Paragon Labs USA

Probiotics Capsule

Revolutionizing the Probiotics Market with New Technology

In 2012, the global probiotics market was exploding at an unprecedented growth rate of 7.56%, rising from $29.9 billion to over $50 billion today. However, the market was saturated with probiotic companies trying to create product differentiation through marketing and branding instead of quality and technology. This overload of brands marketing identical products created confusion among consumers who were still learning about the benefits of probiotics.

Probiotics are living microorganisms that provide numerous health benefits (such as promoting gut health) and are primarily available in the form of dietary supplements. Most probiotic products are typically homogenous because they bring good bacteria into the body and distribute them into the body’s system. The issue is every body is different with its makeup of bacteria, which means a standard probiotic supplement may not be as, if at all, effective for some people.

A small, bootstrapping startup noticed this opportunity in the market and sought to develop a step-change in probiotic technology that could provide meaningful benefits for consumers. The startup landed on a technology that would allow the probiotics to strengthen the good bacteria already in the body to maintain the body’s bacteria composition. Other benefits also include being an anti-inflammatory to lactose and reducing the risk of yeast infection. It was unlike anything available in the market.

With this new technology, the small business was ready to get started on developing a finished product. The plan was to produce several product forms to enhance consumer compliance, such as capsules (the standard for the probiotic segment) and chewable tablets. But, the company realized it did not have all the necessary capabilities to develop its innovative ingredient technology into a finished product, sparking the search for a GMP product development and manufacturing partner to assist in this endeavor.

To identify the perfect partner, the startup recognized the special capabilities required to develop its products. In the end, Paragon was the chosen contract manufacturer for several reasons:

Specialty Ingredient Accommodation

A specific ingredient was integral for the small startup to differentiate itself from its competitors, but many contract manufacturers do not have the capabilities to properly handle unique probiotic ingredients. In its Standard Operating Procedures, Paragon utilized its allergen program, which outlines the identification of top-tier food allergens and applicable controls necessary for:


All ingredients are reviewed during product development to pinpoint known allergens or materials of concern

Receiving and Sampling

Once received, allergenic materials are sampled in the isolated sampling room, away from other raw materials


All allergens are stored separately from other raw materials either by racks, plastic, or a separator to prevent cross-contamination

Picking, Weighing, and Staging

Finished products containing allergenic ingredients are labeled with a “CONTAINS ALLERGENS” label and are handled separately from non-allergenic products

Production and Packaging

During the manufacturing process of allergenic products, traffic patterns of raw materials, products, packaging components, and employees are limited as no other products are allowed in the processing room at any given time


After coming into contact with an allergen or product containing an allergen, all equipment is washed, sanitized, and cleared by the quality team before changing to another product

Expertise in Product Development Assistance

 With its Proven Process to lead the way, Paragon would have no issue turning this idea into a finished product. The startup already knew the capsule and tablet forms it wanted and the necessary ingredients to make the probiotic, so Paragon needed to formulate and produce the finished product.

During the manufacturing process, Paragon tested all raw materials needed to ensure quality, as well as finalized the specifications of the order. Paragon also accommodated to the startup by producing smaller batch sizes and pilot runs, which came as an advantage in the long-term as this allowed time to perfect the probiotic formula.

After the finished product was 100% visually inspected, the quality control and assurance team gave the product its stamp of approval.

With the finished product ready for shipment, Paragon could now provide product development guidance and counsel to the startup, which has improved its operations over the years.

Experience in Collaborating with Secondary Suppliers

The probiotics startup was familiar with many moving parts in its process, so it needed a partner with strong experience in working with outside suppliers.

Paragon partners with a variety of suppliers to source the best ingredients and raw materials. After working with so many of them, Paragon established a protocol to qualify secondary suppliers. The qualifications look deep into different areas of the supplier to see if the supplier shares the same values as Paragon. These areas include quality systems, manufacturing practices, food safety, material control, allergen control, sanitation, certifications, training, and more.

Overall, the delivery of the finished product was a four-month process. Paragon exceeded in providing the right formula and packaging while bringing all the moving parts together to work harmoniously.

Since then, Paragon has continued to surpass expectations as the startup has seen significant consumer acceptance of the product, especially in the feminine care segment, with no defective products or consumer adverse incidents.

“The decision to partner with Paragon was a no-brainer as our company could not have achieved our goals or reached the level of success without their assistance. Their hands-on involvement and accessible management, coupled with the capabilities of their team members and thorough QC processes, made an incredible difference for our company.”

President of Bootstrapping Probiotic Startup

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