Microbial Stabilization Services
Live biotherapeutic products (LBPs) are defined as live organisms designed and developed to treat, cure, or prevent a disease or condition in humans. Notably, LBPs should exclude vaccines, filterable viruses, oncolytic viruses, and organisms used as vectors for transferring genes into the host to maintain their stabilization. Creative Biolabs is a pioneer and undisputed global leader in microbial stabilization services. We offer a full range of LBPs cGMP manufacturing services.
Stability Testing
LBPs are required to go through a stability profile to find an expiration date and verify the efficiency and safety after a long time. During this testing, the product will be submitted to a variety of temperatures and humidity conditions over a while. Additionally, the effect of UV light on the product, and a variety of other conditions will be also tested. Biological and physical stabilization by formulating and drying is necessary to produce manageable, easily applied, and storage-stable bioproducts. Even so, drying and storage will inevitably expose the microorganisms to environmental stress. Once further safety and stability tests are complete and the formulation is finalized, we will ensure that the product will maintain the intended performance and consistency when being transferred to a large batch formulator or manufacturer.
Our Microbial Stabilization Services
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Selection of test samples for stability tests.
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Characterization of a biotechnological or biological product (which includes the determination of physicochemical properties, biological activity, immunochemical properties, purity, and impurities).
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Design of stability tests for different types of strains.
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The stability plan determined in conjunction with customer requirements.
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Stability study: light, temperature, humidity, appearance, pH, water loss, long term stability studies according to International Conference on Harmonisation (ICH) Q1A guidelines.
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Repeated freeze/thaw stability.
Highlights of Microbial Stabilization Services
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Our comprehensive stability testing services include identity, purity, physicochemical, and potency assays.
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Our experts will design a tailored stability package that will meet your needs and the expectations of the regulatory authorities, as well as being in line with your critical product quality attributes.
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We offer this service either as part of a manufacturing project or as a stand-alone service.
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Our goal is to provide the optimal test mix and specialized services to successfully meet the requirements of your LBPs’ analysis trials in the most effective and cost-efficient manner possible.
In both the United States and Europe, the development of LBPs requires the demonstration of quality by establishing safety, reliability, robustness, and consistency of each batch produced. Creative Biolabs offers LBP microbial stabilization services to ensure their efficiency and safety. Please contact us for more scientific support.
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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