Formulation
Assess the molecule’s properties, dose requirements, and stability before selecting a delivery format.
NOVELTY PHARMACEUTICAL / PHARMACEUTICAL
Drug Delivery R&D
We work with pharmaceutical developers and research teams to explore dissolving microneedle delivery. Each project starts with the molecule, dose, and intended use, then brings formulation, design, testing, and development planning together.
FORMULATION · STRUCTURE · TRANSLATION
Build the evidence for a new delivery approach.
Define the question, agree on the evidence, and plan the next stage.
R&D DISCUSSION FRAMEWORK
Start with the product requirements
Array design
Develop the matrix, needle geometry, payload location, and application method together. Loaded content and delivered dose must be measured separately.
Performance testing
Define methods and criteria for integrity, release, insertion, activity, and stability.
Scale-up planning
Identify the resources and responsibilities for process transfer, quality planning, clinical supply, and regulatory work.
RESEARCH COLLABORATION AREAS
Research areas
Small molecules
Evaluate solubility, stability, local exposure, and the intended treatment setting.
Peptides and bioactives
Study activity retention, loading, and release against the required dose and available array capacity.
Vaccines and biologics
Explore antigen stability, delivery formats, immune-response testing, and downstream development needs.
Research goals and responsibilities are agreed for each project.
DEVELOPMENT PATHWAY
A staged development approach
01 Define the target product
Agree on the intended use, population, dose, reference route, and treatment setting.
02 Assess feasibility
Set the study scope, materials, and criteria for a go/no-go decision.
03 Develop the formulation and process
Refine the array, analytical methods, packaging, and quality attributes.
04 Plan nonclinical and regulatory work
Assign responsibility for pharmacology, exposure, safety, and quality data.
05 Prepare for clinical development
Confirm prerequisites and coordinate the sponsor, study sites, and supply partners.
06 Review the next step
Use the evidence to guide optimization, transfer, or further development.
This framework describes a potential development path. It does not indicate the status of any Novelty drug program.
CLINICAL DEVELOPMENT INTERFACE
Plan for clinical development
Before a study begins, partners need to agree on the candidate, research question, application method, sample quality, and supporting data.
Early clinical studies may evaluate safety, tolerability, drug exposure, or immune response. Later studies address the intended population and dosing regimen. Study design depends on the product and the question being asked.
We welcome discussions with developers, research institutions, and qualified partners to define the evidence needed and each party’s role. Project details will be shared when confirmed and cleared for disclosure.
COLLABORATION MODELS
Choose the right partnership model
Feasibility studies
Answer a defined research question and use the findings to guide the next decision.
Co-development
Share objectives, work packages, milestones, materials, and project responsibilities.
Technical development
Address a specific formulation, design, or testing need with agreed deliverables.
Technology transfer
Plan process documentation, transfer activities, and coordination with qualified manufacturing partners.
Licensing and strategic partnerships
Discuss rights and longer-term arrangements once the technology and intellectual property are defined.
The scope of each partnership is agreed before work begins.
FROM DISCUSSION TO A STAGE DECISION
How a project gets started
Start with the candidate, intended use, dose range, preferred format, available materials, and timeline. Confidential information and samples are shared under agreed terms.
Each stage has a clear question, deliverables, responsibilities, and decision criteria.
STRUCTURE & FACILITY INFORMATION
The platform behind the research
Our SEM images document array and needle structure. Delivery, drug loading, safety, and clinical performance require separate studies.
Nantong supports our existing operations. The Yangzhou facility is being fitted out, with completion planned for late 2026 and production planned for Q1 2027. Construction progress does not establish pharmaceutical manufacturing authorization.
The nonclinical, clinical, and manufacturing resources required for each project are confirmed during planning.
R&D; COLLABORATION
Talk to our R&D team ↗Tell us about your development challenge
What are you developing, what delivery problem needs to be solved, and what evidence do you need next?