Phase Appropriate Release & Stability Testing
Ensure your pharmaceutical product’s quality, safety, and efficacy by performing thorough release testing and stability studies. With a variety of storage conditions and testing capabilities, our team provides insights on your product that are then utilized to determine recommended storage conditions, retest intervals, and establish shelf-life.
Early and robust stability testing helps assess the developability of an API drug substance or drug product formulation, while less intensive stability testing serves as a reference point for the ongoing development program. Our team is adaptable to your needs and conducts formal ICH stability studies following provided methods, compendial methods, or methods developed and validated by us. We use a formal stability tracking system that fully complies with regulatory processes.
Stability Testing
Our stability testing services inform your drug product’s shelf life, suggest appropriate storage conditions before and after opening, and identify potential degradation or quality concerns. These insights also help select packaging and closure systems and support the development of stability-indicating analytical methods.
Identify the appropriate storage conditions for your product by testing against our variety of parameters. No matter the needs and conditions of your project, we have the space to execute.
- Total GMP storage capacity > 25,000 cu. Ft.
- -80°C, Reach-In
- -20°C, Reach-In
- 5°C, Walk-In
- 25°C/60% RH, Walk-In
- 30°C/65% RH, Walk-In
- 30°C/75% RH
- 30°C/70% RH
- 40°C/75% RH, Walk-In
- 40°C/10% RH
- 50°C/10% RH
- 37°C, 45°C and 50°C Accelerated Aging
- Custom Conditions and Reach-In Chambers
- Photo-Stability, ICH Q1b (Option 2)
- Continuous Monitoring and Emergency Power Systems
Quickly gain insight into the long-term stability of your drug product with accelerated stability testing. We subject your drug substance or product to accelerated conditions, manipulating temperature, humidity, and light to expedite stress-induced reactions. Simultaneously, we gather comparative data under normal conditions for parallel analysis.
Understand your drug substance or drug product’s behavior under elevated conditions to predict the shelf life under normal conditions. We apply conditions that are more moderate than accelerated stability studies but more severe than long-term stability studies. These studies use Arrhenius-based prediction models to understand the stability profile of your compound.
Gather essential data about your drug substance or drug product with long-term stability studies. This testing is standard protocol to assess a drug product’s behavior under intended storage conditions to verify safety and efficacy data over its shelf life. Regulatory filings require this data for approval. Our GMP labs have adequate resources to stage and execute these studies within regulatory compliance to advance your drug development program.
Evaluate how your drug substance or drug product behaves in real-world scenarios by conducting in-use stability studies under conditions reflecting their intended use. Examples of these studies include preparation and storage of formulations for PK studies, drug delivery through a syringe, and/or chemical compatibility with a medical device. We apply the intended storage, drug delivery, and patient application conditions to gather performance and chemical stability data.
Release Testing
Release testing is an essential activity to ensure newly manufactured batches are consistent with specifications and meet all applicable quality standards. Predetermined release tests are executed according to established protocols and results are embedded in formal certificates of testing. If required, we perform the entire activity under GLP with full utilization of our Pace® Life Sciences Quality system.
Our team supports comprehensive quality control specifications during release testing based on your drug product’s intended use and relevant regulatory requirements. We provide accurate, reproducible data to ensure the tested batch is consistent with the expected formulation.
- Identity
- Potency
- Purity & Impurities
- Physical Properties
- Physicochemical Properties
- Presentation Attributes
- Microbiology
- Safety
We outline and apply clear, well-defined release specifications to your drug product based on the quality control specifications and progression of your program. Testing the material for its predefined attributes determines whether a batch is suitable for release to its intended application.
- Marketing Authorization
- Clinical Trial Dossier
Our team develops and validates analytical methods to ensure accurate and reproducible results specific to your drug product. The applied methods are developed to be fit for purpose, yet ready to be validated if necessary.
Integrated Laboratory Services
When your team needs additional CDMO support, our scientists are ready. Our state-of-the-art facilities and highly trained experts can add power to your project.