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Nucleic Acid Microneedle System Development

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Dedicated to advancing nucleic acid therapeutics, CD Formulation is a leading biologics formulation company. With our specialized nucleic acid injection development platform, we provide end-to-end support from excipients to nanoparticle engineering. Our goal is to efficiently transform promising nucleic acid drugs into safe and effective injectable products and accelerate development progress.

Why Choose Microneedle Systems for Nucleic Acid Delivery?

Due to the unique barriers presented by these large, fragile biomolecules, microneedle arrays have emerged as a promising approach to nucleic acid drug delivery. These arrays contain short micron-sized needles that penetrate the outer layer of the epidermis to access skin micron-structure networks for efficient local or systemic uptake of genetic therapeutics. By allowing patients to self-administer their medications, microneedle systems can improve patient convenience. It is promising that microneedle systems will significantly advance nucleic acid drug delivery and therapeutic outcomes.

Microneedle system for nucleic acid deliveryMicroneedle system for nucleic acid delivery (Noh I.; et al. 2022)

What Can We Do for Nucleic Acid Microneedle System Development?

Array Design & Fabrication
  • Computational modeling to define array geometry for targeted drug distribution.
  • 3D printing, laser cutting, lithography or other techniques to create master molds.
  • Molding of dissolvable/biodegradable polymers like silicone, carbohydrate or PLGA to manufacture arrays.
Formulation Development
  • Material testing to select polymers/coating materials compatible with nucleic acids and skin.
  • Excipient screening to optimize drug solubility, stability and release kinetics.
  • Microinjection molding or microfluidics to load/coat arrays under aseptic conditions.
In Vitro Testing
  • Diffusion/permeation studies using skin/membrane models to evaluate array performance.
  • Stability assessment under various storage/environmental conditions.
  • Skin localization and cytotoxicity analysis using histology and cell-based assays.
In Vivo Evaluation
  • Pharmacokinetic profiling in small and large animal models via sampling of blood/tissue.
  • Proof-of-concept efficacy studies in disease models using molecular/clinical endpoints.
  • Assessment of safety, irritation and immunogenicity potential.

Types of Microneedle Systems We Can Develop

  • Solid Microneedle Arrays
  • Hollow Microneedle Arrays
  • Coated Microneedle Arrays
  • Dissolving Microneedle Arrays

Applications of Our Nucleic Acid Microneedle System Development Services

  • DNA and RNA Vaccines

Our services support the efficient design and testing of nucleic acid microneedle vaccine patches. We optimize polymer formulations and array geometry to stable deliver plasmid DNA or mRNA antigens through the skin. We then validate effective antigen expression and immune stimulation through careful in vitro and in vivo assessments, leading to targeted preventive or therapeutic vaccine development via this convenient delivery method.

  • Gene Therapy

Researchers exploring cutaneous or systemic gene therapies can leverage our expertise in developing optimized microneedle platforms for precise delivery of therapeutic genes. We work with partners to engineer DNA or CRISPR/Cas9 microneedle patches undergoing preclinical testing, assessing transgene expression kinetics and efficacy in relevant disease models.

  • Combination Therapies

Our formulation scientists develop microneedle patches incorporating nucleic acids with small molecules or proteins to produce synergistic effects. Precise co-encapsulation and co-delivery is tested in vitro and in vivo to evaluate combined therapeutic potential for applications such as cancer immunotherapies or treatment of complex genetic disorders.

Highlights of Our Nucleic Acid Microneedle System Development Services

  • Array design optimization through 3D printing and microscopy.
  • Polymer formulation and payload loading using microinjection molding.
  • Formulation development for enhanced stability and bioavailability.
  • Rigorous testing and evaluation for safety and efficacy.
  • Localized and targeted drug delivery with minimized off-target effects.

CD Formulation specializes in providing comprehensive microneedle system development services for efficient nucleic acid delivery. Our interdisciplinary team leverages extensive expertise to advance client products. If your research could benefit from our formulations or transdermal capabilities, please contact us and let us collaborate to accelerate the transition of innovative nucleic acid therapies to market.

Reference

  1. Noh I.; et al. Microneedle systems for delivering nucleic acid drugs. J Pharm Investig. 2022, 52(3):273-292.
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