cGMP Facility • Texas
R&D & Value-Added Services

Custom Blending & Formulation Services

Contract blending and private-label formulation from concept brief to production-ready master formula.

MNL's R&D and custom blending service supports brands from initial concept through finalized, production-ready master formula. Whether you have a complete Bill of Materials ready for scale-up or a concept brief that needs chemist-guided formulation, our team delivers stability-aware formula design, ingredient sourcing advisory, and regulatory review before production initiation. All custom formulations developed under mutual NDA.

Supported Dosage Forms & Formats

Custom Powder Blend Formulation (all categories)Custom Capsule Fill Formula DevelopmentCustom Tablet Formula Design (direct compression + wet gran)Custom Liquid Formula DevelopmentTech Transfer & Scale-Up from Pilot to CommercialExisting Formula Reformulation (cost optimization, ingredient swap)Private Label Formula Licensing (MNL stock formulas)

Quick Fact Sheet

Key production parameters

Minimum Order Quantity

R&D service — formulation fees apply; production MOQ applies at scale-up

Standard Lead Time

6–14 weeks depending on formulation complexity and iteration cycles

Cleanroom Standard

R&D lab + 21 CFR Part 111 compliant production scale-up

Packaging Compatibility

  • Applicable to all MNL manufacturing lines upon scale-up to production

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 custom blending & formulation services.

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
Formulation Scope
All dietary supplement categories under DSHEA 1994
MNL SPEC
R&D Pilot Batch Size
1 – 10 kg bench; 25 – 100 kg pilot blender
MNL SPEC
Stability Protocol
Accelerated (40°C/75% RH) and real-time (25°C/60% RH) available
MNL SPEC
IP Protection
Mutual NDA executed before formula sharing; all IP remains client property
MNL SPEC
Regulatory Review
Preliminary DSHEA and 21 CFR Part 101/111 label compliance review included
MNL SPEC
Sourcing Advisory
Branded ingredient (KSM-66®, Creapure®, etc.) procurement guidance included
MNL SPEC
Formula Deliverable
Master Formula Record (MFR) with BOM, process instructions, and spec limits
MNL SPEC
Engagement Lead Time
Formulation engagement begins within 5 business days of signed NDA and deposit
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 custom blending & formulation services batch passes through a four-phase analytical verification workflow before Certificate of Analysis issuance and release.

01

Concept & Ingredient Feasibility Review

R&D team reviews the concept brief, target label claims, ingredient interactions, and regulatory constraints before formulation begins. Incompatible ingredient combinations and label claim risks identified at intake.

Ingredient interaction reviewDSHEA label claim feasibility assessmentRegulatory risk identification (new dietary ingredient status)Ingredient sourcing landscape review
02

Bench-Scale Prototype Development

Bench formulation in 1–10 kg quantities. Multiple iterations evaluated for blend homogeneity, flow properties, and sensory characteristics before pilot scale-up approval.

Bench prototype blending (1–10 kg)BU check on bench prototypeSensory evaluation panelPhysical property assessment (flow, density, moisture)
03

Pilot Batch Validation

Scale-up to 25–100 kg pilot batch. BU, physical, and potency testing on pilot batch. Pilot batch serves as basis for stability enrollment and production scale validation.

25–100 kg pilot batch productionFull BU and potency testingStability enrollment (pilot batch)Manufacturing process parameter documentation
04

Master Formula Record Delivery

Finalized Master Formula Record (MFR) with BOM, raw material specifications, process instructions, in-process limits, and finished product specification delivered to client for production authorization.

Complete MFR documentationRaw material specifications and COA requirementsIn-process and finished product specification limitsClient formula approval and production sign-off

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 Custom Blending & Formulation Services

Submit your project brief through our structured multi-step quote engine. Pre-select Custom Blending & Formulation Services 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 Custom Blending & Formulation Services

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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