Lyophilization Development Services

Live biotherapeutic products (LBPs) play important roles in promoting and maintaining human health. To be of practical use and convenience to consumers, probiotic bacteria must be formulated in a usable form often dehydrated through lyophilization (freeze-drying). As a leader in novel LBPs development, Creative Biolabs provides the most advanced facilities, capabilities, and expertise to accelerate the discovery, cGMP manufacturing, and clinical application of LBPs. Our standard lyophilization procedure has been widely applied to produce viable culture in dried powder form.

Lyophilization for LBPs

Because LBPs are live organisms (bacteria or yeast), the dose and the viability of probiotic strains are important criteria for probiotic efficacy during storage. The therapeutic efficiency strongly depends on the viability of probiotic microorganisms. Freeze-drying (lyophilization) has been the mainstay in the preservation of pharmaceutical and probiotic drugs. This method can maximumly retain the viability and functional properties of LBPs during the storage and passage through the stomach.

Lyophilization Capabilities at Creative Biolabs

Lyophilisation is a complex science, involving the dehydration by sublimation of frozen ice present within the molecules. Our specialist scientists are active in the field of lyophilization, with many years’ practical experience. We have substantial knowledge of the challenges of operating an efficient and robust freeze-drying process and the experience to troubleshoot your problems.

• First-class freeze dryers with flexible unit capability (up to 1500 kg), vacuum set-points, and variable shelf temperature options;
• An optimized freeze-drying procedure with best-fit temperature, water activity, and atmosphere (air, vacuum, and nitrogen);
• Various cryoprotectants resulted in almost no loss of viability during freeze-drying;
• Optimum storage conditions (frozen storage, replacement of oxygen with nitrogen, and water activities between 0.11 and 0.22);
• An appropriate combination (soy protein, maltodextrin, skim milk, and arabic gum) was selected as carrier and storage conditions;
• Continuous optimization of the program and recipes to ensure a greater product yield and efficacy;
• Real-time record/analyze data, as well as operate/remotely monitor the lyophilization cycle;
• Regularly updated in response to feedback from changes in cGMP and advances in processing technology;
• Customer-tailored material and lyophilization process compatible with the specific probiotic;
• Subsequent evaluation of the changes (stability and viability) in the probiotic efficacy during lyophilization.

Lyophilisation stabilizes the product, concentrates large quantities down to a very small volume, increases its potency, and produces sizable batches, as well as makes it very easy to transport and store. As a leader in LBPs discovery solutions, Creative Biolabs provides full lyophilization services spanning many organisms, industries, and production volumes. Our lyophilization can maximumly retain the viability and functional properties and is relatively low cost. If you are interested in our services, 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.