Primary service 01

Microneedle Development & Research Tools

Four modules covering research molds, formulation and process feasibility, characterisation, and skin delivery. Study design, problem diagnosis and interpretation are provided directly. Laboratory work is available by project, with study site, methods and responsible parties confirmed during feasibility review.

Discuss a microneedle project

01Molds & Masters
02Formulation & Process
03Characterisation
04Skin Delivery

Any module can be started on its own. Modules are also commonly combined.

Research Molds & Masters

Selection support for research molds and 3D-printed masters. LumiMicro helps translate the study goal into needle geometry, array format, material questions, a fabrication route and an acceptance plan.

Where this helps

You need a research mold but are not sure which specification fits—needle height, geometry, array density, material.
You have your own design and want the feasibility and precision boundaries assessed before committing.
You have a supplier specification sheet or quotation and want to confirm it matches the study purpose.
You are considering a 3D-printed master and need to assess printability, replication and dimensional risk.

What we provide

Provided directly

Mold selection guidance: matching specification to study purpose
Comparison of needle height, pitch, array count and mold or master route
Feasibility and precision-boundary discussion for custom masters
Process-route guidance for 3D-printed masters
Supplier specification review and enquiry checklists
Version control and incoming-acceptance planning

What you take away

The specification range your study purpose actually calls for
Whether a standard mold is sufficient, or custom work is justified
Which parameters on a specification sheet genuinely affect your result

Possible outputs

Specification recommendation · Selection comparison table · 3D-print feasibility brief · Supplier enquiry checklist · Incoming-acceptance check template

What to send first

Study purpose and the question to be answered · API or matrix class (non-confidential level) · Target needle-height range and array size · Standard mold or custom master interest · Quantity and timing expectations · Destination country or region. Share confidential CAD only after a separate channel is agreed.

Three starting points for mold selection

These are examples for comparing research specifications, not a product list, stock statement or performance claim. Final geometry and material are defined against the study question.

Reference route	Nominal needle height	Array / pitch	What to decide
Short, dense array	400 µm	20 × 20 / 500 µm	Does a higher needle count suit the planned casting, demoulding and inspection workflow?
Mid-range array	800 µm	15 × 15 / 800 µm	How should geometry and array area be balanced with formulation and handling constraints?
Longer, lower-count array	950 µm	10 × 10 / 800 µm	What mechanical and insertion evidence is needed before this geometry can be justified?

For non-standard geometries, a 3D-printed master may be assessed for design ownership, printability, material and post-processing, replication route and dimensional inspection. Fabrication and the executing party are confirmed per project.

Scope. For institutional or company non-clinical research and prototype development only. Not supplied as a medical device and not for human use. LumiMicro currently provides specification and selection support; mold supply and quotation are not offered. Custom designs must be owned or properly authorised by the customer.

Formulation & Process Feasibility

Research-scale formulation and process work for dissolving and related microneedle concepts. Study design and problem diagnosis are provided directly; laboratory work is available by project, with study site and responsible parties confirmed during feasibility review.

Where this helps

You are considering a dissolving microneedle but are unsure how to select the matrix system.
You have a formulation that does not form well—bubbles, demoulding damage, incomplete tips.
You want to know whether your API can be carried in a microneedle, and at what loading.
You want small-scale feasibility evidence before committing to a larger development programme.

What we provide

Provided directly

Screening study design for candidate matrix systems
Root-cause analysis and improvement direction for forming problems—bubbles, casting and filling, drying, demoulding, backing formation
Development-route and stage-definition guidance

Available by project

Formulation and process screening
Research-scale prototype preparation
Initial appearance, handling and stability questions

What you take away

Whether this API and matrix combination is feasible in a microneedle format
Whether a forming problem originates in the formulation or the process
The approximate order of magnitude for loading
Whether a further development stage is justified

Possible outputs

Formulation and process screening matrix · Research-scale prototypes (quantity defined per project) · Prototype preparation summary · Feasibility or study plan · Recommended next development step

What to send first

Non-confidential product goal and development stage · API class or matrix type (non-confidential level) · What has been tried and what was observed · Samples, where required, through an agreed route

Scope. Research-scale work. Does not represent a validated manufacturing process and does not constitute GMP production or clinical supply. No certainty of outcome is implied. Study site, personnel, methods and responsible parties are confirmed item by item during feasibility review.

Characterisation & Performance

Scope-defined evaluation of the physical and functional attributes that matter to an early microneedle decision. Study design and interpretation are provided directly; measurement work is available by project through the confirmed delivery arrangement.

Where this helps

You have a batch of microneedle samples and need to know the forming quality.
You need evidence that the needles insert into skin, and to what depth.
You need to understand how the needles dissolve in skin and what residual height remains.
You need objective characterisation data for an investor or internal decision.
You want a baseline before commissioning a CRO.

What we provide

Provided directly

Characterisation study design and endpoint selection
Interpretation of data and technical reports, including stated limitations

Available by project

Morphology and array-integrity observation
Dimensional measurement and microscopic assessment
Mechanical response (compression / fracture)
Ex vivo skin insertion assessment
Intradermal dissolution and residual-height assessment
Content, loading or initial stability questions, where feasible

What you take away

Whether forming quality is sufficient to proceed to the next step
Whether mechanical strength supports insertion into the target skin model
Whether dissolution behaviour supports the intended delivery concept
How consistent the batch is
Which parameters still need data before a conclusion can be drawn

Possible outputs

Characterisation data tables and figures · Microscopy images · Observation records · Technical report stating method, model and limitations · Recommended next step

What to send first

Samples, with quantity, packaging and storage conditions as agreed · Non-confidential sample background: type, intended needle height, matrix class · The specific question to be answered · Existing data, if any

What insertion and dissolution assessment measure. Comparing the two states gives insertion depth and residual height — the basis for judging whether forming quality and mechanical strength support the intended delivery concept. Schematic only — not to scale, and not a depiction of any specific sample or result.

Scope. In vitro and ex vivo results hold only within the stated specification, method and model. They do not by themselves establish human performance, safety, clinical benefit, regulatory acceptance or manufacturing readiness. Pig-ear skin is used for in vitro research by project only and is not human-derived, clinical, or supplied as a sterile material by default. Study site, personnel and responsible parties are confirmed per project.

Skin Delivery Evaluation

Microneedle-related skin delivery questions: permeation, retention and distribution. Study planning, endpoint selection and report interpretation are provided directly; study work is available by project.

Where this helps

You want to know how much drug the microneedle actually delivered into or through skin.
You want to compare delivery with and without microneedle application.
You want to understand distribution across skin layers.
You are preparing to commission IVPT work and want the study design reviewed.
You have received a CRO report and want it interpreted or challenged.

What we provide

Provided directly

IVPT feasibility assessment and study design
Model, sampling approach and endpoint selection guidance
External laboratory and CRO enquiry checklists
Protocol and report review and interpretation

Available by project

Microneedle-assisted permeation studies
Skin retention and distribution studies
Sample processing and delivery for customer-run analysis—surface wash, tape stripping, epidermis/dermis separation, sectioning, labelling, packaging, storage and handover

What you take away

Whether the microneedle produced a delivery gain, and of what magnitude
Which skin layer the compound predominantly resides in
Whether a CRO protocol contains design weaknesses
How far a report's conclusions can be relied on, and what they do not support
What evidence to add next

Possible outputs

Receptor fluid samples · Endpoint membranes · Unextracted baseline skin samples · Processed separated samples with labelling, packaging, storage and handover records · Data tables and observation records · Study protocol · Report interpretation note

What to send first

Samples and non-confidential background · Target API and intended delivery site · Existing data or CRO report, where interpretation is needed · Your analytical situation—whether analysis is run in-house or needs to be coordinated

Looking for IVRT or IVPT support outside a microneedle context? See IVRT & IVPT Support.

Scope. Human skin is not provided or displayed. Pig-ear skin and IVRT membranes are handled by project enquiry for in vitro research use only. No inventory, fixed channel, in-house laboratory, equipment ownership or distribution authorisation is implied. Not GLP/GMP, clinical, or registration-purpose work. The analytical route and executing party are confirmed per project.

Start with a non-confidential question.

Tell us which module or combination you are considering, what stage the work is at, and what the next decision needs to be. Availability, methods, study site and responsible parties are confirmed before scope is agreed.

Discuss a microneedle project