Manufacturing
Production-Ready at Scale
Dakota operates a 35,000-square-foot FDA-registered manufacturing facility with ISO 22716 and WHO GMP certifications -- purpose-built for probiotic formulation, compounding, and filling at commercial volumes.
FDA-registered manufacturing facility
Good Manufacturing Practice for cosmetics
World Health Organization manufacturing standards
U.S. Food and Drug Administration registered facility
Compounding
Precision Formulation at Volume
Dakota's compounding department operates 316L stainless steel tanks ranging from 60 to 1,000 gallons, enabling batch sizes from development-scale prototypes to full commercial production runs. Every batch follows documented SOPs with in-process quality checks, ensuring the encapsulated probiotics maintain viability throughout the compounding process.
- 316L stainless steel tanks (60-1,000 gallon capacity)
- Development-scale through commercial production volumes
- Documented SOPs with in-process quality verification
- Temperature-controlled compounding for probiotic viability
Filling Operations
Four Semi-Automated Filling Lines
The filling department operates four semi-automated filling lines capable of processing 7,500 to 25,920 units per shift depending on format and container size. Lines are configured for multiple container types and can be switched between formats with minimal downtime, supporting both dedicated production runs and multi-SKU manufacturing programs.
Fill Capabilities
Multiple Container Formats
Tubes
Squeeze tubes in multiple sizes for creams, gels, and topical formulations.
Jars
Wide-mouth jars for thick creams, masks, and treatment products.
Bottles
Pump bottles, flip-tops, and droppers for liquid and serum formats.
Closures
Custom closure options including pumps, caps, sprayers, and dropper assemblies.
Infrastructure
End-to-End Manufacturing Support
Quality Control Lab
On-site QC laboratory for raw material testing, in-process checks, stability studies, and finished product release testing.
R&D Laboratory
Dedicated research and development lab for formulation optimization, new product development, and scale-up testing.
Vendor Relationships
Established supply chain partnerships for raw materials, packaging components, and specialty ingredients with qualified vendor qualification programs.
Discuss Your Manufacturing Needs
From development batches to full-scale production, our team is ready to scope your project and provide a manufacturing pathway.
Request a Consultation