Bespoke probiotic supplement manufacturing

Named probiotic strains in capsules, sticks, powders and gummies

Every custom probiotic we develop for premium brands, whether capsules, sachets and stick packs, powders, gummies, tablets or chewables, is made in our Leicester facility. Among probiotic manufacturers, we focus on defined strains that compete on evidence: we specify every strain by name, dose it at the count its human trials used, and set the count each product must still hold at the end of its shelf life. Each batch ships with a certificate of analysis showing its live count. Probiotics sit within our gut health supplement manufacturing range.

Probiotics are live microorganisms that, when administered in adequate amounts, confer a health benefit on the host (Hill and colleagues, 2014). The same consensus concluded that some benefits can be expected across well-studied species, while others belong to a single strain. Every specification we write names the genus, the species and the strain designation.

• Lactobacilli and bifidobacteria. The core of most formulas, supplied as freeze-dried concentrates. Their names changed in 2020, when the genus Lactobacillus was split into 25 genera (Zheng and colleagues, 2020): Lactobacillus rhamnosus GG, for example, is now Lacticaseibacillus rhamnosus GG. Our labels and specifications use the current names.
• Spore-formers. Bacillus species survive heat, acid and drying as spores, which makes them the natural choice for gummies, powders and drinks. The EU novel food catalogue lists Bacillus coagulans, now named Heyndrickxia coagulans, as not novel in food supplements but novel in other foods (European Commission, July 2025), so a spore probiotic in a snack bar faces different rules from one in a capsule.
• Next-generation strains. Pasteurised Akkermansia muciniphila is an authorised novel food in the EU, and other next-generation species follow the same route. Our Akkermansia and postbiotic pages will cover them.

The EU novel food catalogue lists bacteria by species, and some, including Lactobacillus gasseri and Bacillus subtilis subsp. natto, are not novel only in food supplements. We screen each strain for novel food status in-house against the public registers, for each market, before a formula is fixed.

Synbiotics, sports and women's probiotics

A synbiotic is a mixture of live microorganisms and substrates selectively utilised by host microorganisms that confers a health benefit (Swanson and colleagues, 2020). In a complementary synbiotic, the strain and the prebiotic each meet their own criteria; in a synergistic one, the substrate is chosen to feed the strain it travels with. Our fibre and prebiotic supplement manufacturing page covers the substrates. Sports probiotics rest on strain-specific trials in active people, as the International Society of Sports Nutrition's position stand sets out (Jäger and colleagues, 2019), and they suit our sports nutrition manufacturing programmes. Women's probiotics build on research showing that most vaginal microbial communities are dominated by one of four Lactobacillus species (Ravel and colleagues, 2011), and sit within our women's health supplement manufacturing. Neither group carries an authorised claim in GB or the EU.

CFU at the end of shelf life, not at manufacture

CFU counts and national floors

Probiotic doses are counted in colony forming units (CFU) of live cells, and the right count is the one the strain's trials used. Some national rules set a floor: Italy's guidelines expect at least 1 billion live cells a day (Fenster and colleagues, 2019), and France accepts the category name for products supplying 10 million to 1 billion live cells of a strain a day (EHPM, 2024). We set the label count at the end of shelf life, not at manufacture, as Italy's guidelines expect.

Survival to the gut

Stomach acid and bile kill a share of live cells before they reach the intestine. Bifidobacteria are among the more acid-sensitive groups, while spores pass through largely intact. We protect sensitive strains with acid-resistant capsules, enteric coating or microencapsulation, and compare options with gastric simulation tests, which approximate passage through the stomach (Fenster and colleagues, 2019).

Water activity, shells and packs

Water activity matters most, followed closely by storage temperature. A review of probiotic production advises keeping total water activity below 0.2, and ideally below 0.15 for long shelf lives, and adding an overage sized from each strain's own stability data (Fenster and colleagues, 2019). Fillers, fibres and botanical extracts all bring water into a blend, so we specify low-moisture grades. Shells matter too: gelatine capsules hold 13% to 16% water against 4% to 6% for HPMC (Al-Tabakha, 2010), which makes HPMC the natural shell for probiotics. Tablet compression cuts live counts, and the same review advises against PET bottles; high-barrier packs with desiccant protect the count.

Live cells and their neighbours

Live cells react to their neighbours. Acidic fruit powders, hygroscopic minerals and some botanical extracts lower the survival of sensitive strains, while the right fibre supports a synergistic synbiotic. We screen interactions by counting a rehydrated blend before and after a hold, as the review describes, and run real-time stability at the storage conditions printed on your label.

Capsules as the reference format, gummies for spore-formers

• Capsules are the reference format: HPMC or acid-resistant shells, sealed in high-barrier packs with desiccant, and GMP certified. See capsule manufacturing.
• Sachets and stick packs hold one dose each in foil laminate, so no dose is exposed by repeated opening; they suit powders and synbiotics and are made in Leicester. See sachet and stick pack manufacturing.
• Probiotic powders in tubs suit spore-formers and high-count blends with fibre, made in Leicester. Every opening lets in moist air, so the overage allows for it. See powder supplement manufacturing.
• Gummies suit spore-forming strains, because heat and water in gummy processing kill most lactic acid bacteria; they are GMP certified, with a live count on every batch. See gummy manufacturing.
• Drinks and shots keep live cultures dry in a dispensing cap until the bottle is opened.
• Tablets and chewables are made in-house, with compression loss built into the overage.

Why probiotic labels name the strain, not the category

As of October 2026, no health claim is authorised for probiotics in GB or the EU. The only live-culture claim on the register is for yoghurt and fermented milk, which improve lactose digestion of the product in individuals who have difficulty digesting lactose, with at least 100 million CFU of named starter cultures per gram.

• Great Britain. "Probiotic" is regarded as a health claim, acceptable only alongside a closely related authorised claim (CAP, 2024). No such claim exists for supplements, so labels name the strains in the ingredient list and take authorised claims from added nutrients, such as "Vitamin D contributes to the normal function of the immune system", for food that is at least a source of vitamin D.
• European Union. The European Commission regards "probiotic" as a health claim, but at least eight member states accept the term under national conditions, several as a category name for food supplements: Italy, the Czech Republic, Bulgaria, Spain, the Netherlands, Denmark, France and Poland (EHPM, 2024). A product sold across the EU uses strain names or market-specific labels.
• United States. Live microbials are dietary ingredients, and FDA does not define "probiotic" as a regulatory category. Labels declare live microbials by weight, and FDA's draft guidance lets them add a CFU count that includes live cells only (FDA, 2018). Structure and function claims need competent and reliable evidence, notification to FDA and the standard disclaimer. A strain not marketed in the US before 15 October 1994, and not present in the food supply as an article used for food in an unaltered form, needs a new dietary ingredient notification to FDA before launch.

We prepare products and documents for the UK, the EU and the US: one strain specification and test plan, with label copy and claims written for each market.

Fermentation, freeze-drying and a cold chain to the capsule

Strains are grown by specialist culture producers, and every supplier passes our approval process before any material is used. The process runs in seven steps:

1. Fermentation. The producer grows the strain in a defined medium under controlled temperature and pH.
2. Concentration. Centrifugation separates the cells from the spent medium (Fenster and colleagues, 2019).
3. Protection and drying. Cryoprotectants limit ice damage, and the concentrate is freeze-dried, milled and counted.
4. Cold chain. Concentrates travel and are stored chilled or frozen, as the producer's specification sets.
5. Dispensing and blending. We specify humidity limits for dispensing and blend the culture with dry, low water activity excipients, adding the overage set from stability data.
6. Filling and sealing. The blend is encapsulated or filled into stick packs, then sealed in high-barrier packaging, with desiccant where the format needs it.
7. Label check and release. Labels are verified on every batch, the critical control point in our HACCP plan.

The critical steps are water activity and humidity control, temperature from goods-in to dispatch, blend uniformity so every capsule carries its count, and allergen control. Culture media can carry milk or soy, which our allergen management plan, with yellow colour coding, controls from goods-in to label. Each product type has its own HACCP study, reviewed every year.

Proof of the live count, the first ask of probiotic manufacturers

Ask for the specification and the evidence behind the count on the label. Ours set the tests for each product and market, and accredited partner laboratories (ISO/IEC 17025) test every batch as part of every order, as our testing and batch release page explains.

• Identity: strain identity from the culture producer, by genome sequencing or strain-specific methods, held in the supplier file.
• Count: live cells by plate count in CFU; flow cytometry, standardised for lactic acid bacteria in ISO 19344, also counts live cells that do not form colonies.
• Stability: real-time studies at label storage conditions, with accelerated studies to guide early decisions, so the count holds to the end of shelf life.
• Water activity and moisture of the blend and the finished product.
• Microbiology: pathogens such as Salmonella and Listeria, and contaminants such as yeasts and moulds.

Every batch is released by quality control against its specification, and nothing is dispatched without quality control sign-off. We keep three retained samples per batch for shelf life plus one year, and a full mock recall, forward and backward with mass balance, runs in seconds. Every batch comes with a certificate of analysis showing its live count and a batch release confirmation, and development adds the strain specification, the stability report behind your shelf life and a claims review for each market. We are ISO 9001, HACCP and GMP certified by BSI, and FDA registered. BRCGS implementation under way, certification expected in early 2027. Your formula is yours, including its strain specification and stability data. Start your project with your strain, count and markets, and we build the formula around them.

References: Hill and colleagues, Nature Reviews Gastroenterology and Hepatology (2014); Zheng and colleagues, International Journal of Systematic and Evolutionary Microbiology (2020); Swanson and colleagues, Nature Reviews Gastroenterology and Hepatology (2020); Fenster and colleagues, Microorganisms (2019); Jäger and colleagues, Journal of the International Society of Sports Nutrition (2019); Ravel and colleagues, Proceedings of the National Academy of Sciences (2011); US FDA, draft guidance on quantitative labeling of dietary supplements containing live microbials (2018); EHPM, position paper on the use of the term probiotics in the EU (2024).