Live biotherapeutic products (LBPs) require to perform biological safety evaluations, including biocompatibility tests to ensure safety. Chemical characterization can help support the biocompatibility testing process, reduce the use of animal testing, in some cases, shrink turnaround time & cost, and, perhaps, eliminate the need to do some biocompatibility testing altogether. Creative Biolabs provides a full range of comprehensive and flexible chemical characterization tests to meet the needs of global customers.
Interest in the use of bacteria-containing products for the treatment or prevention of disease has increased in recent years. Bacterial preparations for human consumption are commercially available in the form of dietary supplements and typically contain strains with a history of use in food fermentation. Advances in our understanding of the role of the microbiota in health and disease lead to the development of products containing more novel bacterial species, along with genetic modification of strains to provide specific functions.
LBPs are not intended to reach the systemic circulation targeting distant organs, tissues, or receptors, but rather exert their effect through direct interactions with the complex native microbiota and/or the modulation of complex host-microbiota relation, indirectly leading to distant biological effects within the host. Hence, developers must rely on thorough risk analysis, and pharmaceutical guidelines for other biological products should be taken into account to design relevant non-clinical and clinical development programs.
Chemical characterization is the process of defining the chemical properties of one or more components of a substance or device material. Characterization can also be a valuable first step before performing a more intensive impurity identification study by eliminating some variables from the investigation.
As an undoubted leader in the probiotics field, we provide a wide range of chemical characterization tests to meet different demands in LBPs discovery and analyses, as follows:
Creative Biolabs provides customizable LBPs’ discovery services to address research challenges. With more than 10 years of experience, we provide flexible solutions to help you get milestone success. Our consultants excel at understanding the challenges you face and providing the information you need to make informed decisions. We are the expert you can trust when you are doing chemical characterization tests. If you have any scientific research requirements or questions, please feel free to contact us .
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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