| Esco Aster

Ensure Product Quality Throughout Its Lifecycle

Stability data play a critical role in product development, helping sponsors evaluate how product quality attributes change over time under defined storage, handling, and transportation conditions. These studies support the establishment of storage conditions, retest periods, and shelf-life claims while providing important evidence for regulatory submissions.

Esco Aster supports stability and analytical testing programs for a range of biopharmaceutical products and emerging therapeutic modalities. With experience in exosomes and stem cell-related products, our capabilities can be adapted to support additional biologic and biopharmaceutical products through customized analytical and stability testing strategies, including client-transferred methods where appropriate. Stability studies are designed in accordance with applicable ICH Q1A(R2) Stability Testing Guidelines and regulatory expectations, with study parameters tailored to the specific characteristics and development stage of each product.

By integrating stability testing with our Process Development, CMC Development, Analytical Development, and Clinical Manufacturing capabilities, Esco Aster offers a coordinated approach to generating stability data throughout the product development lifecycle, from early-stage development and IND-enabling activities through clinical programs and beyond.

Stability Studies Designed Around Your Product

Stability testing is performed to evaluate how the critical quality attributes (CQAs) of a drug substance or drug product may change over time when exposed to environmental and physical factors such as temperature, humidity, light, and mechanical stress.

These studies are designed to support the determination of appropriate retest periods for drug substances and shelf-life claims for drug products within their intended container-closure systems and recommended storage conditions.

At Esco Aster, stability programs are developed collaboratively with sponsors to define:

Study objectives and duration
Storage conditions
Sampling schedules
Critical quality attributes (CQAs)
Stability-indicating analytical endpoints
Regulatory considerations relevant to the development stage

Each stability strategy is customized to align with product-specific requirements and development goals.

Real-Time Stability Studies

Real-time stability studies involve storing materials under their intended storage conditions and monitoring critical quality attributes at predefined intervals over time.

These studies provide direct evidence of product stability and may be used to support:

Shelf-life determination
Retest period assignment
Storage condition verification
Clinical and regulatory submissions

Accelerated Stability Studies

Accelerated stability studies evaluate product performance under elevated stress conditions, such as increased temperature and humidity, to assess potential degradation pathways within a shorter timeframe.

The resulting data may help sponsors:

Evaluate long-term stability trends
Assess formulation robustness
Support shipping and temperature excursion assessments
Investigate in-use stability
Inform product handling and storage strategies

For clinical trial materials and commercial drug products, long-term studies are typically conducted under intended storage conditions, while shorter-duration studies at elevated temperatures may be incorporated to support product distribution and handling considerations.

Integrated Analytical Testing

Generating meaningful stability data requires more than sample storage alone. Stability-indicating analytical testing is performed at predefined study intervals to assess product quality throughout the study period.

Depending on the product and study objectives, analytical assessments may include:

Identity
Potency
Purity
Viability
Functionality
Safety-related attributes

These analytical methods are frequently developed, optimized, qualified, and validated by Esco Aster as part of our integrated analytical development services, enabling consistency between development, testing, and manufacturing activities.

Partner With Us

Whether you are developing a cell therapy product, viral vector, plasmid DNA platform, exosome-based therapy, or biologic drug product, Esco Aster can work with your team to design a stability program aligned with your product requirements and development objectives.