cGMP Contract Manufacturing FAQ

What Is Contract Manufacturing?

Contract manufacturing is a form of outsourcing. It is an agreement between a manufacturer and company to make products, or product components, on an agreeable, predetermined timeline. 

After the contract manufacturer completes their manufacturing portion, the outsourcing company will use the product in their own manufacturing. If the contract manufacturer is wholly producing the product for the outsourcing company, they will return the completed product. 

Contract manufacturing is a form of outsourcing. 

What is Third-Party cGMP Certification? 

Current Good Manufacturing Practice (cGMP) certification, ensures product control within a company with subsequent quality standards. cGMP Certification ensures product legitimacy and quality.

Is cGMP Certification Important?

When dealing with nutraceuticals, cGMP certification is crucial. Third-Party cGMP certification ensures the quality and efficacy of supplements. It prevents contaminated and adulterated supplements from entering the market, promoting user safety. 

Is Mineralife Third-Party cGMP Certified? 

Yes! Mineralife Nutraceuticals LLC is Third-Party cGMP certified. Mineralife offers cGMP manufacturing, custom supplement manufacturing, white label nutritional supplements, and custom CBD formulation services. 

What Is Private Label Supplement Manufacturing? 

Private label manufacturing allows entrepreneurial individuals and/or companies to partner with manufacturers to create their own supplement lines. Private label manufacturers offer product expertise as well as manufacturing capabilities. This allows outsourcing companies to create their own nutraceuticals. 

Partnering with a private label manufacturer allows entrepreneurial companies to brand already developed products. It omits the need to create new nutraceuticals from scratch.

Companies partner with nutraceutical companies to create their own brand line.    

Where Should I Reach Out If I Am Interested in Private Labeling?

If you have nutraceutical ventures you would like to pursue—custom manufacturing, CBD, white-labeling, co-packaging services—we would love to help!

Mineralife offers all of the above services. We love to set up frequent calls with our clients to check in on progress, provide real-time updates to their project and discuss forecasting. Transparency is important to us, and we know it is important to our customers as well. 

Liposomal Vitamin C: Is It Better Than Standard Vitamin C?

We discussed previously what liposomal delivery systems are. They have holistic benefits that add to your supplement experience. Liposomal delivery allows the supplement nutrients to take greater effect. Their bioavailability increases in the intended absorption areas.

What is Vitamin C? 

Vitamin C, also known as ascorbic acid, is a water-soluble nutrient that offers broad-based value in the body. It is necessary for the following body processes to occur:

  • Cartilage, Blood Vessel & Collagen Formation
  • Store & Absorb Iron
  • Protects Cells from Free Radicals
  • Aids the Natural Healing Processes
  • Antioxidant Function

Vitamin C is not naturally produced by the body, so it is important to intentionally consume it to ensure health in the above processes. Vitamin C can be found in foods—citrus fruits, berries, tomatoes, potatoes—making deficiency unlikely in a rounded diet. Certain conditions and lifestyles do promote deficiency, in which case supplementation may be beneficial. The daily recommended intake is 75 milligrams for adult women and 90 milligrams for adult men. 

Benefits of Liposomal Vitamins

Vitamin C is absorbed in the small intestine via proteins. What is not absorbed is then excreted because it is a water-soluble nutrient. When supplementing with standard Vitamin C tablets, ineffective over-supplementation tends to occur. This means you are excreting the bulk nutritional value of the supplement, unlikely to experience the benefit. 

*Look out for brands marketing high dose Vitamin C. Higher dosage does not equate to higher efficacy* Remember, you are not what you take. You are what you absorb

Liposomal Vitamin C helps to absolve the absorption issue! Liposomal Vitamin C holds the vitamin in a fat-soluble casing that prevents early release and promotes cellular absorption. It also prevents acid degradation when passing from the stomach to the small intestine. This ensures greater bioavailability at the absorption site. Liposomal Vitamin C ensures you experience optimal absorption and Vitamin C sufficiency.

Why Should You Choose Liposomal Vitamin C?

Above, we outline the benefits of switching your standard Vitamin C tablets for Liposomal Vitamin C supplements, but you may still be asking yourself why YOU should be making the change. See an expanded list of Liposomal Vitamin C Benefits below:

  • Increased Absorption: liposomes prevent breakdown and increase bioavailability
  • Save Money: a smaller dosage offers the same effect due to increased absorption
  • Fewer Side Effects: successful absorption prevents excess secretions
  • Enhances Existing Effects: positive effects of Vitamin C are enhanced

Liposomal Vitamin C assists in effective, holistic nutrient absorption. Supplementation should aid in positive health experiences. Liposomal delivery systems help in doing so.

Contract Manufacturing: What is it?

Supplement manufacturing in-house, though desirable, may not be feasible. Materials and time are finite resources, and manufacturing expertise is costly. The former should not prevent your supplement production goals. Consider adjusting your mode of production to contract manufacturing. 

Presumably, you have stumbled across this post with the intent of learning more about supplement manufacturing. What it is and what benefits it brings. Content below provides definition and offers benefits of the practice. 

Defining Contract Manufacturing

It is a form of outsourcing. An agreement between a manufacturer and company. The manufacturer will make products, or product components, on an agreeable, predetermined timeline. 

After the contract manufacturer completes their manufacturing portion, the outsourcing company will use the product in their own manufacturing. If the contract manufacturer is wholly producing the product for the outsourcing company, they will then return the completed product. 

 Contract manufacturing is a form of outsourcing. 

The following list details elements the may be outsourced in the nutraceutical industry:

  • Research: perform keyword and brand research
  • Sourcing: source and obtain high quality ingredients
  • Development: utilize experiential knowledge of product development 
  • Manufacturing: wholly outsource supplement manufacturing
  • Quality Control: experiential quality control, certification, and compliance

Benefits of Contract Manufacturing

Contract manufacturing offers a solution to the finite nature of manufacturing and production. Though not exhaustive, below you will find three key benefits of contract manufacturing. 

(1) Secure Market Entry

Establishing a reliable reputation is essential when entering the market. Small businesses struggle to maintain consistent production. Contract manufacturing resolves this. 

Allows companies to produce consistent, quality products. 

Increase your likelihood of producing consistent, high-quality products. Reliability gains recognition and promotes retention in the market. 

(2)  Increased Field Knowledge

supplement manufacturing in nutraceutical industry, contract manufacturing

It will provide outsourcing companies with substantive knowledge—expert advice. Outsourcing to experienced professionals allows you to create a successful product through those well-versed in the market. 

Access expert knowledge while retaining product ownership. 

Take supplement manufacturing for example—manufacturers offer expert advice in the formulation-to-labeling process. The outsourcing supplement company benefits from manufacturer knowledge, while retaining ownership and control of their product. 

(3) Lowered Costs

Finite costs tend to push companies towards outsourcing. Omitting factory costs—purchasing, maintaining, repairing equipment—creates surplus funds for companies to use elsewhere.

Outsourcing decreases machinery and staffing expenses. 

Outsourcing manufacturing decreases costs further by eliminating the need for factory staff. Contract manufacturers have established staffing. The cost does not fall on the outsourcing company.  

Quick Facts:

Contract manufacturing is a form of third-party outsourcing.

Benefits include the following: 

  • Secure Market Entry: allow companies to produce consistent, quality product
  • Increased Field Knowledge: access to expert knowledge while retaining ownership
  • Lowered Costs: outsourcing decreases machinery and staffing expenses

Liposomal Melatonin: Is It Better?

Daylight savings falls upon us again, and with it, adjusted sleep schedules. Some people adjust to the change immediately, but for many the time change takes a toll. Our body sleeps in a cyclical manner, correlative to our biological clocks. Just as our clocks sprang forward one hour, so must our biological clocks. Our key sleep hormone—Melatonin—is released in conjunction with our biological clocks, so supplementation has the potential to speed the sleep-adjustment period. 

What Is Melatonin?

Melatonin is a hormone produced by the pineal gland in your brain, then released into the bloodstream. Melatonin production is prompted by darkness and stopped with light. Its production is regulated by your circadian rhythm—our biological 24–hour clocks—supporting your sleep cycle. Melatonin is integral in the sleep-wake cycle, working with our circadian rhythm to facilitate habitual, quality rest. 

Is Supplementing Melatonin Beneficial?

Melatonin is naturally occurring, but individuals may interfere with production through light exposure. Regardless of light source—overhead to devices—the light triggers our pineal gland to stop producing melatonin, thus inhibiting the sleep cycle. Remedying this cause of insomnia is simple: remove the light source. Insomnia and sleep disturbances can also develop for reasons outside of your control. In such cases, supplemental melatonin may aid in readjusting your circadian rhythm. Studies show supplementing Melatonin may be beneficial in the following causes of sleep hinderance: 

  • Delayed Sleep Phase: reduces time spent falling asleep
  • Insomnia: benefits if the cause is melatonin deficiency
  • Blind Circadian Rhythms: improve sleep disorder symptoms in children and adults
  • Jet Lag: improve daytime sleepiness, increasing alertness

Studies are not wholly conclusive, but melatonin supplementation is suggested to be potentially beneficial in the above sleep afflictions. Melatonin is typically recommended for short-term use, working as an aid in rewiring natural sleep cycles via your circadian rhythm. Recommended starting doses range from 0.5 milligrams to 1 milligram. 

Should You Take Liposomal Melatonin?

Liposomal Melatonin functions on the same basis as all standard liposomal delivery systems. The hormone is encapsulated in a lipid bilayer that withstands travel to the desired biological site. It is delivered to the cellular site with greater bioavailability than standard Melatonin tablets. Metabolization of the hormone is not required with liposomal delivery, increasing the efficacy of hormone absorption. 

Now, we beg the big question: is liposomal Melatonin superior to standard tablets? The answer is…maybe! Liposomal Melatonin does offer a greater bioavailability for absorption, but physiological needs differ from one individual to the next. 

As always, consult with your healthcare provider if you have explicit needs and/or concerns!

Liposomal Delivery in Nutraceuticals

Nutraceutical prevalence and research grows exponentially each year. With that growth comes brand competitiveness. The market is encouraging nutraceutical brands to refine the quality of delivery mechanisms. Consumers are demanding effective products. Research responsively created liposomal delivery systems that elevate nutraceutical absorption and effect. 

Liposomes: Advanced Nutraceutical Delivery System

The quality of nutrients you supplement is vital—we know that. What many don’t realize is that delivery mechanisms hold an equally important role. If a supplement releases the nutrients at inopportune times, you will not experience your desired effects. Liposomal delivery is biologically intelligent. It was created to deliver nutrients in the desired, optimal location. 

Liposomes function as nutraceutical delivery drivers, delivering nutrients to our body cells.  Liposomes are created with hydrophilic (water soluble) heads and hydrophobic (water avoidant) tails, making them fat-soluble. This dual nature allows manufacturers to encapsulate desired nutrients in each supplement with targeted delivery upon consumption. The fat-soluble composition allows nutrients to be delivered to the correct cells. This allows optimal absorption takes place. The nutrients transported in liposomes range from vitamins to minerals to coenzymes. 

Why Choose Liposomal Delivery?

Liposomal delivery increases absorption through bioavailability. Less efficient means of absorption are bypassed. The substance reaches intended cellular destinations. Regardless of nutrient quality and dosage, you will not receive desired benefits if you are not adequately absorbing the nutrient in the intended cellular area.

After all, you are not what you take. You are what you absorb

Advantages of Liposomal Delivery

  • Bioavailability: higher absorption than other oral supplements
  • Increased Delivery: increased intracellular delivery
  • Inclusive: ideal for those who cannot swallow tablets
  • Adjustable: allows for incremental dosing for all ages
  • Cost Effective: lower dosages offer the same effect

Mineralife Named Top 10 in Contract Manufacturing

Communication, customer service and the ability to be completely transparent with our customers. These are only some of the reasons Mineralife Nutraceuticals was named a Top 10 Contract Manufacturer by Manufacturing Outlook.

Founder and Owner, Neil Butterfield has been a leader in the dietary supplement industry for more than 10 years. He does not plan on slowing down anytime soon. Mineralife has specialized in liquid supplements and powder capsule formulations for quite some time. The goal is always ultimate bioavailability.

After all, you are not what you take. You are what you absorb.

What’s Next for Mineralife Contract Manufacturing?

In 2022, Mineralife Nutraceuticals will be launching a liposomal contract manufacturing option to their service line. Soft gel manufacturing will begin nearing the end of Q2. The sky is the limit for both Mineralife and our customers. We will be one of the very few manufacturers to offer customizable soft gel products at a low minimum order quantity.

Of course, we did not get this far by saying ‘yes’ to everything. The process of taking on new projects for clients is selective. Mineralife chooses to work with clients based on research and development projects, respect towards regulatory compliance, and a shared dedication to quality. Luckily, Mineralife Account Coordinators are there for clients every step of the way. They will guide our customers through each of these processes.

Offering a turnkey custom manufacturing solution, we pride ourselves on quality, honesty, and hard work. A large database of raw materials is at our fingertips and grows by the day. We can guide our customers towards an effective formulation, whether a powder capsule, liposomal product or a liquid supplement. Equipped with a great team of label regulatory experts, we can steer both Mineralife and our customers in the right direction.

What can we create for you?

We love to set up frequent calls with our clients to check in on progress, provide real-time updates to their project and discuss forecasting. Transparency is important to us, and we know it is important to our customers as well.

We closed 2021 by achieving a third-party cGMP certification and a third-party USDA Organic Handler certification. Entering 2022, we are dedicating the honor of being named a Top 10 Contract Manufacturer to our dedicated staff, long-term customers, and everyone else who has supported us along the way. We are excited for what this new year will bring.  

Nutraceuticals vs Pharmaceuticals

You may be asking yourself “What are nutraceuticals?”

In the simplest of terms, nutraceuticals are used to describe a product that can support an individual’s overall health, wellness, and longevity. 

These products are generally naturally derived.  Many originating in Eastern medicine with supported uses spanning millennia. Your daily multivitamin or magnesium supplement fall under the umbrella of a nutraceutical. Other examples include ashwagandha or lion’s mane capsules, liquid ionic zinc, liposomal vitamin C and more.

You will find these nutraceutical supplements available over the counter; this means you can just wander into your local grocer or health food store and purchase them like you would an apple or an orange. If you find yourself in this position you are hoping the product will support your health, wellness and longevity.

The nutraceuticals market is regulated by the FDA officially. Unofficially, much of the market is self-regulating. This can be scary, because it means you must trust that the product you are purchasing was manufactured in a clean environment with high quality standards for its ingredients, manufacturing and bottling process and more. Unfortunately, you will find a high variability in quality and reliability from custom manufacturers. So, if you are considering purchasing or creating your own nutraceutical supplement – be sure to do your homework on their current good manufacturing process.

So then, what are pharmaceuticals?

Earlier we mentioned apples and oranges. Nutraceuticals and Pharmaceuticals are like apples and oranges when it comes to source, purpose, manufacturing and more. Pharmaceuticals are synthetically derived and developed to acutely treat a specific symptom or underlying disease.

Pharmaceuticals are generally prescribed. Sometimes, they are sold as an over-the-counter drug such as aspirin. Pharmaceuticals can be considered intellectual property. This can encourage a monopolized market with only one purveyor of a certain drug. In these instances, price control and price gouging can occur for highly sought-after products.  This industry is much harder to enter as a new company.

Which one is right for me?

There is no one shoe fits all model here.  As a consumer, some of our ailments are treated with pharmaceuticals while others may be prevented with nutraceuticals. Research has shown positive results from a body kept in balance.  Talk with your trusted health professional today and see if nutraceuticals are right for you. If you are considering entering as a new brand, you will need to ask yourself the purpose of your product: Are you helping support health and wellness? Creating a nutraceutical may be right for you. Are you trying to treat and cure a disease? The pharmaceutical industry is the only one legally able to do this.