Lief Labs: Complement Manufacturing 101 with Meg Ligot

0:00 – Introduction

Mike, Ben, and Meg kick off the podcast with an introduction on Lief Labs, a dietary contract producer identified for its distinctive high quality. Lief’s been round since 2008, their CEO has a background in biochemistry, and his first job was within the business.

Lief Labs began off on the best foot instantly by getting NSF Licensed — NSF is an organization that strictly enforces top quality and requirements for producers. Meg says {that a} key distinction between Lief and different contract producers is that they do every thing product improvement sensible proper there in home, and might present full complement manufacturing providers from ideation to creation.

3:30 – How Lief Works With Their Prospects

Mike transitions from Meg’s assertion of Lief taking part in an enormous function in formulation and bringing the product to life, however asks if it’s completely vital if somebody with a great components is available in trying solely for manufacturing, particularly if the funds is tight. Meg counters this by stating that Lief doesn’t even cost for product improvement – an enormous bonus! Lief will work with any buyer with the hope that if they’re concerned within the formulation course of, they would be the producer for that product. If it doesn’t work out, they’re nonetheless completely happy to have helped somebody within the business.

6:00 – Instance of the method with Lief as a brand new model proprietor

Ben places himself within the sneakers of a brand new model proprietor who needs to supply a pre-workout complement, however has little to no data or expertise on how to take action. He asks Meg what his expertise can be like when asking Lief for contract manufacturing providers.

After reaching out to Lief, you’ll first undergo a few introductory questions resembling “What’s it that you just’re on the lookout for?”, “Do you’ve a components in thoughts?”, “What does your buyer seem like?” and “What’s it that your buyer is on the lookout for?”

In the event you can articulate who your clients are, then Lief can assist you construct a greater complement for them.

8:15 – NSF Certification and Persevering with the Formulation Course of

Getting Drug Examined? Keep on with NSF Licensed Dietary supplements

Ben goes on to ask Meg how the NSF certification performs a job within the scenario he simply performed out formulating a brand new pre-workout. This transitions into speaking about Lief’s ingredient distributors and the way their requirements should be as excessive as Lief’s to make sure that the client is getting the best high quality elements. As soon as a components is nailed down, a quote can be put collectively, and from there changes could be made as vital.

12:00 – How the prices break down

Mike asks Meg how early worth is introduced into the product improvement course of and all of the components that basically go into it. Meg talks about the way it’s concerned virtually the entire time as a result of there’s a lot that goes into: goal demographic and their worth level, goal retail worth, ingredient prices, packaging and labels, quantity of the order, and extra.

Ben asks if Lief will herald new elements that they don’t carry, and they’ll attempt to take action (if it adheres to their requirements and authorized compliance), however perceive that this performs into the price and lead time of the ultimate product.

15:40 – Prop 65 Warning and Authorized Necessities

Mike asks about Prop 65 warnings and every other authorized necessities that will come about and the way Lief helps these. Meg solutions by saying that if there are any particular testing measures or certifications that the client is making an attempt to get, it’s greatest to convey them up in dialog as early as doable because it begins with ingredient sourcing and dosages.

For instance, if a buyer wants to remain underneath 2 ppm (elements per million) for lead, they should see what every ingredient yields for lead and regulate accordingly. This might result in altering ingredient dosages within the components, swapping out elements for others, or discovering a brand new supply of an ingredient that’s yielding too excessive of lead. All of those components can have an effect on lead time and produce on different potential dangers to the product.

19:40 – Product minimums and what they’ll do

As of proper now, the product manufacturing minimums are 2500 items for powders (per taste) and in addition 2500 items for capsule merchandise. There’s some flexibility since not each buyer and scenario is identical, which is a pleasant function of Lief Labs. They’re a dry powder producer, that means they’ll do powders, capsules, and tablets – together with chewable tablets.

21:30 – Flavoring and sampling

Preliminary price contains components, packaging elements, flavoring placeholder, manufacturing, and labor. From there the R&D course of is began and taste is mentioned.

In Ben’s instance function he’s been taking part in for the podcast, he brings up that he likes mango taste however isn’t a cherry fan. Meg talks about what goes into flavoring and the way sure flavors could not work with the elements which can be contained in the product. Meg shares a joke of her within the R&D lab solely 4 days into the job and having to style uncooked theacrine and chase it with a Lady Scout Cookie to do away with the unhealthy style.

26:00 – Masking ingredient tastes that will not be nice

Ben and Mike ask Meg how they might take care of an ingredient that won’t style nice however the buyer actually needs to have it of their product.

She asks if the client would need to taste and sweeten naturally, or can there be synthetic elements like sucralose inside? Sucralose can masks flavors lots higher than pure sweeteners can, so selecting your demographic and elements properly early on is tremendous essential.

If going pure, Lief will faucet in with their consultants and companions to discover a resolution to make your product style nearly as good as doable – but it surely’s undoubtedly extra of a problem since stevia and different pure sweeteners will not be as candy as sucralose.

28:40 – Pure vs. synthetic flavors

Mike asks what the distinction between pure and synthetic flavors are, with Meg responding by saying pure flavors are produced from extracts and powders from pure elements, like a strawberry. Synthetic flavors are made synthetically and will not be essentially derived from nature or made utilizing pure extracts.

30:15 – Taste is picked, what’s subsequent?

After Ben chooses sucralose for a sweetener, it’s now time to get into the lab to attempt a few totally different flavors. The samples are shipped out or you may spend time within the lab your self. From there, Meg collects data on what could possibly be tweaked to make the flavors style nearly as good as doable. A number of the changes that may be made are including extra taste or sweetener, adjusting acid ranges, and even swapping the kinds of acids used, resembling citric and malic acids.

35:00 – Meg’s background

Meg’s background is in biochemistry, attending Mount Saint Mary’s in Los Angeles. She received a job at a fitness center and began noticing that the fitness center was promoting dietary supplements with elements inside that she was finding out in class, which piqued an curiosity. She tried her first pre-workout and received the notorious beta-alanine tingles, and ended up writing her senior thesis on what it does to your physique.

By connections within the fitness center, this led to her making use of for a job at Lief, and the remainder is historical past.

43:00 – Subsequent steps for product

Subsequent up is certifications and testing necessities that the client could also be searching for for his or her product. Lief works that will help you get hold of any certifications or carry out any testing that you just search, whether or not or not it’s testing ranges of sure elements or getting the product non-GMO verified. After that, the complement information panel must be laid out, whether or not it lists all of the elements and their precise quantities or it’s (sadly) a proprietary mix. The advantage of Lief is that even when there’s a prop mix, they nonetheless check as regular and might make label claims, which you don’t see usually.

50:15 – Lastly, manufacturing!

Based mostly on the completed components with all of the elements, flavoring, and sweetening, Lief will select an applicable bottle measurement and lid. They don’t have a design group in home to make labels, however have a number of nice connections that they’ll refer you to (see Episode #087 with Taylor Knox of NutraMedia for an excellent instance) and can examine over every thing in home as one other regulatory set of eyes.

When it comes to lead time for each capsules and powders, in our instance case 5000 items, it’s at present about 8-10 weeks till the product is manufactured, however don’t quote this as a result of it’s at all times altering.

There’s a ton of stuff that occurs between the client putting the order and it ending. The account supervisor can be in common contact with the model proprietor to get labels, handle certifications, and deal with every other gadgets that can be wanted to get every thing achieved as required.

58:00 – The manufacturing course of

Order is positioned. Now it’s time for the Lief group to plan the logistics of getting this product made and into a bathtub. Based mostly on the elements picked for the components, lead occasions can be calculated to make sure the client will get their completed product by the given time estimate (in our present case 8-10 weeks).

Contained in the manufacturing facility is the place the GMP requirements and tips actually kick into impact. Earlier than the particular elements get to the power, the ingredient distributors must fill out a spec sheet equipped by Lief as a primary step within the means of QA/QC. As soon as the elements are accepted to be used, the shoppers will get a pallet setup for them with all of the elements weighed out on it that may go into the product.

1:01:30 – What if one thing goes improper?

Mike brings up an excellent query after listening to Meg undergo the start steps of the manufacturing course of: what if one thing goes improper?

Lief Labs has merchandise getting BSCG licensed, wich is a testomony of their unbelievable top quality

Finally, by legislation, the model is accountable if one thing goes improper throughout manufacturing and the product nonetheless reaches the market. Nevertheless, the model will probably be requested the place the product was produced, and an audit can be achieved on the producer to see if they’re truly holding as much as the requirements and following tips appropriately. If not, they are going to be notified of corrections that must be made to make certain they’re producing protected merchandise for the general public.

Producers are extremely incentivized to keep away from issues resembling product remembers, authorized drama, and extra audits, so that is why Lief maintains cGMP (present Good Manufacturing Practices) so strictly.

1:03:30 – Are widespread elements at all times in inventory?

Mike asks if widespread elements like caffeine and citrulline are at all times in inventory on the Lief facility and the way they deal with their ingredient stock. Meg brings up an excellent level of the significance of shelf life in a product. In our instance pre-workout, she doesn’t need to use caffeine that’s been sitting on the shelf for a very long time. Lief strategizes their ingredient orders primarily based on how usually they’re used and makes positive the elements shelf life will work for the product’s shelf life.

1:05:40 – Making certain the product accommodates what it says it does

Ben asks what Lief does to make sure that they’re doing what they’re saying they’re doing manufacturing sensible. Meg responds by saying they do a performed-by, verified-by, and sign-off signature course of at a number of checkpoints all through the method. When mixing is full, Lief will take a serving of the product and ship it off for testing. Solely when all testing is full and passes the necessities that Lief enforces can they launch it to the client.

Ben then asks about dosing every ingredient and in the event that they put a bit further of every (overage) inside to ensure there’s sufficient even after long-term degradation. Lief does put in a specific amount of overage for every ingredient to depend for potential loss throughout the manufacturing course of. These overages are constructed into the price of the components so it’s not an added charge to the model proprietor which is a pleasant function.

1:11:15 – Testing is full, the product is able to be shipped!

As soon as the product has handed all of its testing necessities and is able to be shipped, Lief and the model proprietor will determine the logistics on what number of items and the place every thing goes, whether or not that be warehouses, success facilities, and even their house.

1:13:45 – Now we all know Lief Labs, however what’s Lief Raws?

Lief Raws took place after they began seeing the rise of client demand for pure merchandise. Their first elements have been a line of natural rice excipients (floli), which might exchange capsule fillers like silica to offer a pure various. This was a great transfer on Lief’s half as a result of it additionally will get them concerned within the provide chain the place they might be utilized extra in comparison with a particular model of a botanical extract that will solely be seen in an power complement.

Soul Efficiency is out with a brand new magnificence and wellness collagen product backed with Velositol, and it makes use of Oatzi to enhance taste and texture!

Lief additionally has different elements like oat milk powder (Oatzi, which is utilized in Soul Efficiency Vitamin Bliss Revitalize Collagen) and celery juice powder (CeleVida) that got here to be from concepts from folks inside their very own groups. Meg developed the oat milk powder as a pure various to issues like gums which can be usually put into protein powder. Some group members have been juicing celery however didn’t benefit from the course of of really doing it, so that they developed their celery juice powder to offer a simple various.

1:18:39 – Lief Raws makes perform primarily based elements too

Lief observed a rise within the pattern of liposomal know-how in dietary supplements, however not essentially achieved the best means and as an alternative was principally used for advertising. Lief wished to make use of this know-how appropriately and apply it to an ingredient that was very generally used, and this led to their liposomal caffeine (Biozomal Caffeine) coming to fruition.

1:21:00 – Pill manufacturing at Lief Labs

Lief Raws has a brand new kind of Liposomal Caffeine for a sustained launch — Biozomal Caffeine. Learn the way Biozomal Know-how is not simply your common lipid encapsulation!

Lief Labs provides a line of licensed natural tablets which can be pre-developed formulation that may be chosen by the client. In addition they supply a full line of gummies to allow them to present a number of choices to their clients with out them having to go to a different producer to get issues achieved. The gummies and tablets are all proven on the Lief Labs website.

1:24:50 – How Lief brings elements in

Mike asks Meg how strict Lief is with regards to bringing elements in for use for a product. She responds by saying they’re very strict and comply with the GRAS and NDI tips to make sure nothing is coming in that shouldn’t be. Earlier than any ingredient is shipped to Lief’s facility, the seller must fill out correct paperwork to stick to Lief’s in place necessities. A number of the issues on these kinds could possibly be kosher statements, nation of origin, and allergen statements. If there are any elements (like NMN) which can be up within the air with the FDA, Lief isn’t working with them till they’re absolutely cleared.

The trio indicators off and says thanks.