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 recognized 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 trade.

Lief Labs began off on the suitable foot instantly by getting NSF Licensed — NSF is an organization that strictly enforces prime 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 clever proper there in home, and may 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 position in formulation and bringing the product to life, however asks if it’s completely obligatory if somebody with system is available in wanting 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 joyful to have helped somebody within the trade.

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 desires 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 gotten a system in thoughts?”, “What does your buyer appear like?” and “What’s it that your buyer is on the lookout for?”

In case you can articulate who your prospects are, then Lief might help you construct a greater complement for them.

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

Getting Drug Examined? Follow NSF Licensed Dietary supplements

Ben goes on to ask Meg how the NSF certification performs a task 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 have to be as excessive as Lief’s to make sure that the client is getting the very best high quality substances. As soon as a system is nailed down, a quote can be put collectively, and from there changes could be made as obligatory.

12:00 – How the prices break down

Mike asks Meg how early value is introduced into the product improvement course of and all of the components that actually 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 value level, goal retail value, ingredient prices, packaging and labels, quantity of the order, and extra.

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

15:40 – Prop 65 Warning and Authorized Necessities

Mike asks about Prop 65 warnings and some 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 attempting 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 beneath 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 system, swapping out substances 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 convey 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 likewise 2500 items for capsule merchandise. There may be 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 consists of system, packaging elements, flavoring placeholder, manufacturing, and labor. From there the R&D course of is began and taste is mentioned.

In Ben’s instance position 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 substances which are contained in the product. Meg shares a shaggy dog story of her within the R&D lab solely 4 days into the job and having to style uncooked theacrine and chase it with a Woman Scout Cookie to do away with the dangerous style.

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

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

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

If going pure, Lief will faucet in with their consultants and companions to discover a answer to make your product style pretty much as good as doable – however it’s undoubtedly extra of a problem since stevia and different pure sweeteners aren’t 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 constituted of extracts and powders from pure substances, like a strawberry. Synthetic flavors are made synthetically and aren’t 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 strive a few totally different flavors. The samples are shipped out or you possibly can spend time within the lab your self. From there, Meg collects info on what might be tweaked to make the flavors style pretty much as good as doable. A few of the changes that may be made are including extra taste or sweetener, adjusting acid ranges, and even swapping the forms 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 bought a job at a fitness center and began noticing that the fitness center was promoting dietary supplements with substances inside that she was finding out at school, which piqued an curiosity. She tried her first pre-workout and bought the notorious beta-alanine tingles, and ended up writing her senior thesis on what it does to your physique.

By way of 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 can assist you acquire any certifications or carry out any testing that you just search, whether or not or not it’s testing ranges of sure substances or getting the product non-GMO verified. After that, the complement details panel must be laid out, whether or not it lists all of the substances and their precise quantities or it’s (sadly) a proprietary mix. The benefit of Lief is that even when there’s a prop mix, they nonetheless take a look at as regular and may make label claims, which you don’t see typically.

50:15 – Lastly, manufacturing!

Based mostly on the completed system with all of the substances, flavoring, and sweetening, Lief will select an applicable bottle dimension and lid. They don’t have a design staff in home to make labels, however have numerous nice connections that they’ll refer you to (see Episode #087 with Taylor Knox of NutraMedia for an excellent instance) and can verify 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 inserting 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 some other objects that can be wanted to get every thing executed as required.

58:00 – The manufacturing course of

Order is positioned. Now it’s time for the Lief staff to plan the logistics of getting this product made and into a bath. Based mostly on the substances picked for the system, 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 precise substances get to the ability, the ingredient distributors have to fill out a spec sheet provided by Lief as a primary step within the strategy of QA/QC. As soon as the substances are authorized to be used, the shoppers will get a pallet setup for them with all of the substances weighed out on it that may go into the product.

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

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

Lief Labs has merchandise getting BSCG licensed, wich is a testomony of their unimaginable prime quality

Finally, by legislation, the model is accountable if one thing goes flawed throughout manufacturing and the product nonetheless reaches the market. Nevertheless, the model will almost certainly be requested the place the product was produced, and an audit can be executed 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 should be made to make sure they’re producing secure merchandise for the general public.

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

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

Mike asks if widespread substances 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 wish to use caffeine that’s been sitting on the shelf for a very long time. Lief strategizes their ingredient orders based mostly on how typically they’re used and makes positive the substances shelf life will work for the product’s shelf life.

1:05:40 – Making certain the product comprises 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 clever. 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 additional of every (overage) inside to ensure there’s sufficient even after long-term degradation. Lief does put in a certain quantity of overage for every ingredient to depend for potential loss throughout the manufacturing course of. These overages are constructed into the price of the system so it’s not an added payment 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 work out 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 substances have been a line of natural rice excipients (floli), which might change capsule fillers like silica to offer a pure different. This was transfer on Lief’s half as a result of it additionally will get them concerned within the provide chain the place they’d be utilized extra in comparison with a particular model of a botanical extract that will solely be seen in an vitality 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 substances like oat milk powder (Oatzi, which is utilized in Soul Efficiency Diet 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 different to issues like gums which are usually put into protein powder. Some staff members have been juicing celery however didn’t benefit from the course of of truly doing it, in order that they developed their celery juice powder to offer a simple different.

1:18:39 – Lief Raws makes perform based mostly substances too

Lief seen a rise within the pattern of liposomal expertise in dietary supplements, however not essentially executed the suitable method and as an alternative was principally used for advertising and marketing. Lief needed to make use of this expertise 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 sort of Liposomal Caffeine for a sustained launch — Biozomal Caffeine. Learn the way Biozomal Know-how is not simply your common lipid encapsulation!

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

1:24:50 – How Lief brings substances in

Mike asks Meg how strict Lief is with regards to bringing substances 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 distributed to Lief’s facility, the seller must fill out correct paperwork to stick to Lief’s in place necessities. A few of the issues on these kinds might be kosher statements, nation of origin, and allergen statements. If there are any substances (like NMN) which are up within the air with the FDA, Lief shouldn’t be working with them till they’re totally cleared.

The trio indicators off and says thanks.