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The One Pot Process (OPP) Method is a patent-pending cold-process, single-vessel co-formulation technique developed by GlowSense Pty Ltd (Patent Application AU 2026901796, filed 5 March 2026, GlowSense Holdings Pty Ltd). All ingredients — including target actives and marine bio-spicules from Haliclona sp. — are combined simultaneously in a single vessel at ambient temperature. No heating phase is required at any stage of manufacture.

On topical skin application, the siliceous spicules (~120 µm length, ~7 µm diameter) create transient microchannels in the stratum corneum, enabling sub-epidermal delivery of co-formulated actives at 33–91× conventional penetration levels.

A global prior art search across AU, US, EP, CN, KR and WO jurisdictions confirmed zero prior art for this specific cold-process bio-spicule co-formulation method.

While marine bio-spicule transdermal delivery has been published in peer-reviewed literature (Zhang et al., 2017), the specific cold-process single-vessel co-formulation method — combining spicules and actives simultaneously at ambient temperature as a manufacturing process — had no prior art in any of the six jurisdictions searched (AU, US, EP, CN, KR, WO).

Prior published work described spicule application as a separate topical step after formulation, not as a co-formulated manufacturing process. The OPP innovation is the manufacturing method itself — how spicules are incorporated into the formulation at the point of manufacture, at ambient temperature, in a single vessel.

The OPP Method's bio-spicule delivery was directly compared to Dermaroller microneedling in peer-reviewed research. OPP bio-spicules achieved 15.39 ± 9.91-fold superior in vivo enhancement compared to Dermaroller (p < 0.05) in BALB/c mice.

• OPP: Topical application only — no device, no clinic, no pain, self-limiting disruption
• Microneedling: Requires a device and practitioner, potential discomfort
• OPP: Co-formulated actives are delivered with spicule application simultaneously
• OPP: Spicules retained 72 hours as sustained-release depots in skin
• OPP: Skin fully recovers — TEWL returns to baseline (confirmed in vivo)

Cold-process cosmetic manufacturing combines all ingredients at ambient temperature (~20–25°C), without a separate heating phase. Conventional cosmetic emulsification requires heating to 70–75°C to melt waxes and create a stable emulsion. Cold-process uses self-emulsifying polymers (Aristoflex AVC, carbomers, BTMS-based systems) that form stable emulsions at room temperature.

The key benefit is complete preservation of heat-sensitive actives — peptides, retinol, vitamin C derivatives, enzymatic actives and growth factors — that are irreversibly denatured or degraded during conventional hot-process manufacture.

Published peer-reviewed data confirms 40–100% retinoid decline at 40°C in accelerated stability testing. Temova Rakuša et al. (2020) conducted HPLC-UV analysis of 16 retinoid derivatives in 12 commercial cosmetics over 6 months at both 25°C and 40°C. Retinoid degradation followed first-order kinetics, with thermal isomerisation of biologically active all-trans-retinol to inactive cis-retinol confirmed at elevated temperatures.

At standard emulsification temperature of 70–75°C, retinol degradation is substantially or completely complete before the product is ever filled. Cold-process manufacture eliminates all thermal exposure.

Cosmetic peptides — signal peptides, matrikines, copper peptides and neurotransmitter-inhibiting peptides — begin to denature as heat disrupts the non-covalent interactions (hydrogen bonds, hydrophobic interactions) that maintain their functional tertiary structure.

• GHK-Cu (Copper Tripeptide-1): Must never exceed 40°C — thermal degradation confirmed, copper disassociates from peptide bond under heat
• Matrixyl 3000® (Palmitoyl Peptide Complex): Heat-labile above 45–50°C
• Capixyl™ (Biotinoyl Tripeptide-1): Heat-labile above 45°C
• Argireline® (Acetyl Hexapeptide-3): Heat-labile above 40–45°C

At emulsification temperatures of 70–75°C, all of these peptides are substantially or completely denatured. Cold-process manufacture is the only viable option for any cosmetic making credible peptide efficacy claims at therapeutic concentrations.

Yes — but with important distinctions by type:

Live probiotic cultures (Lactobacillus rhamnosus, L. reuteri, Bifidobacterium longum) are killed above 37°C and are completely incompatible with any hot-process manufacturing. Cold-process low-water formulations are the only viable route for genuinely live probiotic cosmetics.

Postbiotic ferment lysates (Bifida Ferment Lysate, Lactobacillus Ferment Lysate) are more heat-stable than live cultures, as they are already inactivated during production. Published research (PMC10572142) confirmed antioxidant and anti-inflammatory activity of postbiotics remained unaffected below 100°C. However, specific enzymatic bioactivities within ferment lysates — sphingomyelinase, antimicrobial peptides, SCFA production — are sensitive to emulsification temperatures (65–95°C range causes measurable enzyme inactivation per PMC12639491). Cold-process co-formulation preserves the complete enzymatic and bioactive profile.

Prebiotics (inulin, FOS oligosaccharides) undergo caramelisation and chain degradation under sustained heat, reducing prebiotic selectivity for beneficial skin microbiome strains.

Astaxanthin is a thermolabile marine carotenoid. Published research confirms its degradation rate increases significantly with temperature, following first-order kinetics:

• Rate constant increases progressively from 4°C through 60°C (Springer, 2016)
• Significant degradation above 60°C — degradation rates above 20% confirmed at high temperatures (PMC11582459, 2024)
• All-trans isomer decreases >50% at 80°C after 16 hours (Antioxidants, 2020)

At standard emulsification temperatures of 70–75°C, astaxanthin undergoes substantial thermal degradation and isomerisation, significantly reducing its antioxidant activity. Cold-process manufacture prevents all thermal degradation from the manufacturing process.

No. Enzymatic actives including Superoxide Dismutase (SOD), Catalase, and DNA repair enzymes (Photolyase, T4 Endonuclease V) are proteins whose biological activity depends entirely on their intact tertiary structure. Protein denaturation — the irreversible unfolding of this structure — occurs when heat disrupts the non-covalent interactions maintaining it.

For SOD and Catalase, enzymatic activity is lost at temperatures above 40°C. DNA repair enzymes (photolyase from bacteria and algae) are similarly heat-labile proteins. At conventional emulsification temperatures of 70–75°C, all enzymatic activity is completely and irreversibly destroyed.

Cold-process OPP manufacture is the only viable manufacturing route for any cosmetic making credible claims about active SOD, Catalase or DNA repair enzyme delivery.

Haliclona sp. spicules are siliceous (silicon dioxide) oxea-type structures approximately 120 µm length, 7 µm diameter. When massaged onto skin, their oscillatory motion creates transient microchannels in the stratum corneum for sub-epidermal delivery of co-applied actives. Disruption is dose-dependent and self-limiting — skin fully recovers (TEWL confirmed). Spicules retained for 72+ hours act as sustained-release depots.

• 33.09 ± 7.16× — in vitro porcine skin penetration enhancement (p < 0.01)
• 62.32 ± 13.48× — dermis accumulation vs passive control (p < 0.01)
• 72.14 ± 48.75× — in vivo BALB/c mice enhancement (p < 0.05)
• 15.39× — superior to Dermaroller microneedling in vivo (p < 0.05)
• 73.4% — human dermal absorption rate (clinical trial, 2025)

Yes. Published safety data confirms Haliclona sp. spicules are biocompatible and safe for topical cosmetic use:

• Skin disruption is self-limiting and fully recoverable — TEWL returns to baseline (Zhang et al., 2017, guinea pig skin in vivo)
• No systemic toxicity observed in animal studies
• Composed of silica (silicon dioxide) — biologically inert material
• 2025 human clinical trial (PMC12564063) confirmed safe topical application with no adverse events

GlowSense requires spicule purity of ≥90% for topical-grade cosmetic applications, verified at receipt and before production use.

The stratum corneum is a ~10–20 µm thick layer of dead keratinocytes in a lipid matrix. It blocks most cosmetic actives from reaching the viable epidermis and dermis where they can exert their effects:

• Hydrophilic molecules (peptides, vitamin C) are blocked by the lipid-rich barrier
• The 500-Dalton rule — molecules above ~500 Da generally cannot passively penetrate
• Growth factors, collagen peptides, postbiotic complexes all exceed this size limit
• 10 kDa fluorescent dextran (used in OPP research) is 20× larger than the passive penetration threshold

OPP bio-spicule microchannels bypass this barrier, enabling sub-epidermal delivery of actives regardless of size or hydrophilicity — directly solving the fundamental penetration limitation of topical cosmetics.

ISO 22716:2007 is the international standard for cosmetic Good Manufacturing Practices (GMP), covering production, quality control, storage and shipment. It is the globally accepted framework required for:

• EU cosmetic export under EC No. 1223/2009 (Cosmetics Regulation)
• UK market entry documentation post-Brexit
• TGA cosmetic compliance documentation in Australia
• FDA cosmetic GMP alignment in the United States
• Asian market export certification (DAFF Certificate of GMP Compliance)

GlowSense Pty Ltd holds ISO 22716 GMP certification, independently audited by SGS Australia (one of the world's leading certification bodies), with annual surveillance audits maintaining ongoing certification.

A Certificate of Analysis (CoA) is a GMP-required document issued for each production batch confirming the product meets all release specifications. It records:

• pH — measured and within specification
• Viscosity — measured and within specification
• Appearance, colour and odour — as per specification
• Microbial limits — total viable count, yeast, mould, pathogens
• Batch number and manufacturing date
• Authorised signatory release

GlowSense issues a GMP-compliant CoA for every production batch. For OPP Method batches, CoA additionally includes spicule distribution uniformity verification. The CoA is required documentation for brand-side regulatory submissions and retail buyer onboarding.

GlowSense minimum order quantities:

• Custom formulation development pilot batch: 50 kg
• White label (existing GlowSense formulation): 500 units per SKU
• Contract manufacturing (ODM/OEM): 500 units minimum
• OPP Method manufacturing: 500 units minimum

Volume pricing available above 2,000 units. All manufacturing at 114 Eucumbene Drive, Ravenhall VIC 3023, Melbourne, Australia.

Typical timelines from brief to shelf-ready product:

• White label (existing formulation): 4–8 weeks
• Custom formulation + production: 10–16 weeks
• OPP Method custom formulation: 12–16 weeks (includes spicule compatibility testing)
• Stability testing for shelf-life claims: Additional 3–12 months (accelerated or real-time)

Timeline depends on formulation complexity, active ingredient sourcing and regulatory documentation requirements for your target market. Contact us with your brief for a specific estimate.

Yes. GlowSense signs a Non-Disclosure Agreement (NDA) before any technical brief discussion. Your formulation, active ingredient selection, target concentrations and product positioning are your intellectual property. We do not share, use or reference client briefs outside the scope of your specific manufacturing engagement.

GlowSense operates exclusively as a contract manufacturer and does not compete in the retail market using client formulations. Our own consumer brand (GlowSense DTC) uses only GlowSense-owned formulations.