The Phyla System has been designed with our customers in mind using minimal ingredients and keeping all of the bad stuff out! Did you know that there are over 1500 banned cosmetic ingredients in Europe but only 10 in the USA? We designed and manufactured our product with rigorous quality standards to make sure the product was safe, non-toxic, and beneficial and all of our ingredients are neither banned in the US or in Europe. Our products are 100% animal component-free which means we are 100% vegan. We also do not test any of our products on animals and never will. We are Leaping Bunny Certified as 100% cruelty-free. Our products have been tested and are free of phthalates, parabens, and artificial fragrances. We are also nut-free, gluten-free, and use non-GMO plant-based ingredients.
When designing the Phyla System, we took great care to make sure that every ingredient was safe. We wanted to share some information about the probiotic ingredient in the serum and the quality by design principles that we established in the manufacturing process and testing process. As we have shared in other blogs, the probiotic we use is a C. acnes bacteriophage is found naturally on healthy skin. This probiotic targets the bad bacteria that are responsible for acne allowing the rest of the bacterial community on the skin to flourish. We want to be clear that this is not a medical treatment or phage therapy but a first-in-class cosmetic probiotic for the skin. Take a look at our Blog on “What is a probiotic” for more information.
Now, when we designed the manufacturing process for our probiotic we decided to keep this process in-house at our GMP manufacturing facility in Sonoma County CA to maintain control of the manufacturing process dotting all the i’s and crossing all the t’s. Our facility is 100% animal component-free and we follow all of the cosmetic products regulations and guidelines, but more importantly, we actually take this to the next level and follow many pharmaceutical guidelines as well which is not required. The proprietary probiotic ingredient is manufactured in small batches under cGMP quality systems (these are called current good manufacturing practices and you might read about these on labels of high-quality supplements you purchase). The manufacturing process that we use involves fermentation like other probiotic products but we use all vegetable-based components in this fermentation process which is actually quite hard to do! The final purification of the probiotic makes sure that the final product in the bottle is the bacteriophage in a stabilizing buffer and nothing else – we test the potency of the product in-house too to ensure that the phage is doing what it is supposed to do! We then further send out samples of this ingredient to a qualified independent third-party laboratory to test the product for safety and purity. We do this for every batch that we make. Once we have all of the testing complete, an independent Quality Manager reviews all of the manufacturing and testing records and if everything looks ok, signs off that this is released to be incorporated into the serum, then we transport this to our manufacturer who makes the final serum and bottles the product.
Now another thing that folks might wonder about is the stability of our probiotic serum. How stable is your probiotic? Is it still ok when you ship it to me? We have undergone rigorous stability testing to ensure that the probiotic in the serum is stable for a very long time refrigerated, at room temperature for about 2 months, and then even heated up in an incubator which is as warm as the body temperature for 2 full days! We have continuous ongoing cGMP stability testing and if any product fails to meet a specification, it will not be sold to our customers. We also have done mock shipping studies where we have shipped the serum across the country and subjected the serum to many temperature fluctuations and environments over a 2 week period. Once the serum was returned back to our facility, we tested it and the serum is completely stable with the probiotic remaining exactly the same as the way we manufactured it. Good news right? We do recommend that you refrigerate the serum once you receive it to ensure the integrity of the product as we do notice that the potency does start to decline a bit after several weeks at room temperature. The serum also is very soothing when applied chilled, so that’s an added bonus. We are working on a room temperature stable formulation as well for the future so stay tuned!
Here’s another question we get – is the probiotic safe? We have tested the probiotics on hundreds of volunteers and we have had no reports of any adverse effects whatsoever. The product is also currently in an ongoing cosmetic clinical trial with results coming out soon!
We are very excited to have our product now available for consumers and stand behind the quality systems, manufacturing, and testing that we have done to ensure that the product is of the highest standards and is safe! Thanks for reading and if you have any further questions send us a note at firstname.lastname@example.org.