Stability Test for Live Biotherapeutic Products
Backgrounds Services Advantages Case Studies FAQs Resources
Background
Stability tests for live biotherapeutic products are essential to assess sensitivity to a large range of factors that impact biological activity, product safety, and quality. Creative Biolabs' leaders have over ten years of experience in live biotherapeutics stability testing. Truly quality-indicating stability tests will be developed at Creative Biolabs to ensure 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 live biotherapeutic products remain safe and effective for their intended use throughout 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.
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.
When requested by clients, we develop specific stability tests. Our scientists are adept at conducting accelerated stability studies, and short and long-term stability studies for live biotherapeutic products. Working with our experts who have stability-indicating analytical method development skills, we assure 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.
If you are ready to submit your samples for testing, please fill out the Sample Submission Form.
Advantages of Our Stability Test Service
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Customized analytical method and stability-indicating method
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Method development, method validation, and stability study
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Advanced stability-testing program (identity, potency, and purity)
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Reliable lab report
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Affordable price with the best quality
Case Studies
Frequently Asked Questions
What are stability tests for pharmaceutical products?
Stability studies should include testing of those attributes of the drug product that are susceptible to change during storage and are likely to influence quality, safety, and/or efficacy.
What is real-time stability testing?
Real-time (long-term) stability studies are experiments on the physical, chemical, biological, biopharmaceutical, and microbiological characteristics of a drug, during and beyond the expected shelf-life and storage periods of samples under the storage conditions expected in the intended market.
What are the 5 types of drug stability?
The type of stability is generally divided into chemical, physical, microbiological, therapeutic, and toxicological.
What is the difference between shelf life and stability?
Shelf life is defined as the time necessary for the drug to decay to 90% of its original concentration. product will remain stable when stored under recommended storage conditions. Thus, an expiration date is the date beyond which it is predicted that the product may no longer retain fitness for use.
The purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light, and to establish a re-test period for the drug substance or a shelf life for the drug.
Resources
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.
For Research Use Only. Not intended for use in food manufacturing or medical procedures (diagnostics or therapeutics). Do Not Use in Humans.
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