Stability Testing
Stability testing is used by pharmacologists to detect changes in properties, purity and potency of formulated drug products over time. Stability is part of a biotherapeutic’s quality target product profile under QbD paradigm. The results of stability testing help scientists to understand the critical quality attributes (CQAs) of drug products under different conditions. BOC Sciences provides the necessary knowledge to establish a well-defined testing program designed to confirm the stability of your biological products. We ensure our clients can receive comprehensive regulatory updates and a deep understanding of all the key product parameters that affect the stability of your biologic product.
Figure 1. Stability studies during a product life-cycle. (Ammann, C. 2011)
Our Services
To make it easier and better for researchers, BOC Sciences provides stability testing service in a competitive fashion. We have provided a more efficient way to increase the number of new drugs, greatly shorten the R&D cycle, and reduce the development costs. We have developed well-established stability testings to identify degradation pathways and to determine shelf lives and storage conditions for different biologic products. The types of tests and bioassays used to monitor purity, identity, potency, quality and safety depend on the product type and intended use. BOC Sciences offers stability testing programs according to the ICH guidelines Q1A(R2), Q1B and Q5c, as well as expanded programs tailored to the client’s needs. Our consultants specializing in assay development and related strategies can help prevent possible problems.
- Real-time and Accelerated Stability Testing
We use this two tests to determine shelf life: In the real-time stability test, the product is stored under recommended storage conditions and monitored until it does not meet product specifications. In accelerated stability testing, the product is stored at elevated stress conditions such as high temperature and/or humidity. Moreover, our experts can predict the degradation at different storage conditions
- Forced Degradation Studies
Forced degradation studies, also known as stress testing, play a central role in formulation development, manufacturability assessment, and the development of stability-indicating analytical test methods. Stress testing produces representative samples to assess the stability of drug products, provide information about possible degradation pathways, and demonstrate the stability-indicating capability of the analytical procedure applied. In stability studies for forced degradation projects, we use extreme storage conditions including acids, bases, peroxides, temperature and light to increase the rate of degradation. Finally, we provide information on product breakdown and degradation pathways to help our customers improve formulations and determine storage conditions to control product stability, which is important in early drug development
- Long-term Stability Studies
For biopharmaceutical products, long-term stability studies are conducted under the intended storage conditions, with shorter duration studies at higher temperatures to support in-use stability and shipping conditions
Figure 2. Pre-analytical variables for plasma and serum samples. (Stevens, V. L.; Hoover, E. et al. 2019)
- Regular and On-going Stability
At BOC Sciences, on-going studies are only done for commercial batches
- In-use Stability
In-use stability studies are typically conducted for multi-dose products such as topicals (gels, creams, lotions, etc.), eye and ear drops, and oral solutions. We begin in-use studies at one or more time points in our regular studies, and in-use studies typically last several days or weeks
- Freeze-thaw Stability
It is common for products to be subjected to extreme temperature conditions such as freezing or overheating during transport. Therefore, for some biologic products, it is necessary to be able to withstand some degree of temperature change during transport. Freeze-thaw studies are designed to put products through a series of extreme temperature changes known as freeze-thaw cycles. If no significant changes are observed after three cycles, our scientists confirm that the product is sufficiently stable for transport
- Photostability Studies
For the application of ligh, we simulate light and follow ICH guidelines for conducting light stability studies to assess the photosensitivity of biological drugs
Figure 3. Freeze-thaw stability studies for plasma and serum samples. (Stevens, V. L.; Hoover, E. et al. 2019)
Why choose BOC Sciences?
Our dedicated CMC team has provided tailored solutions to our clients from engagement to launch. With many years of industry experience, we provide clients with the following:
- Comprehensive, integrated CMC services with a flexible service model that grows with your programs
- Knowledgeable industry experts who deliver scalable, actionable insights
- World-class facilities and equipment that remain at the forefront of the global pharmaceutical research, analytical and development standards
- Our comprehensive services support products at every stage of the product lifecycle, from early-stage discovery to full commercial cGMP manufacture
- A focus on risk management that is designed to ensure completion of your technical goals
BOC Sciences provides professional, rapid and high-quality services of stability testing at competitive prices for global customers. Personalized and customized services of stability testing can satisfy any innovative scientific study demands. Our clients have direct access to our staff and prompt feedback to their inquiries. If you are interested in our services, please contact us immediately!
References
- Ammann, C. Stability Studies Needed to Define the Handling and Transport Conditions of Sensitive Pharmaceutical or Biotechnological Products. Aaps Pharmscitech. 2011. 12(4): 1264-1275.
- Stevens, V. L.; Hoover, E. et al. Pre-Analytical Factors that Affect Metabolite Stability in Human Urine, Plasma, and Serum: A Review. Metabolites. 2019. 9(8): 156.
