Probiotic Production Explained
Probiotic production is a delicate process. It requires years of experience in microbiology and production, an investment in state-of-the-art equipment and a fine-tuned process to create a viable product.
The production process is not easy to master!
UAS Labs is one of the few probiotic suppliers invested in mastering the entire process, from Strain to Solution™.
We research, ferment, produce, package and even test our products in-house. With our wealth of experience and knowledge in the industry, we are excited to share with you the probiotic production process from start to finish – how a tiny bacterium becomes a powerful probiotic solution.
Step 1: RESEARCH AND DEVELOPMENT
Strain Selection & Isolation
The process begins with strain selection and isolation. This is the most crucial step for developing high quality probiotics. An individual strain is isolated, purified and validated for its probiotic capabilities, safety, and potential health benefits.
UAS Labs is proud to employ a team of probiotic professionals dedicated to the movement of probiotic clinical research by continuously sponsoring in-vitro and clinical studies around the world.
In concert with the science-centered probiotic strain selection, a bio-processing lab will study the strain to see what nutrients and other controllable parameters can be optimized for growth.
A probiotic manufacturer may conduct these studies in-house, like UAS Labs, or outsource this process to a contract manufacturer.
A strain will only enter large scale production once its unique recipe of nutrients and process parameters are established.
- NOTE: A strain’s unique recipe of nutrients is called “media”
Step 2: BACTERIAL PRODUCTION
The selected strain, along with its unique recipe of nutrients and process parameter guidelines will now enter large-scale fermentation, the first step of commercial-scale production. Fermentation is the process of growing and multiplying bacteria. To better understand this process, view our blog on probiotic fermentation.
To begin probiotic fermentation, the strain is added to the media in a large tank. The probiotic strain grows and multiplies in the warm and nutritious ingredient bath until the desired count of bacteria is reached.
- NOTE: All nutrients and equipment are sterilized prior to being provided to the bacteria. This eliminates any unwanted contaminants.
During this process, the tank of bacteria and nutrients accumulates the bacterial metabolites (the bi-product of the bacteria’s metabolism of the nutrients).
UAS Labs’ new cutting-edge facility located near Madison, Wisconsin is designed specifically for probiotic fermentation. Every detail of the plant is strategically designed to raise the standards for probiotic manufacturing in terms of quality, purity and safety. Learn more here.
The next step is to remove the metabolites.
A centrifuge is one way to separate the probiotic strains from the metabolites. You may have seen a smaller-scale centrifuge in your high school science lab. The machine rotates at high speeds creating centrifugal force. This centrifugal force separates materials of different densities, which is what forces the metabolites to separate from the bacteria.
Cryoprotection & Freezing
The remaining concentrate of probiotic bacteria must now be prepared for long-term storage. This preparation requires the probiotic strains to endure extremely low temperatures followed by a drying process to remove most of the water. Because of this, cryoprotectants are added to the probiotic cultures to help them survive the freezing and drying process.
At this stage, a few drying methods may be used.
A probiotic manufacturer may use the process of probiotic freeze-drying which is a gentler, but longer process, or spray-drying which is a shorter process characterized by higher temperatures and shorter times. It’s critical to optimize this step as it influences the probiotic strains’ viability and application suitability.
After passing through the freeze dryer and being properly processed, the probiotic has now been transformed into a dry powder and is ready to be used in a variety of applications! Reducing exposure to moisture once the product is dried is critical in maintaining probiotic viability.
It’s remarkable to think that manufacturing processes have been developed where you can take a living probiotic strain and process it in such a way as to remove most of the water, while still maintaining its viability!
Step 3: FINISHED PRODUCT MANUFACTURING
The bulk powder can now be sold as a single strain or in combination with other probiotic strains. For multi-strain formulas, other probiotic powders are now blended in. Equipment is used to evenly distribute the different ingredients into a balanced mixture.
UAS Labs offers this raw form of probiotics to other probiotic contract manufacturers for further processing. This probiotic form is commonly referred to as “probiotic raw materials”.
A probiotic formula can require the blending of several strains! See an example here.
Other essential ingredients that may be mixed with the dry probiotic blend may include:
- Ingredients that provide flavor for directly ingested formulations
- Ingredients that allow for the processing of alternate dosage forms (chewable tablets, stick packs, etc.)
- Ingredients that complement the probiotic’s health focus
- Properly chosen excipients to standardize the count of bacteria to the desired level
Once a probiotic formulation is complete, the blend is ready to be manipulated into its final dosage form. Dosage forms include: capsules, tablets, gummies or powder (for stick packs or application in functional food and beverages).
These dosage forms are then carefully packaged and prepared for shipment. While packaging and shipment may seem standard, these steps are incredibly important in maintaining probiotic viability. Probiotics must be packaged and handled in a way to avoid the following challenges:
- Light: Probiotic cultures do best when they are protected from direct light. Therefore, opaque or amber glass bottles should be used to block out harmful UV rays.
- Temperature: Probiotic cultures are also sensitive to temperature. Heat will drastically reduce their shelf life. Therefore, the temperature of the product is lowered as much as possible during storage and shipment.
- Moisture: Probiotic bacteria in dry powder form are hibernating. They are essentially dormant and we want to keep them that way until they are either consumed or added to a liquid product as they are activated by moisture. Desiccant packets or desiccant-lined bottles, such as our Stability Shield offering, are used to avoid the entry of moisture.
Once a probiotic solution is appropriately packaged, it is ready for shipment!
But there’s one more aspect we should mention…
A silent player in this whole process is quality assurance and quality control.
The quality team sets strict standards for the following areas:
- Sanitation of the probiotic facility
- Quality systems used to ensure the absence of probiotic contaminants
- Verification that product meets stringent specifications
Employees are involved by following uniform, hygiene and cleaning protocols to keep out contaminants. These quality procedures are continuously reviewed to maximize the efficacy of the final product and ensure the highest quality product is produced.
A probiotic facility must have the appropriate aseptic conditions in order to prevent the growth of non-probiotic bacteria. The quality team is instrumental in ensuring everything from the procedures to the equipment used are suitable for pure probiotic production.
Quality testing is conducted throughout the entire process, not just at the end!
The probiotic cultures are tested at various control points to ensure they meet rigorous probiotic testing standards. Testing identifies and tracks key indicators of successful probiotic production:
- Genetic Identification
- Enumeration – number of viable probiotic cultures present
- Absence of contaminants and pathogens
- Water activity
- Visual Inspection
By monitoring these indicators, a probiotic company can confirm that their probiotic is safe and effective for the end consumer.
UAS Labs is proactive in their approach to maximizing quality. Our company proudly uses an internal quality team but also utilizes qualified external parties for verification.
After quality testing is complete, the finished product is shipped to your local retailer and is ready for purchase and consumption. And that’s it! Our tiny, science-centered bacterium has now been transformed into a powerful probiotic solution on your local retailer’s shelf.
To learn more about UAS Labs’ facilities that make this entire process possible, visit our facilities page. To view our patented probiotics, DDS®-1, BNR17™ and Probiotic LRC™ backed by probiotic clinical research, visit our research page. To view our range of capabilities from Strain to Solution™, visit our offerings page.