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.
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.
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.