What Dakota Biotech does

Dakota Biotech is a private biotechnology company that has developed a proprietary phospholipid bilayer vesicle encapsulation platform for delivering live, metabolically active probiotics without refrigeration. The technology wraps probiotic strains in concentric phospholipid bilayers modeled on human cell membranes, achieving >90% viability at 25°C, >80% at 40°C, and a 36-month room-temperature shelf life, with triggered release at 33°C skin temperature. The Sarasota, Florida-based company has been operating since 2014 and runs a 35,000-square-foot FDA-registered manufacturing facility holding ISO 22716 and WHO GMP certifications, equipped with four semi-automated filling lines and compounding capacity of 60–1,000 gallons. All phospholipid excipients carry FDA-GRAS designation, and the platform is protected by issued and pending patents.

The company operates an exclusively B2B model with four engagement types: contract manufacturing, white-label formulations, co-development partnerships, and technology licensing. Pricing is quote-based and tailored to project complexity, formulation requirements, and regulatory pathway. Target customers are brand owners, contract manufacturers, formulators, and researchers across six application areas: dermatology and skincare (primary), hair and scalp care, women's health, oral and gut health, medical devices, and agricultural/environmental applications. Go-to-market is direct enterprise engagement through website inquiry forms, scientific and industry positioning, and partner referrals, with a stated global geographic reach.

Clinical substantiation is generated through a core partnership with Sequential Bio, an independent research organization running studies across acne, eczema, psoriasis, rosacea, sun-exposure recovery, bacterial vaginosis, and vulvovaginal candidiasis, with completion targeted by October 2026. Reported outcomes include 100% dermatitis symptom reduction at 14 days, 50% acne symptom reduction, 25% increase in skin hydration, 25% reduction in inflammation signs, and strengthened post-procedure skin barrier. The company holds CCPA- and GDPR-aligned privacy practices, has 11–50 employees, and is privately held with no disclosed funding history, revenue figures, or institutional investors.

Name

Dakota Biotech

Legal name

Dakota Biotech

Website

https://dakotabiotech.com

Company type

Private

Founded year

2014

Operating status

Operating

Headcount range

11–50 employees

Short description

Dakota Biotech is a private biotechnology company that has developed a proprietary phospholipid bilayer encapsulation platform enabling shelf-stable, live probiotic delivery without refrigeration, serving B2B brand, manufacturer, and research partners across skincare, personal care, women's health, oral, medical device, and agricultural applications.

Ownership category

akta.pro rank

Product category

Probiotic Biotechnology Manufacturing

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Pharmaceutical Preparation Manufacturing (325412), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Biological Products, (No Disgnostic Substances) (2836), Pharmaceutical Preparations (2834), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Microbiome Manufacturing, Formulation & Delivery Technologies (encapsulation, spores, oral delivery) (HLAAAFAJ)

akta.pro secondary industries

Delivery Systems & Encapsulation (Microencapsulation, Liposomes, Emulsions, Beadlets, Spray-Dried) (AFAJAKAL), Probiotics (Strains, Spore-Formers, Synbiotic Components) (AFAJAKAE), Process Development & Tech Transfer Services (upstream/downstream) (HLAAAKAF)

Keywords

• Probiotic encapsulation
• Live probiotic delivery
• Contract manufacturing
• Skincare biotechnology
• Technology licensing

Headquarters

HQ city

Sarasota

HQ country

United States

HQ region

North America

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Technology or R&D, Operations, Infrastructure, Marketing or Sales

Revenue model

1. Contract Manufacturing: FDA-registered manufacturing services from a 35,000-square-foot facility with ISO 22716 and WHO GMP certifications. Operates four semi-automated filling lines processing 7,500 to 25,920 units per shift, with compounding capabilities from 60 to 1,000 gallon batch sizes.
2. White-Label Formulations: Pre-formulated probiotic product offerings available for branding and distribution by partners, leveraging Dakota's encapsulation technology and manufacturing capabilities.
3. Co-Development Partnerships: End-to-end formulation co-development services working alongside partner R&D teams to engineer custom probiotic products from strain selection through production-ready formulations.
4. Technology Licensing: Licensing of proprietary encapsulation technology, formulation methods, and application processes to partners seeking access to defended probiotic delivery platform.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels3 records

Core offering

Dakota Biotech provides a phospholipid bilayer vesicle encapsulation platform that keeps live probiotics shelf-stable and metabolically active at room temperature for up to 36 months without refrigeration. Built on this core platform, the company sells Contract Manufacturing Services from an FDA-registered, ISO 22716 and WHO GMP-certified 35,000-square-foot facility, Co-Development and Custom Probiotic Formulation Services spanning cosmetic, OTC, prescription, and medical device categories, and White-Label Formulations ready for partner branding across skin, scalp, body, vaginal, oral, and medical device applications.

Product overview

Dakota Biotech offers a unified platform centered on its proprietary phospholipid bilayer encapsulation technology for delivering shelf-stable live probiotics. The portfolio consists of the Live Probiotic Encapsulation Platform as the core technology, supplemented by Contract Manufacturing Services (FDA-registered facility with ISO 22716 and WHO GMP certifications for compounding and filling), and Co-Development/Custom Probiotic Formulation Services for custom strain selection and regulatory guidance. White-label formulations are available for partners seeking ready-to-market products. The platform serves dermatological applications initially, with expansion into gut health, oral care, agricultural biosolutions, and environmental remediation.

Differentiator

Problem solved

Functional benefit

Products and services

• Live Probiotic Encapsulation Platform Proprietary phospholipid bilayer vesicle technology that encapsulates live probiotics, keeping them shelf-stable and metabolically active at room temperature for up to 36 months without refrigeration; the vesicles release viable probiotics upon skin contact through triggered fusion with skin membranes, available to brand partners for licensing.
• Contract Manufacturing Services FDA-registered manufacturing services operating from a 35,000-square-foot facility with ISO 22716 and WHO GMP certifications, providing probiotic formulation, compounding (60 to 1,000 gallon batch sizes in 316L stainless steel tanks), and commercial-scale filling across four semi-automated lines processing 7,500 to 25,920 units per shift, for brand partners seeking commercial probiotic production capacity.
• Co-Development and Custom Probiotic Formulation Services End-to-end formulation co-development partnering with brand R&D teams to engineer custom probiotic products, including strain selection, formulation optimization, stability testing, and regulatory pathway guidance across cosmetic, OTC, prescription, and medical device categories.
• White-Label Probiotic Formulations Ready-to-market probiotic product formulations available for licensing or white-label partnership, covering face and skin, hair and scalp, body care, vaginal health, oral health, and medical device applications, leveraging Dakota's encapsulation technology and manufacturing capabilities.

Quantifiable outcome

• 100% reduction in dermatitis symptoms after 14 days of topical live probiotic treatment (dermatologist score from 1.0 to 0)
• +6 more outcomes

Segments6 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

One partnership is on record.

• Sequential BiocoreStrategic or Co-development PartnerSequential Bio is a clinical research partner that independently conducts and validates clinical studies for Dakota Biotech's probiotic encapsulation technology. Studies include investigations for acne, eczema, psoriasis, rosacea, sun exposure recovery, bacterial vaginosis, and vulvovaginal candidiasis, all independently performed and on track for completion by October 2026.

Scale indicators6 records

Recent moves5 records

Expansion highlights4 records

Broad incumbents

• Catalent: Major pharmaceutical and consumer health CDMO offering formulation, encapsulation, and fill-finish services. Compares on the contract manufacturing and softgel/encapsulation side.
• Lonza Group: Global CDMO with encapsulation and biologics manufacturing across pharma, nutrition, and personal care. Comparable as a regulated contract manufacturer and technology licensor operating at much greater scale.
• ADM (Biopolis/Protexin): Global ingredient conglomerate with a probiotics and microbiome business serving nutrition, food, and personal care. Comparable as a large-scale probiotic ingredients and biotics platform.
• Royal DSM-Firmenich (i-Health): Science-based ingredient company with biotics and nutritional lipid platforms serving personal care and nutrition customers. Comparable as a diversified ingredient supplier with microbiome-adjacent IP.

Emerging players

• Codex Beauty Labs: Probiotic skincare brand using live-fermented and biotic ingredients. Comparable as a brand-side consumer of probiotic delivery technology rather than as a CDMO.
• AOBiome (Mother Dirt): Live-bacteria focused skincare company applying live microbial cultures to topical products. Adjacent comparable working at the consumer brand end of the same live-probiotic skincare thesis.

Direct peers

• Novonesis (formerly Chr. Hansen): Leading microbial and fermentation company producing probiotic strains and bioprotective cultures for food, supplement, and personal care. Comparable as a probiotic ingredient and platform supplier for consumer brands.
• Lallemand Health Solutions: Probiotic manufacturer producing strain-specific formulations for human health, nutrition, and skin applications. Comparable as a probiotic ingredient supplier targeting similar indication areas including dermatology.
• Kerry Group (Ganeden): Global taste and nutrition company with a Ganeden-branded probiotic ingredient business serving food, beverage, and personal care. Comparable as a probiotic strain supplier with branded ingredient offerings.
• Probi AB: Specialist probiotic ingredient company offering proprietary strains and delivery formats to consumer health brands. Comparable in business model, target customers, and probiotic IP focus.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/dakota-biotech

Compliance6 records

Revenue estimate

Valuation estimate

Number of profiles

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Dakota Biotech