Summary
Build Your Brand is an FDA-registered, GMP-certified contract manufacturer specializing in probiotic supplements and private label probiotic supplements. Based in the USA with over 17 years of experience and 500+ brands served, we offer turnkey manufacturing from custom formulation through packaging and fulfillment. Our facility maintains NSF International certification and all products undergo third-party testing through ISO 17025 accredited laboratories.
Services
- Custom formulation and product development for probiotic supplements
- Low minimum order quantities starting at 300 units
- Third-party laboratory testing for potency, purity, and safety
- Full packaging design, label compliance, and fulfillment services
- Amazon FBA prep and direct-to-consumer shipping
Frequently Asked Questions
Which probiotic strains survive gummy manufacturing heat?
Only spore-formers. Bacillus coagulans GBI-30 6086 and Bacillus subtilis DE111 produce endospores that survive the 75-85C gummy cook step and hold label-claim CFU through 12 months at room temperature. Live Lactobacillus and Bifidobacterium strains do not survive gummy manufacture in any meaningful potency and should be formulated as vegcaps, stick packs, or liquid drops instead.
What is the difference between deposit-coded and generic-named strains?
A deposit code (NCFM, GG, BB-12, DSM 17938) identifies the exact strain isolate held at a recognised culture collection (DSM, ATCC, CNCM) and tied to a specific supplier (Chr. Hansen, Valio, Morinaga, BioGaia). Generic 'Lactobacillus acidophilus' on a label can be any acidophilus isolate from any source and carries no clinical equivalence. Deposit-coded strains are what published clinical trials actually used.
How long do CFU counts hold at room temperature?
Our retention specification is 80% of label-claim CFU at 24 months when stored at or below 25C in opaque HDPE with 1g silica desiccant, or in foil-back HPMC blister packs. Above 25C and above 60% relative humidity, retention drops sharply for live strains (Lactobacillus, Bifidobacterium) and modestly for spore-formers (Bacillus). Refrigeration extends retention but is not required for the strains and packaging we ship.
Can we add prebiotic fibre, and do you ferment the strains in house?
Yes on prebiotic stacks. We pair any live strain with FOS, inulin, or partially hydrolysed guar gum (PHGG) in the same dose form. Strain fermentation is handled at the licensor (DSM, Chr. Hansen, Valio, Morinaga, BioGaia, Ganeden, Deerland, Probi); we receive the strain as a freeze-dried concentrate, blend with excipients and prebiotic, then encapsulate or compress under cGMP at the Shenzhen facility.
Do you provide a 24-month stability dataset before production?
Yes, on every custom formulation. The pilot batch is enrolled into accelerated stability per ICH Q1A(R2) at 30C/65% RH plus a real-time arm at 25C/60% RH, with USP <2202> enumeration at T0, T6, T12, T24. The dataset accompanies every lot COA and is the documentation we hand your QA team if a retailer audits CFU substantiation. Stock library SKUs ship with the existing dataset attached.
What is the smallest MOQ for a custom strain blend?
500 units for vegcaps and gummies, 1,000 units for stick packs and liquid drops. Custom blends use a maximum of 5 active strains per dose form to protect potency targets through the stability window. The 500 unit floor is the same whether you pick a single strain (BB-12 at 10B CFU) or a 5-strain immune blend (NCFM + GG + BB-12 + BB536 + Lp299v).
How are CFU counts verified, plate count or flow cytometry?
USP <2202> plate-count enumeration is the default and the regulator-recognised reference method for label-claim CFU. Flow cytometry (total cell count, AFU active fluorescent units) is available for strains where the licensor has validated the method and provided the conversion factor. The COA always cites the method used; we do not blend the two.
Do you handle infant probiotics, drops or stick packs?
Yes. L. reuteri DSM 17938 (BioGaia licensor, 100M CFU per serving as fixed dose) is the standard infant strain and ships as liquid drops in MCT or sunflower-oil base, 5mL squeeze bottle with calibrated dropper. Stick-pack sachet format is available for older infants and travel positioning. Both formats run through the same stability and contaminant panel as adult SKUs.
Private Label Probiotic Manufacturer | 10+ Deposit-Coded Strains, CFU-Verified per Lot
Launch your probiotic brand with 10+ deposit-coded strains (NCFM, GG, BB-12, BB536, Lp299v), CFU verified per lot via USP <2202> enumeration, 24-month accelerated stability dataset on file. Vegcaps, sachets, spore-former gummies, infant drops. 500 unit MOQ.
- Deposit-Coded Strains in Library
- 10+
- Retention Guarantee at 24 Months
- 80% CFU
- Unit MOQ Standard
- 500
- Enumeration Method per Lot
- USP <2202>
Category snapshot · 2026-05-07
+8.7% probiotic CAGR through 2027
$78B global probiotics by 2027
- Probiotic supplements TAM
- $78B by 2027
- Annual growth
- +8.7%
- Shelf-stable preference
- 84%
- Shelf-stable formulas preferred by 84% of buyers
- Strain-specific marketing (e.g., Bifidobacterium longum 35624) drives premium pricing
Formulation Library: Deposit-Coded Probiotic Strains + CFU-Verified Manufacturing
The global probiotic supplement market is projected to surpass $111 billion by 2030, growing on the back of post-antibiotic gut recovery, immune positioning, and infant/elderly digestive comfort categories. Most contract manufacturers in this space talk in generic terms (Lactobacillus, Bifidobacterium, 10 billion CFU) and leave the supplier deposit code off the label, which is where regulators and informed buyers look first. We build private label probiotic SKUs against named, deposit-coded strains (NCFM from DSM, GG from Valio, BB-12 from Chr. Hansen, BB536 from Morinaga) with batch-level CFU verification and a 24-month stability dataset on file before your first commercial run. The structural difference is documentation depth, not marketing language.
Our active strain library covers the four genera that carry the bulk of published clinical work: Lactobacillus (acidophilus NCFM, rhamnosus GG, plantarum Lp299v, casei Shirota, reuteri DSM 17938), Bifidobacterium (lactis BB-12, longum BB536), Bacillus (coagulans GBI-30 6086, subtilis DE111), and the yeast Saccharomyces boulardii CNCM I-745. Each entry in the library carries its deposit code, validated dose band, format compatibility, and an indication framed for FTC-safe structure-function copy (digestive comfort, immune support, transit regularity), never disease claims. Custom blends use a maximum of 5 active strains per capsule to protect potency targets through the stability window.
Format compatibility is dictated by the strain. Vegcap (HPMC) blister packs are the default carrier for live Lactobacillus and Bifidobacterium because the foil-back blister protects against moisture ingress, which is the dominant CFU killer at room temperature. Stick-pack sachets with microencapsulated cores are available for travel-format and refrigerated retail. Gummy format is restricted to spore-formers (Bacillus coagulans GBI-30 6086 and Bacillus subtilis DE111), whose endospores survive the 75-85C cook step and 12 months on a shelf without CFU collapse. Liquid drops in MCT or sunflower-oil base are the standard infant carrier for L. reuteri DSM 17938. Synbiotic stacks pair any live strain with prebiotic FOS, inulin, or partially hydrolysed guar gum (PHGG) in the same dose.
CFU retention is the moat. Every formulation runs an accelerated stability protocol per ICH Q1A(R2) at 30C/65% relative humidity, with CFU enumeration by USP <2202> plate count (or flow cytometry for total cell count where the strain is licensor-validated for that method) at T0, T6, T12, and T24 month timepoints. The ISO 17025 accredited contract lab on file releases a stability dataset before your first commercial production. Our retention specification is 80% of label-claim CFU at 24 months when stored at or below 25C in opaque HDPE bottles with 1g silica desiccant, or in foil-back HPMC blister packs. Strains that fall below 80% retention at T12 in accelerated conditions are reformulated (overage adjusted, moisture barrier upgraded, or excipient blend changed) before commercial release. Competitors do not publish this protocol.
Our Manufacturing Process
From initial concept to finished product, every step is managed under one roof with dedicated quality oversight and transparent communication.
Strain Selection & Formulation
We map your positioning (immune, gut comfort, infant, women's intimate, post-antibiotic) to deposit-coded strains in the library and build the dose schedule against published clinical evidence. Excipient selection (microcrystalline cellulose, magnesium stearate alternatives, silica desiccant load) is fixed at this stage because excipient water activity drives CFU loss more than ambient temperature within the 20-25C band.
Pilot Batch + CFU Verification
A 5-10 kg pilot batch is produced under cGMP (21 CFR Part 111) at the Shenzhen facility, with CFU enumeration on the finished dose form by USP <2202> plate-count method through the ISO 17025 accredited lab. Pilot release requires CFU at or above 120% of label claim (the standard overage that compensates for projected 24-month decay) plus contaminant panel (E. coli, Salmonella, S. aureus, yeast and mould) within USP limits.
Stability Run (12-24 month accelerated)
The pilot is enrolled into accelerated stability at 30C/65% RH per ICH Q1A(R2), plus a real-time arm at 25C/60% RH for label-claim validation. Plate counts run at T0, T6, T12, and T24 months. The dataset accompanies every COA shipped to your 3PL and is the documentation we hand to your QA team if a retailer audits CFU substantiation. Synbiotic and gummy formats run their own format-specific arm.
Production with COA per Lot
Commercial production runs at the 500 unit MOQ floor for vegcaps and gummies, 1,000 for stick packs and liquid drops. Each lot ships with a COA listing CFU per dose by strain, moisture content (target below 5%), water activity (below 0.3 Aw), and the contaminant panel. Bottles are sealed with induction liner plus desiccant; blister packs use aluminum-aluminum foil. Sea freight is 30-45 business days; air freight is 5-10.
Get the probiotic strain & MOQ sheet
FDA-registered manufacturing. MOQ from 500 units. Quote returned within 24 hours.
Key Benefits for Your Brand
Every aspect of our probiotic supplements manufacturing is designed to accelerate your time-to-market while maintaining uncompromising quality standards.
Deposit-Coded Strains, Not Generic Names
Every strain in the library is named with its supplier deposit code (NCFM, GG, BB-12, BB536, Lp299v, DSM 17938, CNCM I-745, GBI-30 6086, DE111), giving your label the substantiation regulators and informed buyers check first. Generic 'Lactobacillus acidophilus' on a competitor SKU does not survive the same scrutiny.
Spore-Former Gummy Capability
Bacillus coagulans GBI-30 6086 and Bacillus subtilis DE111 endospores survive the 75-85C gummy cook step and hold label claim through 12 months at room temperature. We are one of the few facilities running probiotic gummy SKUs without CFU collapse, against the standard $6,000 custom shape mold fee if you want a proprietary form.
CFU Retention Guarantee
80% of label-claim CFU at 24 months when stored at or below 25C in opaque HDPE with 1g desiccant, or in foil-back HPMC blister packs. Backed by a USP <2202> enumeration dataset at T0, T6, T12, T24 timepoints from an ISO 17025 accredited lab on file before your first commercial run.
Synbiotic Formulation (Probiotic + Prebiotic)
Pair any live strain with FOS, inulin, or partially hydrolysed guar gum (PHGG) in the same capsule, stick pack, or gummy. The prebiotic fibre is sourced and tested for moisture independently to protect CFU stability in the finished dose form. Synbiotic positioning supports premium shelf pricing without rebuilding the label.
Blister-Packed for CFU Stability
Foil-back HPMC blister packs are the default for sensitive Lactobacillus and Bifidobacterium SKUs. The blister isolates each dose from atmospheric moisture (the dominant CFU killer at room temperature), extending real-world shelf retention beyond what HDPE bottles deliver in humid climates. Bottle format remains available for cost-sensitive runs.
Frequently Asked Questions
Common questions about our probiotic supplements private label manufacturing services.
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