The potential health benefits of live biotherapeutic products (LBPs) may not be realized because of the substantial reduction in their viability during storage and gastrointestinal transit. So, it is essential to enhance the resistance of probiotics to unfavorable conditions through appropriate packaging, fills, and lyophilization. With years of experience in LBPs discovery, Creative Biolabs is dedicated to delivering its customers high-quality manufacturing services that support novel probiotic products with solid scientific validation.
LBPs generally are probiotic bacteria that are live organisms designed and developed to treat, cure, or prevent multiple human indications. To produce enough health benefits, probiotic strains must be present and stored in a viable form to maximumly retain the viability and functional properties of LBPs. Appropriate packaging, fills, and lyophilization can help maintain LBPs’ high viability during the storage and throughout the gastrointestinal tract. Therefore, providing probiotic living cells with a physical barrier and dehydrated process to resist adverse environmental conditions is an approach currently receiving considerable interest.
We deeply understand that the viability and efficacy of LBP drugs are directly tied to both conscientious handling and meticulous packaging practices. With over several years of experience, Creative Biolabs is a leading company in the development and manufacture of LBPs according to strict quality standards, including LBPs’ lyophilization, packaging, and fills.
Lyophilization is the best preservation method to ensure bacteria stability. By sublimation under low pressure, the remaining water of LBPs can be eliminated. Lyophilization is a very delicate step for bacteria that are sensitive to extreme temperatures as it can affect their final viability. With many years’ practical experience, our scientists can operate an efficient and robust freeze-drying process and continuously optimize cryoprotectant formula and freeze-drying cycles to address each bacteria strain.
We provide exact probiotic packaging processes and a controlled production environment to circumvent the potential obstacles that can affect probiotics’ potency and viability. For anaerobic strains, exposure to air at any point in the manufacturing and packaging process will affect their viability; so our packaging process is closely controlled for issues such as humidity and oxygen to prevent degradation and death. We provide a variety of dosage formats to most appropriately dovetail with a product’s formulation, protection, and shelf-life needs, including but not limited to standard tablets, capsules, and powdered formats (stick-packs, sachets, and vials).
Filling or encapsulation is often mentioned as a way to protect probiotic bacteria against severe environmental factors. Our encapsulation services can create a micro-environment in which the bacteria will survive during processing and storage and released at appropriate sites (e.g. small intestine) in the digestive tract. Our filling capabilities include hard-shell capsule filling, sachet filling, liquid and cream filling, microencapsulation, etc. Amongst, the capsule materials include a variety of polymers, carbohydrates, fats, and waxes.
Our QC lab is responsible for maintaining quality systems within the facility so that product defects and mistakes can be kept to a minimum. In the meantime, they will actively test the strains at multiple points (in-process samples, intermediate samples, and end-product samples) during the manufacturing and packaging process to confirm the enough strength and activity of the probiotic. We are compliant with regulatory guidance and applicable standards to guarantee high quality.
Creative Biolabs has established an LBP manufacturing platform, offering its specialist formulation skills and wide-ranging manufacturing capability to the probiotics industry as a whole. We offer a one-stop-shop for probiotics lyophilization, capsule filling, and flexible packaging. Please contact us to learn how we can help you continue to produce 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.