How to Select the Right Private Label Probiotic Manufacturer

This is part of our Ultimate Guide to Private Label Probiotics, a complete overview of the benefits of probiotic supplementation for consumers, some of the different strains and their specific uses, the process of responsibly manufacturing a probiotic product, and what to look for when choosing a probiotic manufacturer.

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The dietary supplement category is both crowded and competitive, and it can be very confusing for consumers to recognize the quality of your brand. This is especially true for probiotic supplements due to the many challenges involved in manufacturing with these live organisms, and the different methods of labeling their active culture counts.

Consumers have become increasingly aware of the wellness benefits probiotics are studied for beyond gut health, and they are looking for more product options around potency, strains, gender, age, and other specific wellness goals. They want advanced blends, targeted formulas, and shelf-stable products that don’t require refrigeration. They also want transparency and traceability, so they can be confident that the product they are choosing delivers the benefits it promises on the label. For a brand, meeting those expectations starts with the choice of manufacturing partner.

The following are the most important criteria to look for when selecting a probiotic contract manufacturer or private label partner for your supplement.

Are CFUs Counted Through Expiration?

A commonly utilized deciding factor in selecting a probiotic product is the number of CFUs (Colony-Forming Units) it contains. CFUs are the groups of live microorganisms delivered in each serving of the probiotic. There are many challenges in keeping these delicate cultures alive until they are eventually consumed. The transportation or storage of probiotics in an unsuitable climate, for example, can easily kill them. Therefore, learning how many CFUs were present “at the time of manufacture” is not a reliable measure of what is still viable at the time of consumption.

ConsumerLab.com’s latest probiotic review tested 30 probiotic supplements, including three made for pets, and found that four could not be approved, mainly because they contained fewer viable probiotic cells than their labels led buyers to expect. The review also notes that some products footnote their listed amounts as of the time of manufacture, which does not promise that amount when the product is purchased.

Look for labels that state the CFU count “through expiration” to ensure this amount is provided in every dose until the product meets its expiration date.

Are the Right Strains in the Blend?

Are Targeted Formulas Using Carefully Selected Strains?

A probiotic product offering advanced blends may use several different probiotic strains in order to focus on one specific wellness benefit.^† The manufacturer will be careful to select strains that are hardy and that have supportive research to provide the desired benefits and will ensure that their finished formulation will protect them as they make their way into the gut.

Targeting Specific Wellness Needs

Probiotic supplements can be formulated to support specific wellness goals by including specially selected bacterial strains.^† For example, although Lactobacillus and Bifidobacterium are the most commonly used strains, there are several other strains that can provide more diverse and specific health benefits.^† For example, Lactobacillus helveticus and Bifidobacterium longum strains have been studied for their role in supporting a healthy mood and stress response.^† There’s even a relatively new name for probiotics that function in this way: “Psychobiotics”. These are a specific group of probiotics studied for their influence on the central nervous system and behaviors mediated by the “gut-brain-axis”.^†

Selecting these strains can create a potent formulation built around a specific wellness goal.^† Past and ongoing clinical research helps identify which probiotic strains offer the greatest benefits, whether for overall wellness or for a targeted area of support.

Providing More Probiotic Diversity

In addition to strains chosen for a specific goal, supplements can also be formulated around multiple strains in order to deliver more overall wellness benefits.^† Based on a number of studies, multi-strain probiotics have been studied for their beneficial effects on overall health.^†

Multi-strain probiotics can be formulated to support several areas of wellness at once.^† Combining several different strains is a common approach for products focused on digestive support, gut wellness, immune support, regularity, occasional gas & bloating, gut microbiota balance, and healthy mood support.^† The option to take just one product for such a broad range of support is both convenient and affordable.

Are Advanced Blends Including Added Active Nutrients?

A probiotic product offering targeted formulas may include additional active ingredients that have been studied for a specific wellness goal.^† Just as the probiotic strains mentioned above have been studied for their role in mood support, there are specific herbs and other nutrients that may offer this kind of support.^† For example, theanine has been studied for its role in supporting healthy levels of GABA, serotonin, and dopamine in the brain.^† These chemicals are known as neurotransmitters, and they play a role in regulating emotions, mood, concentration and more. Supporting healthy levels of these calming brain chemicals has been associated with relaxation and a better response to everyday stress.^†

Advanced blends and targeted formulas can be a strong fit for consumers with specific wellness goals, and consumer demand for these products is high. Private label probiotic offerings should include products that incorporate well-researched strains and other added nutrients, optimized for potency and stability.

Are Prebiotics Included?

Prebiotics are the healthy food that probiotics need in order to survive and thrive. Foods in the diet that are high in fiber provide various health benefits, and part of that fiber is prebiotic. The prebiotic part of this fiber passes through the upper digestive tract undigested and is fermented in the large intestine by the bacteria that live there. In addition to providing a food source for probiotics, prebiotics help support the growth of beneficial bacteria and help limit the growth of less desirable ones, which supports a balanced environment for digestive health.^†

Types of Prebiotics

For the most part, the prebiotics used in probiotic supplements are either oligosaccharides or inulin.

Fructo-Oligosaccharides (FOS) and Galacto-Oligosaccharides (GOS) are resistant to the human digestive enzymes that work on all other carbohydrates, so they are able to pass through the upper GI system without being digested. They then get fermented in the lower colon and produce short-chain fatty acids that feed the beneficial bacteria that live there. Both of these oligosaccharides have been shown to help support the immune system and help limit potentially harmful bacteria.^†

Inulin is a type of soluble fiber that is found in many plants and is also added into many dietary supplements as a food source for probiotics. Inulin has also been shown to help support the immune system and can help slow digestion, which can support nutrient absorption from food and help moderate the blood sugar response to carbohydrates.^†

The best probiotic formulations will include at least one type of prebiotic, as it is important to provide a food source for the probiotics to consume once they have made their way into the gut.

➤ Download our helpful checklist with the most important things to research as you compare private label or contract manufacturers for probiotics.

Were Raw Materials Stored and Transported Properly?

Because they are living organisms, probiotics have unique handling needs at every stage of the manufacturing process. Environmental conditions, particularly heat, humidity, and oxygen are key considerations for an experienced manufacturer looking to create a viable probiotic supplement.

The probiotic raw materials must be shipped and delivered to the manufacturer under appropriate temperature and humidity conditions. This will generally require the use of dry ice or a refrigerated truck. Upon arrival, the material will need to be refrigerated (or frozen) immediately and placed “on hold” for a quality assurance check.

Once the manufacturer has confirmed that the organisms have survived their trip to the facility, it is important to handle them carefully. Proper temperature and humidity levels need to be maintained throughout all stages of production. All steps in the manufacturing process should be carefully scheduled when working with probiotics, taking into account each point at which the probiotics may be left out or encounter any temperature fluctuations.

An experienced private label probiotic manufacturer will have precise knowledge of each of these steps and will have equipment specifically for controlling temperature and humidity throughout the process.

Was Formulation and Manufacturing Handled with Care?

Manufacturing with probiotics can be challenging due to the delicacy of the live organisms. A facility holding Good Manufacturing Practices (GMP) certification from a third party attests that it has stringent processes, procedures, and documentation in place. That certification also validates that products have the identity, composition, potency, and purity declared on the product label. At the formulation stage, R&D selects the ingredients that will deliver the desired wellness benefit and sets an effective starting dose (measured in CFUs) so the product remains viable through its expiration date. Depending on the finished product format, the team applies protocols that guard against anything that could compromise the stability of the finished product.

Probiotic raw materials carry high microbial counts, which can put the surrounding air, rooms, surfaces, equipment, and neighboring products at risk of contamination. For that reason, a manufacturer must apply moisture control, cleaning, and sanitation protocols whenever these materials are being processed. Climate-controlled conditions also need to be maintained at all times to protect the vitality of the organisms.

Is Quality Control and Testing Heavily Involved Throughout?

It is of utmost importance that Quality Control is involved at critical stages of the probiotic manufacturing process. This begins when samples are taken as the product is received and continues through blending, encapsulation, bottling, and shipping. These measures are necessary throughout production to ensure the stability of the product, and to ensure no cross-contamination has occurred.

There are three main types of testing your probiotic manufacturer should employ:

• Real-time stability testing keeps a sample of the finished product under its recommended storage conditions and checks it at set intervals, such as monthly or yearly. Products change as they age, and those containing live organisms are especially affected. The resulting data gives an accurate picture of how viable the product remains between the day it was made and its expiration date.
• Accelerated stability testing is a modified approach for estimating a product’s life span quickly when real-time data does not yet exist, as with a new product. The finished product is exposed to heightened stress, such as controlled shifts in temperature or humidity, to simulate the conditions it might encounter over a given period.
• Third-party testing brings in an impartial expert to verify the contents and identity of the finished probiotic, confirm that it was made under consistent, compliant conditions, and, in some cases, check that the label is accurate and meets regulatory standards.

After the internal and third-party testing and data collection are finished, the manufacturer releases the finished product for sale by its private label customers.

Is the Finished Product Shelf-Stable?

Many probiotics are now being manufactured as shelf-stable, which means that they do not have to be refrigerated to remain viable. This is much more convenient for retailers and consumers. Shelf-stable probiotics require specific manufacturing and quality control steps in addition to those required for probiotics requiring refrigeration. Shelf life is the number of days a product stays stable when stored under appropriate conditions.

Finished product stability testing is what determines a product’s projected lifetime and expiration date. Some manufacturers run only accelerated stability testing, typically to bring a new product to market as quickly as possible. That is frequently why a CFU count is labeled “at time of manufacture” instead of “through expiration date.” A label like that tells the customer little about how many cells are still viable a month after production, or six months later when the product is sitting at home. Real-time stability testing has the advantage here, because it gives a much more accurate measure of the finished product’s stability.

There are many ways the probiotic manufacturer can achieve this stability. Some use patented probiotic strains that have been manufactured using specially designed processes to preserve and ensure the stability of the organisms, without the need for refrigeration. There are also special capsules that can be used to protect the probiotics in their dormancy.

Summary

At the end of the day, you want to select a probiotic manufacturing partner who can offer you turnkey supplement manufacturing solutions, technical support, and training to help you successfully bring your products to market. Your manufacturer should have the experience and expertise to create viable, beneficial probiotic products that deliver what they claim to on the label. They should also be able to educate you about exactly what your product does, to support you in product development and sales.

Your customers demand transparency and accountability in their health supplement products. A private label probiotic manufacturer should be committed to helping you achieve a formulation that fits the exact performance benefits your customers are seeking.

Frequently Asked Questions About Choosing a Probiotic Contract Manufacturer

^†These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.