cGMP Facility • Texas
(844)-323-5628
Supplements Manufacturing

Probiotics & Microbiome Manufacturing

Lyophilized probiotic blend manufacturing with guaranteed CFU viability at time of expiry.

MNL produces probiotic dietary supplements in both powder and encapsulated formats using freeze-dried (lyophilized) probiotic strains from qualified suppliers. All probiotic batches are formulated with overages to guarantee the label-stated CFU (colony forming unit) count through the end of the product's shelf life. Cold storage and cold-chain handling protocols are maintained throughout production and warehousing.

Request a Production QuoteConsult Technical Team

Supported Dosage Forms & Formats

Probiotic Capsules (HPMC acid-resistant / delayed-release)Probiotic Powder Sachets (single-serve)Multi-Strain Probiotic Blends (up to 15 strains)Probiotic + Prebiotic Synbiotic FormulasSpore-Forming Probiotic Blends (Bacillus coagulans, subtilis)Probiotic Tubs (daily mix-in format)

Quick Fact Sheet

Key production parameters

Minimum Order Quantity

1,000 finished units

Standard Lead Time

5–8 weeks from strain qualification and PO

Cleanroom Standard

ISO Class 8 / 21 CFR Part 111 cGMP; dedicated probiotic fill room

Packaging Compatibility

  • HPMC Delayed-Release Capsules in HDPE Bottles
  • Foil-Lined HDPE Bottles (moisture barrier critical)
  • Aluminum Sealed Single-Serve Sachets
  • Probiotic Stick Packs (foil barrier, nitrogen-flushed)
  • Amber Glass Bottles (light-sensitive strains)

Mutual NDA Standard: All formula details, BOM data, and brand concepts shared during the quoting process are protected under a reciprocal Non-Disclosure Agreement executed before technical evaluation begins.

Laboratory Asset Pipeline

Machinery & Specimen Visual Verification

Inspect actual cleanroom machinery, finished dosage macro specimens, and packaging protocols dedicated to probiotics & microbiome manufacturing.

Finished nutritional supplement dosage forms lineup on white slab
Specimen Macro
21 CFR Part 111 cGMP Compliant | 100% Active Assay

Pharmaceutical-Grade Finished Dosage Specimen

Laboratory-developed formulation engineered for target bioavailability, organoleptic elegance, and shelf stability.

ISO 7 cleanroom environment with stainless steel machinery
Machinery Suite
ISO Class 7 Cleanroom | 25-30 Air Changes/Hour

Sanitary 316L Processing & Cleanroom Infrastructure

Positive-pressure cleanroom suites in Carrollton and Van Alstyne, TX with HEPA terminal filtration.

Analytical laboratory HPLC instrumentation and QC workstation
Analytical QA/QC
FTIR Dock Screening | Full COA Release Protocol

In-House Analytical Laboratory Testing & Verification

On-site HPLC potency testing, ICP-MS trace elemental detection, and USP microbiological verification.

Engineering Specification Table

ParameterSpecification / ValueNote
CFU Overage Strategy
Minimum 20% overage above label at time of manufacture to ensure viability at expiry
MNL SPEC
Strain Count Range
Single-strain to 15-strain custom blend
MNL SPEC
CFU Range (label)
1 billion – 100 billion CFU per serving
MNL SPEC
Strain Identity Confirmation
16S rRNA sequencing or species-specific qPCR
MNL SPEC
Viability Testing Method
Pour plate or spiral plating on selective agar (strain-specific)
MNL SPEC
Storage Conditions (production)
2°C – 8°C cold storage; fills conducted at ambient with minimal humidity exposure
MNL SPEC
Encapsulation Format
HPMC delayed-release capsules recommended for acid-sensitive strains
MNL SPEC
Cleanroom Classification
ISO Class 8 / 21 CFR Part 111 cGMP; probiotic fill room separate from allergen areas
MNL SPEC
Lead Time
5–8 weeks from strain qualification and PO
MNL SPEC

Specifications are representative of standard production parameters. Project-specific values may vary based on formula requirements, ingredient characteristics, and target packaging format. Contact our engineering team for exact specifications relevant to your batch.

Quality Assurance & Verification Protocol

Every probiotics & microbiome manufacturing batch passes through a four-phase analytical verification workflow before Certificate of Analysis issuance and release.

01

Probiotic Strain Qualification

Incoming probiotic raw materials confirmed for strain identity via 16S rRNA sequencing or species-specific PCR. COA from supplier confirms CFU count, moisture, and identity before use.

16S rRNA sequencing / species-specific qPCRSupplier COA CFU count verificationMoisture (LOD < 3.0%)Heavy metals (ICP-MS)
02

Manufacturing CFU Verification

Pre-encapsulation bulk powder CFU count assayed via pour plate on species-appropriate agar. Overage formula confirmed before filling begins.

Bulk powder CFU assay (pour plate method)Moisture check of bulk before fillEnvironmental monitoring of fill room (temp, RH)
03

Finished Product CFU & Viability

Finished encapsulated or packaged probiotic CFU count confirmed from retained samples. Stability pull samples enrolled in stability program to confirm CFU viability at expiration.

Finished-capsule CFU assay (pour plate)Moisture of finished capsuleMicrobial limits (yeast & mold, non-probiotic counts)Stability enrollment (real-time + accelerated)
04

COA Release

COA issued with CFU assay value, moisture, and strain identity reference. QA Director signs off. Cold-chain shipping documentation provided.

QA Director batch record sign-offCOA with CFU at manufacture, moisture, identityCold-chain shipping manifestClient COA transmittal

Certificate of Analysis (COA) — Issued Per Batch

Every commercial batch receives a QA Director–signed Certificate of Analysis on MNL letterhead. The COA documents all test parameters, analytical methods, results versus specification, and full lot traceability to raw material COAs. No batch ships without COA authorization.

Production Specification Request

Request a Quote for Probiotics & Microbiome Manufacturing

Submit your project brief through our structured multi-step quote engine. Pre-select Probiotics & Microbiome Manufacturing as your target manufacturing service. Our Carrollton, TX formulation and production team will provide a preliminary feasibility response within 24–48 business hours, under mutual NDA before any formula details are exchanged.

  • Preliminary quote returned within 24–48 business hours
  • Mutual NDA executed before formula review
  • Direct access to MNL formulation chemists
Request Quote for Probiotics & Microbiome Manufacturing

Or contact our engineering team directly

(844)-323-5628info@micellecosmeticslabs.com

Mon – Fri: 8:00 AM – 5:00 PM CST. Facility visits by advance appointment.

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