to stability data

Rather than waiting years for real-time studies alone, accelerated testing provides meaningful degradation trends within months, supporting faster decision-making.

Biofortuna colleague entering stability chambers in PPE with a crate of samples

A complete stability strategy, from development to delivery

We support more than just stability testing, offering integrated assay development, manufacturing, and cell-based quality control (QC) assay development to ensure consistent performance across environments.

By combining accelerated and real-time stability studies with manufacturing expertise and QC development, we help you reduce risk, improve efficiency and bring your product to market with confidence.

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