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Nucleic Acid Injection Formulation 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 are Nucleic Acids Administered by Injection?

Nucleic acid therapies such as gene therapy, mRNA vaccines, and gene editing tools hold immense potential but face challenges in navigating biological barriers to reach target cells. Systemic injection is currently the most common administration route for nucleic acids due to poor absorption and instability when delivered other ways like orally. With a rapid onset of action and the ability to control dosage, injectable administration allows for immediate and personalized treatment responses. Through optimized excipients and targeted formulations, injection aims to deliver nucleic acids precisely to desired sites of action.

What Can We Do for Nucleic Acid Injectable Formulation Development?

Nucleic Acid Injection Formulation Development – CD Formulation

  • Administration Method Selection

The choice of administration site depends on factors such as the indication for treatment, desired biodistribution, and therapeutic goals. Our services are flexible and can adjust the formula according to customer needs to adapt to different drug action environments.

  • Intramuscular (IM)
  • Intravenous (IV)
  • Subcutaneous (SC)
  • Intratumoral (IT)
  • Intradermal (ID)
  • Formulation Optimization

We work closely with clients to optimize the formulation, considering factors such as stability, solubility, and compatibility with injectable delivery systems.

Excipient Selection and Customization

We identify and customize excipients to enhance the efficacy and safety of nucleic acid injectables, focusing on factors such as targeted delivery, controlled release, and minimized immunogenicity.

  • Novel Delivery System Design

Nucleic acid can be delivered with CD Formulation's innovative delivery systems. Considering factors such as particle size, surface charge and stability, we can use technologies such as lipid nanoparticles and nanogels to encapsulate nucleic acid vaccines or drugs to ensure effective cellular uptake and tissue targeting.

  • Preclinical Studies

We conduct preclinical studies to evaluate the safety, pharmacokinetics, biodistribution, and efficacy of nucleic acid injectable formulations, providing essential data for further development.

How Do We Develop Nucleic Acid Injection Formulations?

How Do We Develop Nucleic Acid Injection Formulations

  • Excipient screening to identify components that safely encapsulate and release nucleic payloads.
  • Nanoparticle engineering techniques to produce injectable formulations with controlled size, charge and targeting.
  • Physicochemical analysis of critical quality attributes for manufacturability and injectability.
  • In vitro testing in cell and tissue models to assess transfection, expression and immune response.
  • In vivo biodistribution and efficacy studies in animal models via relevant injection routes and doses.
  • Toxicology studies to evaluate the initial safety of lead candidates.

Applications of Our Nucleic Acid Injection Formulation Development Services

  • Gene Therapy Development

We offer formulation services to assist with the precision delivery of nucleic acid injectables for gene therapy applications. We work to create efficient systems that encapsulate therapeutic genes, protecting them while transporting the payloads to targeted cell and tissue sites. This facilitates the treatment of genetic disorders and other diseases modulated at the molecular level.

  • Nucleic Acid Vaccine Development

We apply our formulation expertise to advance injectable nucleic acid vaccine candidates. Customized excipients and engineered delivery systems can improve the stability, immunogenicity and biodistribution of genetic vaccine materials.

Advantages of Our Nucleic Acid Injection Formulation Development Services

  • Our services support the development of injectable DNA vaccines, mRNA vaccines, and viral vector-based vaccines administered via intramuscular or subcutaneous routes.
  • Excipient selection and engineering enhance stability, biodistribution and cell-specific uptake of nucleic acid drugs and vaccines.
  • Our flexible platform allows tailoring of excipients, particles, routes and doses to specific applications.
  • Projects are designed to accelerate the development process through trial design, quality control and standardized toxicology.

CD Formulation offers comprehensive nucleic acid injection development services to support the translation of gene therapies, vaccines, and other nucleic acid drugs. By leveraging our expertise and integrated platform, we aim to facilitate your nucleic acid therapeutic's commercial success. Contact us to know how we can help!

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