Pharmaceutical Companies
Develop differentiated dosage forms, lifecycle-management products and alternative delivery pathways.
MICRONEEDLE DRUG-PRODUCT DEVELOPMENT
Microneedle Drug Delivery CRO/CDMO
Integrated development support for pharmaceutical and biotechnology companies—from payload assessment and prototype formulation to process scale-up and manufacturing.FEASIBILITY FIRST
Can Your Drug Candidate Become a Microneedle Product?
Developing a microneedle drug product requires more than selecting a patch format. Payload properties, target dose, formulation stability, microneedle structure, skin-delivery performance, analytical methods and manufacturing scalability must be considered as one system.
CASMN works with pharmaceutical and biotechnology partners to evaluate these factors and define a stage-appropriate development pathway.
WHO WE WORK WITH
Programs at Different Development Stages
Biotechnology Companies
Evaluate microneedle delivery for peptides, proteins, biologics and other complex payloads.
Drug-Delivery Companies
Combine proprietary molecules or formulations with an industrialization-oriented microneedle platform.
Early-Stage Programs
Generate feasibility data, prototypes and a development roadmap before larger investment decisions.
PROGRAMS WE CAN EVALUATE
Payloads and Product Concepts
Small-Molecule Drug ProductsPeptide and Protein DeliveryBiologic DeliveryVaccine DeliveryDermatology ProductsLocal Anesthetic and Pain-Management ProductsMetabolic and GLP-1-Related ResearchLong-Acting and Sustained-Release Concepts
These categories represent potential evaluation areas. Suitability and project scope must be determined individually.
STAGE-GATED DEVELOPMENT
A Pathway with Defined Inputs, Activities and Outputs
- 01
Feasibility Assessment
- Inputs
- Payload information, target dose, intended use and available development data.
- Activities
- Review payload properties, loading requirements, formulation constraints, delivery expectations and initial manufacturability.
- Typical Outputs
- Feasibility findings and a recommended next-step plan.
- 02
Formulation Development
- Inputs
- Payload samples and available physicochemical, formulation and stability data.
- Activities
- Screen polymer systems, excipients, drug-loading strategies and microneedle structures.
- Typical Outputs
- Candidate formulations and prototype patches.
- 03
Process Development
- Inputs
- Selected candidate formulation and product requirements.
- Activities
- Study preparation, mold filling, drying, demolding, backing and assembly parameters.
- Typical Outputs
- A controlled development-scale process and identified critical parameters.
- 04
Analytical & Performance Evaluation
- Inputs
- Prototype batches and defined quality attributes.
- Activities
- Evaluate content, morphology, mechanics, insertion, dissolution, release, permeation and stability as applicable.
- Typical Outputs
- Development data supporting formulation and process selection.
- 05
Pilot Scale-Up
- Inputs
- Selected formulation and development process.
- Activities
- Assess equipment fit, process window, repeatability and scale-dependent risks.
- Typical Outputs
- Pilot-scale results and a process-transfer proposal.
- 06
Clinical-Stage & Commercial Support
- Inputs
- Product pathway, target market, quality requirements and agreed project scope.
- Activities
- Define batch, documentation, quality, packaging and manufacturing requirements.
- Typical Outputs
- A project-specific development or manufacturing package.
DEVELOPMENT CAPABILITIES
Connected Workstreams, Not Isolated Tests
Feasibility Assessment
Review the payload, dose, intended use, stability constraints and initial product concept.
Formulation and Prototype Development
Screen polymers, excipients, loading strategies and structures to generate candidate patches.
Process Development
Define critical parameters across filling, drying, demolding, backing, assembly and packaging.
Analytical and Performance Evaluation
Use project-appropriate methods for content, morphology, mechanics, insertion, dissolution, release, permeation and stability.
Pilot Scale-Up
Assess equipment fit, repeatability, process windows and scale-dependent risks.
Clinical-Stage and Manufacturing Support
Define stage-appropriate batch, quality, documentation and manufacturing activities according to the agreed scope.
PUBLISHED RESEARCH
Selected Research Associated with the Platform
Two-Layer Sustained-Release Microneedles Encapsulating Exenatide for Type 2 Diabetes Treatment
Pharmaceutics, 2022
View DOI →Novel Dissolving Microneedles Preparation for Synergistic Melasma Therapy
International Journal of Pharmaceutics, 2021
View DOI →Novel Double-Layered PLGA Microparticles-Dissolving Microneedle System for Peptide Drugs Sustained Release
International Journal of Pharmaceutics, 2025
PROJECT INFORMATION CHECKLIST
What to Prepare for an Initial Discussion
- Payload identity and physicochemical properties
- Target dose and expected release profile
- Intended indication or application
- Current development stage and available data
- Target market and expected timeline
- Required development or manufacturing scope
FAQ
Common Project Questions
What information is needed for an initial feasibility assessment?
Non-confidential payload properties, target dose, intended use, current development stage and available formulation or stability data are usually sufficient for an initial discussion.
Does every peptide or biologic fit microneedle delivery?
No. Suitability depends on dose, potency, stability, loading capacity, delivery performance and manufacturability, and must be evaluated individually.
Can CASMN support both development and manufacturing?
CASMN connects feasibility, formulation, process and analytical work with pilot scale-up and project-specific manufacturing planning. Scope is confirmed for the applicable product category and development stage.
Is confidential information required before the first call?
No. A preliminary discussion can begin with non-confidential information. An NDA can be discussed before detailed technical information is exchanged.
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