Stability tests for live biotherapeutic products are essential to assess sensitivity to a large range of factors that impact biologic activity, product safety, and quality. Creative Biolabs’ leaders have over ten years’ experience in live biotherapeutics stability testing. Truly quality-indicating stability tests will be developed at Creative Biolabs to secure that the live biotherapeutic products are highly viable and present a good capability.
Stability testing is a vital part of product development and is conducted throughout a product’s life cycle. Stability studies ensure that the live biotherapeutic products remain safe and effective for their intended use through-out their specified shelf life. Now, Creative Biolabs provides a host of complex analytical methodologies to determine the stability of live biotherapeutic products, and these are justified and validated. These stability test usually includes method development, method validation, and a stability study. Creative Biolabs can work with you to find the best solution to your stability tests for live biotherapeutic products.
When requested by clients, we develop specific stability tests. Our scientists are adept at conducting accelerated stability studies, short and long-term stability studies for live biotherapeutic products. Working with our experts who have stability-indicating analytical method development skills, we provide assurance that any changes in physicochemical properties could be detected, including but not limited to structure, aggregation, biological activity, visual appearance, impurities, excipient degradation, and container/closure interactions. Moreover, we provide stability data to demonstrate that your new products are within acceptable chemical and physical limits for the planned duration of the clinical investigation. Stability test services at Creative Biolabs drive your stability programs forward, which is coupled with project management and regulatory support. At the same time, if stability issues are observed, our development team with extensive experience uses stability data to provide the next level of support.
Stability study is a key step in new drugs and new formulation development. Creative Biolabs can provide formal and informal stability testing for live biotherapeutic products. Customers can choose different testing methods according to our test protocol and your project requirements to fully understand product stability.
Bringing quality and safety to life, Creative Biolabs offers fully quality assurance expertise to help you to meet quality, safety, and regulatory standards for your live biotherapeutic products. We have more experienced scientists who are dedicated to stability tests and developing new assay platforms and methodologies. Contact now to learn how we can help you continue to produce safe, high-quality live biotherapeutic products.
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