Bacillus clausii

Bacillus clausii

Shouchella (Bacillus) clausii · 2 billion spores per 5 mL

Alkaliphilic Bacillus clausii spore concentrate and ready-to-drink 2 billion spore suspension, including the four-strain O/C, N/R, SIN, T combination. Vegan, non-GMO. Bulk and contract fill from India.

Specifications

OrganismBacillus clausii. Reclassified Alkalihalobacillus clausii (Patel and Gupta, 2020), then Shouchella clausii (Joshi et al., 2021)
Strains availableThe four-strain O/C, N/R, SIN and T combination subject to licence; UBBC-07 and AO1125 also documented. Non-deposited house strain on enquiry
MicrobiologyGram-positive, obligately aerobic, endospore-forming rod. Facultative alkaliphile — grows in alkaline conditions most probiotic organisms will not tolerate
Resistance profileO/C, N/R, SIN and T are specified as poly-antibiotic-resistant. Genome analyses of A. clausii report AMR genes of low clinical relevance and no plasmids
Suspension presentation2 billion spores per 5 mL single-dose vial — the established commercial and clinical format. Capsule equivalent 2 x 10^9 CFU per unit
Bulk presentationDry spore concentrate powder; count to order. Preferred where transit conditions are uncertain or the buyer fills its own dosage form
AppearancePowder: off-white to cream, free-flowing. Suspension: slightly opalescent, colourless to pale liquid; spores sediment on standing, shake before use
Suspension vehicleSpores in purified water. Can be specified sugar-free, preservative-free and colour-free; flavour systems on request
Microbiological puritySalmonella, E. coli, S. aureus absent in the specified sample size; coliforms, yeasts and moulds within FSSAI limits for probiotic material
Heavy metalsLead, arsenic, cadmium and mercury within FSSAI and Codex limits; reported per lot
Allergen statusNot derived from milk, egg, fish, crustacean, peanut or tree nut. Request the lot-specific soy and cereal-gluten declaration for the fermentation medium
Origin and dietary statusMicrobial origin — not bovine, porcine or marine. Vegan and vegetarian suitable, non-GMO. Suspension is water-based with no animal-derived carrier
RegulatoryRecognised under FSSAI Schedule VII probiotic provisions; verify strain designation against the schedule in force. Registered as a medicinal product in some markets
Storage, shelf lifePowder 24 months, cool and dry. Suspension 24 months at 15–25 °C, upright, protected from light.
HS code3002.49 (30024910)
HS code3002.49 (30024910)
Bacillus clausii is an obligately aerobic, Gram-positive, endospore-forming rod and a facultative alkaliphile, growing in alkaline conditions that most probiotic organisms will not tolerate. Its name has moved twice: reclassified as Alkalihalobacillus clausii by Patel and Gupta in 2020 when the overcrowded genus Bacillus was split, and then transferred to Shouchella clausii by Joshi and colleagues in 2021. All three names describe the same organism, and buyers writing labels or dossiers for different markets should expect to see any of them in the source literature. The commercially established presentation is the ready-to-drink oral spore suspension: 2 billion spores in a 5 mL single-dose vial, the format used across the large clinical programmes conducted with the four-strain O/C, N/R, SIN and T combination. Those four strains are specified together precisely because of their poly-antibiotic resistance profile, a documented chromosomal characteristic of the combination; genome analyses of A. clausii report antimicrobial resistance genes of low clinical relevance and no plasmids, which points to a low risk of horizontal transfer. Other documented strains include UBBC-07 and AO1125. Thovek supplies bulk spore concentrate for customers formulating their own vials, sticks or capsules, and can arrange contract filling of the 5 mL suspension format. The suspension is an aqueous preparation of spores in purified water, and can be specified sugar-free and preservative-free. Because it is a liquid it is the least forgiving format in this range: it must be shipped upright, protected from light, held within the stated temperature window, and shaken before use since spores sediment on standing. The dry spore concentrate is far more robust and is the better choice where transit conditions are uncertain. The organism is grown on non-animal media, so both formats are vegan and vegetarian suitable and free of milk, egg, fish, crustacean and nut inputs; request the lot-specific soy and cereal-gluten declaration for the fermentation medium. Note that in several markets B. clausii oral suspension is registered as a medicinal product rather than a food supplement, which changes both the regulatory route and the tariff heading — tell us the destination market before we quote.

Applications

oral spore suspension vialssingle-dose stick packsprobiotic capsules and tabletspaediatric supplement formatsmulti-strain spore blendspharmacy channel private labelcontract filling and packing

Available grades

Ready-to-drink 5 mL oral spore suspension at 2 billion spores per vial, and dry spore concentrate powder at counts to order. Licensed four-strain O/C, N/R, SIN, T combination, single-strain UBBC-07, or non-deposited house strain. Sugar-free, preservative-free and flavoured suspension variants; contract filling of buyer-branded vials and stick packs available.

Packaging: Spore concentrate: 1 kg net in aluminium foil laminate pouches with desiccant, in HDPE drums of 5, 10 or 25 kg. Suspension: 5 mL amber or opaque glass vials, packed upright in printed cartons of 10, 20 or 30, shipper cases to order. Suspension must travel upright and within its stated temperature window; the dry concentrate ships ambient. Samples from 100 g powder or one carton of vials.

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