As a new brand owner, if this is your first time having a dietary supplement manufactured, you may be curious about the specific steps involved in the process of manufacturing dietary supplements and the amount of time it takes to complete it correctly. Understanding these steps and the timeframes is crucial for setting realistic expectations as you navigate the development and production of your supplements.
This article will provide a start-to-finish overview of the supplement manufacturing process. It will also provide information on the time to manufacture supplements which, for a first-time order, will take 14-18 weeks from the date a purchase order (P.O.) is received. Thereafter, the process will take less time.
Understanding the Step-by-Step Process of Supplement Production
When addressing the question of how to make a supplement, it’s important to understand that the supplement production process involves several key steps. These include:
- Formulation
- Sourcing the Ingredients
- Testing the Ingredients
- Conducting Bench Work
- Manufacturing a Production Batch
- Testing the Production Batch
- Packaging and Labeling
- Shipping the Finished Product
The following provides details on each of the steps involved in how to manufacture supplements, along with the expected timeline.
Formulation
There are two types of formulation:
- Conceptual formulation
- Manufacturing formulation
Conceptual formulation involves choosing the right nutraceutical raw materials at the right doses to provide an evidence-based product that will have efficacy, and that will allow you to substantiate structure/function claims for the purpose intended. Typically, this is done by the brand owner, his or her staff, or consultants, although experts within a contract development and manufacturing organization (CDMO) may help.
Manufacturing formulation is a function of taking the existing conceptual formula, determining its viability from a manufacturing perspective, and adding any necessary excipients in the correct amounts to ensure the product will run correctly on a tablet press, an encapsulation machine, etc. Manufacturing formulation also involves expertise in sourcing appropriate nutraceutical raw materials that meet the specifications of the conceptual formulation. Although a well-formulated dietary supplement will not guarantee initial sales, it does make it much more likely that you’ll have good repeat sales once consumers have used it for the first time.
Timeline: The conceptual formulation of the product may take anywhere from a few days, weeks or months depending on the knowledge and experience of the person doing the formulating. The manufacturing formulation may take anywhere from a couple of days to a few weeks to adapt the formulation for manufacturing.
Sourcing the Ingredients
A well-formulated dietary supplement requires using evidence-based ingredients to help ensure product efficacy. Ingredients may be selected worldwide based on quality, and in forms that provide high potency and bioavailability. Without question, this is the step that takes the longest in the manufacturing process. Why? Here’s an example.
Let’s say the raw material in question is a probiotic. As live microorganisms, probiotic ingredients are typically made to order. They literally must be grown on a natural medium, and that doesn’t happen overnight. In fact, growing probiotics may take 6 weeks or so. Now, let’s say those probiotics come from Italy (which is often the case), so that means the finished material will be shipped internationally—which may take 1-2 weeks.
Of course, there are many raw materials other than probiotics—some of which have better stability and may even be stocked by the CDMO. Nevertheless, chances are that your chosen raw materials may not be stocked by the CDMO, or may not be stocked in sufficient quantity, so more will still have to be ordered. It may take 2-4 weeks for them to arrive.
Timeline: Depending upon the raw material, it may take 2-8 weeks for it to be delivered after it has been ordered by the CDMO.
Testing the Ingredients
Once the raw materials arrive at the CDMO, cGMP regulations require them to be quarantined and tested before they are released into inventory. The type of required testing includes identity and potency, microbiological compliance, and heavy metal compliance.
Identity and potency: To test for identity and potency, there must be an established methodology for testing the raw material ingredient. That methodology may exist in the U.S. Pharmacopeia, or be provided by some other credible source. Not only must that methodology be followed, but a standard must be purchased if the CDMO doesn’t already have the standard. If you didn’t already know, a standard is a validated sample of the raw material ingredient that the CDMO’s laboratory will use for comparison purposes. The raw material will be tested against the standard using appropriate laboratory equipment to see if it matches. Appropriate lab equipment may include Fourier Transform Infrared (FT-IR) Spectroscopy, Ultraviolet-visible (UV-VIS) Spectroscopy, Inductively Coupled Plasma – Mass Spectrometry (ICP-MS) and High-Performance Liquid Chromatography (HPLC). In this way, identity and potency can be established.
Microbiological testing: Next, the raw material must be tested for microbiological compliance to verify it does not contain dangerous levels of microorganisms such as E. coli. Special equipment in a separate microbiological laboratory will be required for this purpose. Since all CDMOs do not always have an in-house microbiological lab, the raw material may need to be sent to a third-party lab for micro testing. Some CDMOs do not even have a standard analytical lab, so all testing must be conducted by a third-party lab. You must factor in additional time (maybe 2 weeks) when a raw material is sent out to a third-party lab for testing.
Heavy metal testing: Finally, heavy metal testing for lead, mercury, cadmium, and arsenic must also be conducted. Not only is this required and the right thing to do, but California Prop 65 requirements are associated with some hefty fines if your product fails to meet its more stringent heavy metal requirements.
Timeline: The aforementioned testing may take anywhere from 1-2 weeks depending upon whether the CDMO has in-house laboratory facilities, or if the raw materials must be sent to a third-party lab. Once the raw materials have passed testing they can be released into inventory on the same day.
Conducting Bench Work
Before receiving the purchase order, the CDMO will proceed with bench work, also known as an R&D batch. This is where the raw materials will all be mixed, and a limited number of tablets and capsules will be produced in the lab to ascertain that the formulation will work in a finished dosage form. Depending upon the situation, the CDMO may provide the customer with samples of the tablets/capsules to evaluate them. Once the customer approves the samples, the CDMO can then move on to the production batch.
Timeline: Since bench work takes place prior to receiving the purchase order, it does not add to the timeline.
Manufacturing Production Batch
The production run is when the finished product is manufactured, and it involves several key steps, including additional testing. This testing encompasses uniformity of mix, content uniformity, and dissolution testing.
Uniformity of mix: All the raw materials that comprise a given dietary supplement are mixed in a large-scale commercial mixer. During this process, the raw materials must be completely and uniformly mixed to ensure an even distribution of each specified vitamin, mineral, herb, etc., (“nutrients”) throughout the entire batch. A uniform mix is important since we want all the capsules, tablets, or powders made from a batch of raw materials to consistently have the proper, pre-determined amount of nutrients in them.
Content uniformity (spot testing tablet/capsule weight): After determining the mix is uniform, the next step is to ensure each tablet and capsule has the correct weight to verify its nutrient potency. This is known as “content uniformity.” While capsules are being filled or tablets are being punched during the manufacturing process, their weight is regularly spot-tested. In addition, to capturing weight uniformity data, additional data regarding thickness and hardness is also recorded. For both capsules and tablets, content uniformity is charted to ensure results within the specified range. If for any reason, there is an unacceptable variation from the product specifications for content uniformity (weight, thickness, density), the formulation is then revised to correct the situation.
Dissolution testing: Dissolution testing is a process whereby the capsule or tablet is put into temperature-controlled water and then agitated (moved around in a small container) to simulate the muscular action of digestion. If the tablets or capsules dissolve within 45 minutes in water, there is a reasonable level of assurance that they will similarly dissolve in the human digestive tract, allowing the nutrients to be readily available for absorption.
Timeline: The production run and associated will likely take about 1 week.
Testing the Production Batch
Once the finished tablets from the production batch have been made, a repeat for the same types of tests done on the raw materials is performed, including identity and potency, microbiological compliance, and heavy metal compliance. The CDMO will then produce a certificate of analysis (COA) which will be sent to the brand owner. Once the brand owner approves the COA, the finished product can be shipped to the customer’s distribution facility, and the manufacturing process is complete. The brand owner may also ask for stability testing to be conducted during this step in the process.
Stability testing: If expiration dates appear on the label of a product, then stability testing must be conducted. Stability testing helps identify which nutrients are most vulnerable to damage and to what degree potency is affected. By accounting for such variables as specific ingredients, dosage form, packaging, and storage conditions, it can determine how much of an increase in the potency for a given nutrient is needed to compensate for potency losses over time.
There are two types of stability testing: accelerated stability and ambient stability:
- Accelerated stability: During accelerated stability, a dietary supplement in its intended packaging is placed inside an environmental chamber that controls temperature and humidity. This chamber will create conditions that are designed to accelerate the normal aging of a product. For example, if a product spends one month in the accelerated machine, it may be the approximate equivalent of six months of aging time. When the product is removed, we can test it for potency loss and other effects.
- Ambient stability: Ambient stability is determined by taking a sample of a packaged product we manufacture and holding it in a retain room under controlled, ambient temperature and humidity. The retain room is used to correlate and confirm shelf-life results from accelerated testing. At regular intervals during its shelf life, a product is pulled from the retain room and tested for potency which is then compared to the accelerated aging studies.
Timeline: Testing of the production batch may take 1-2 weeks. This does not include the time associated with stability testing which many brand owners choose to conduct after the product has been shipped, relying on the CDMOs expertise with the ingredients in the supplement to establish expiration dating, and then making any adjustments that may be necessary on the next production run.
Packaging and Labeling
It is well-established that an attractive supplement packaging design—and/or packaging with other features such as sustainability—can catch consumer’s attention and make it more likely that they’ll consider purchasing your product in the first instance. At the same time, deviation from standard packaging options is associated with increased costs and longer lead times. For example, the use of sustainable packaging (e.g., packaging made from recycled materials) is certainly more expensive than standard packaging, but at the same time trends have shown that many consumers prefer such packaging due to environmental concerns.
Sometimes brand owners want to utilize bottles with unique shapes or containers not typically used in the dietary supplement industry (such as containers normally used in the cosmetic industry for creams). When considering these unusual packaging options, it is important to see if the containers are suitable for running on an automated packaging line. If they are not, that means they’ll have to be hand-filled, which will substantially increase costs, as well as lead times. Perhaps the best place to get creative concerning packaging is with unique, attractive labels that are still capable of being automatically applied to bottles. The incremental cost of a unique label will still be substantially less expensive than utilizing bottles with unique shapes.
Timeline: Assuming the use of standard packaging options, packaging and labeling will likely take about 1-2 days. The use of unique, non-standard packing options may increase the timeframe by up to 2 weeks.
Shipping the Finished Product
Shipping may be accomplished by different methods depending upon the shipping destination. Typical methods include:
- Ground shipping: This is a reliable and cost-effective option to move packages and goods within a country or region through several carriers such as FedEx, UPS, and USPS. The primary advantage of ground shipping is that it’s generally less expensive than air or ocean freight, and it offers various delivery options such as next-day, two-day, or standard delivery, depending on shipment urgency.
- Air freight: Air shipping is a fast and efficient shipping method, ideal when you need to move products quickly. Although it is more expensive than ground shipping, it is often more cost-effective than other shipping methods such as sea freight for international orders. Air freight can sometimes bypass customs delays and other logistical hurdles.
- Ocean freight: Shipping by sea is a cost-effective method of shipping when you have a very large order to transport. Ocean freight is slower than air or ground shipping, but it is often the most cost-effective option for international deliveries. It offers various container sizes and shipping options, including full container load, or less than container load, depending on the size and quantity of the shipment.
Timeline: Standard ground shipping typically takes about a week to reach its destination. Air freight may take a few days, and ocean freight may take a few weeks.
Factors Influencing the Supplement Manufacturing Time
Numerous factors may influence supplement manufacturing time. Many of these have already been discussed, but a few to consider include formulation complexity and customization, production scale and manufacturing technology, quality control and testing, manufacturer experience and expertise, supply chain, and minimum order quantity.
Formulation Complexity and Customization
The more complex and customized the formulation, the more time it will likely take to develop and manufacture. One scenario to consider is ingredients don’t play well together.
For example, you may want to combine probiotics with other nutraceuticals. However, many probiotics are sensitive to moisture, and if combined with a nutraceutical with water activity that is just a little bit higher than desired, it can deactivate the probiotic in the formula.
Another scenario involves incorporating ingredients with a bitter aftertaste or other undesirable flavor elements into delivery forms such as powders, chewable tablets, melts, or lozenges. This necessitates using bitter masking agents and/or additional flavoring agents to compensate, which, in turn, requires extra time.
Yet another scenario involves using unique nutraceuticals sourced internationally. Acquiring these ingredients often takes longer due to language barriers, as well as potential delays with shipping and customs clearance.
The bottom line is each additional ingredient adds complexity, requiring more time for sourcing, testing, and integration. Unique formulas also require custom development and testing, extending the timeline compared to standard products.
Production Scale and Manufacturing Technology
Production scale and manufacturing technology can also affect the supplement manufacturing timeline. Consider that larger batches require more equipment, personnel, and production time, while smaller batches offer a quicker turnaround but may be less cost-effective.
The microencapsulation, granulation, and/or agglomeration of ingredients will take extra time, but it is often well worth it since it tends to result in a better-quality finished product.
Quality Control and Testing
Quality control and testing undoubtedly extend the overall production time, but they are essential steps that should never be overlooked. It’s crucial to avoid partnering with a CDMO that is willing to cut corners on these critical processes, as this is a significant red flag. For more expert insights on selecting the right supplement contract development and manufacturing organization, read the article written by our CEO and President, Patrick Brueggman.
You may decide you want additional tests to be run on your product that aren’t typical. For example, you may want to conduct allergen testing, pesticide testing, or ORAC testing (an antioxidant assay). While these tests have value, they can also add a couple of extra weeks to your timeline.
Manufacturer Experience and Expertise
There are many CDMOs available to choose from, but when you narrow it down to those with decades of experience, only a few remain. It’s highly beneficial to work with a CDMO that has extensive experience in developing and manufacturing dietary supplements. Experienced CDMOs are familiar with regulatory requirements, which helps reduce delays. They also have optimized production processes that lead to faster turnaround times and can quickly address any production challenges, ensuring timely delivery of your finished products.
Supply Chain
There are a few ways in which production scale and manufacturing technology can affect the supplement manufacturing timeline. For example, ingredient shortages or disruptions can significantly delay production. Strong supplier relationships are crucial, which is another good reason to work with an experienced CDMO. Delays in obtaining packaging materials can also halt production. Again, an experienced CDMO with diversified sourcing and inventory management is essential for keeping the production schedule on track. Likewise, efficient logistics and reliable transportation partners ensure the timely delivery of ingredients and finished products.
Are Short Lead Times for Manufacturing Supplements Real?
So, is it realistic to expect short lead times for manufacturing supplements? No—at least if you want to do it right.
The adage, “Short cuts make longer delays”, applies here. The first time a new dietary supplement formulation is manufactured, it can take up to 14 to 18 weeks. Repeat orders are quicker since sourcing and benchwork have previously been established. Also, single ingredient formulas also take less development and manufacturing time.
You should have a lot of questions for a CDMO offering a lead time as short as 4 weeks. As you know from having read this article, it can take as long as that or longer just to obtain certain raw materials. It’s better to do it right the first time than to work with a CDMO that cuts corners, promising short lead times. Such CDMOs do not tend to have the best reputation in the industry. In any case, make sure to carefully research the background, capabilities, and certifications of any CDMO you are considering.
How to Set Proper Expectations Around Time with Your Supplement Manufacturer?
So, how do you set proper expectations around the manufacturing time of supplements with your CDMO? There is a three-part answer to this question.
First, read and re-read this article to gain a more complete understanding of the supplement manufacturing process, its multiple steps, the timelines associated with those steps, and additional factors that may influence the time it takes to manufacture the product.
Second, consider adding buffer periods while making tentative turnaround timelines for unforeseen delays like supply chain disruptions.
Third, speak to your CDMO before the process begins and discuss your expectations. Do they agree with your expectations? If not, what would they change? Also, be sure to maintain open communication with your CDMO throughout the manufacturing process.
How to Optimize for Efficient Turnaround Timelines
Now that you’ve set realistic expectations, there are a few things you can do to optimize for efficient turnaround timelines.
First, choose a contract supplement manufacturer with proven expertise and efficiency in your specific type of supplement. Next, plan the development process well in advance to prevent last-minute delays. Additionally, remain flexible by having backup options for sourcing or packaging to address potential hurdles. Finally, ensure clear and consistent communication with all stakeholders throughout the process.
How Can Vitaquest Help You Manufacture High-Quality Supplements?
A good CDMO can significantly enhance your experience in manufacturing quality supplements for your brand. Vitaquest is a CDMO with over 45 years of experience in providing nutraceutical businesses with top-quality supplement formulation design, contract manufacturing, packaging, and fulfillment services. Whether you’re new to the industry or looking to expand your product range, Vitaquest has the expertise, state-of-the-art facilities, and solutions to efficiently turn your dietary supplement concept into reality. We specialize in developing and manufacturing high-quality dietary supplements and offer a variety of dosage forms, including capsules, tablets, and powders.
Vitaquest also has expertise in domestic and international regulatory standards. We are GMP-certified by NSF, assuring brand owners and consumers of our commitment to complying with industry regulations and standards. In addition, Vitaquest can offer Kosher, Halal, and certified organic products, and FSSC 22000 certification for food safety.
Concluding Thoughts
Keep in mind that—the first time out—the realistic, expected lead time to manufacture a dietary supplement is 14 to 18 weeks. Furthermore, you must work with an experienced CDMO that does it right the first time, rather than one offering short lead times that may result in a poor-quality product. Use the insights you’ve gained in reading this article to conduct thorough research, make informed decisions, and navigate the cost landscape effectively.
Are you ready to move forward with creating high-quality dietary supplements for your brand? If so, call 800-526-9095 to speak with one of our knowledgeable sales executives or request a competitive nutraceutical manufacturing price quote if you’ve already finalized your project requirements!
