Description
Bifidobacterium breve is a dominant native species in the infant gut microbiome, particularly in breastfed infants, and is highly specialized for human milk oligosaccharide utilization. The species is widely used in infant and pediatric probiotic formulations.
Supplied as a freeze-dried powder with viability between 100 and 500 billion CFU per gram at release. The species is moderately oxygen-sensitive and requires careful manufacture and packaging to maintain viability through shelf life.
Off-white to pale beige free-flowing powder with a faintly fermented note. Particle size suitable for infant drops, pediatric sachets, capsule filling, and infant formula fortification.
We supply food-grade Bifidobacterium breve from manufacturers in China holding ISO 22000, FSSC 22000, Halal, Kosher, and other certifications relevant to probiotic strain production.
Common market grades include 100, 200, and 500 billion CFU per gram freeze-dried powders, microencapsulated grades for oxygen and acid protection, oil-suspension formats for infant drops, and infant-formula-qualified grades meeting elevated bioburden and contaminant criteria. Bulk and reduced-MOQ shipments with batch-level COA covering viable count, strain identity, moisture, heavy metals, and pathogen panel.
Introduction
Bifidobacterium breve was originally isolated from infant feces and described by Reuter in 1963. The commercial strain M-16V developed by Morinaga Milk Industry is one of the most clinically studied infant probiotic strains in the world, with extensive evidence in pediatric and neonatal care.
Industrial production proceeds under strict anaerobic conditions in cysteine-supplemented semi-defined media optimized for Bifidobacterium metabolism. Biomass is harvested under nitrogen blanket, cryoprotected with trehalose, sucrose, or skim milk, and lyophilized to residual moisture below 4 percent.
Regulatory status includes GRAS notifications with FDA for specific strains, Qualified Presumption of Safety listing in the European Union, and approval for inclusion in infant formula in Japan, the European Union, and other major regulatory regions.
Clinical evidence supports B. breve M-16V in atopic dermatitis prevention in at-risk infants, reduction of necrotizing enterocolitis incidence in preterm infants when combined with B. infantis, and overall gut microbiome development in pediatric populations.
Where it is used
- Infant formula fortification and follow-on formula applications
- Pediatric probiotic drops, sachets, and powders
- Allergy prevention and atopic dermatitis support in infants
- Adult capsules for gut microbiome restoration
- Functional fermented dairy and probiotic shots
- Necrotizing enterocolitis prevention in preterm infants (clinical context)
- Multi-strain pediatric probiotic stacks
- Synbiotic formulations with GOS and HMO prebiotics
- Postbiotic and tyndallized cell pediatric applications
Technical data
| Item | Specification |
|---|---|
| Appearance | Off-white to pale beige free-flowing powder |
| Viable cell count | ≥ 150 billion CFU/g (100B, 200B, 500B grades) |
| Strain identity | Confirmed by 16S rRNA sequencing and species-specific PCR |
| Moisture (loss on drying) | ≤ 4.0% |
| Particle size | ≥ 95% through 80 mesh |
| Heavy metals (as Pb) | ≤ 1 mg/kg |
| Arsenic | ≤ 0.5 mg/kg |
| Salmonella | Absent in 25 g |
| E. coli | Absent in 10 g |
| Staphylococcus aureus | Absent in 10 g |
| Yeast and mold | ≤ 50 CFU/g |
| Shelf life | 18 to 24 months from manufacture under recommended storage |
| Storage | −18 °C sealed; 2 to 8 °C after opening |
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