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Nucleic Acid Delivery System Development

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With more than 15 years of experience, CD Formulation has been a trusted partner for pharmaceutical and biotech companies in advancing nucleic acid therapies to market. Our highly skilled and multidisciplinary team combines expertise in materials science, drug formulation, biomedical engineering and pharmaceutical development.

Importance of Delivery Systems for Nucleic Acids

Nucleic acids, such as DNA and RNA, are susceptible to degradation by enzymes and harsh physiological conditions. A well-designed delivery system/formulation provides stability and protection, preventing premature degradation and ensuring the integrity of the nucleic acids during transit while functioning in the following areas:

  • Cellular uptake
  • Intracellular release
  • Targeting specificity
  • Pharmacokinetics and biodistribution
  • Immunogenicity and safety

What Can We Do for Nucleic Acid Delivery?

Excipient Customization

Our excipient customization services for nucleic acid delivery are designed to address the unique challenges of delivering nucleic acid-based therapeutics. Our experts combine in-depth knowledge of excipient selection and formulation design to create tailored solutions that maximize the efficacy and safety of nucleic acid delivery.

Common Formulation Development

We offer comprehensive nucleic acid drug formulation development services, specializing in various delivery routes. Our expertise includes the development of injection formulations for efficient systemic delivery, microneedle formulations for painless and targeted transdermal delivery, and mucosal delivery formulations for non-invasive administration.

Biomimetic Carrier Development

Leveraging insights into natural virus and bacteria transport mechanisms, our scientists design vehicles that mimic biology through cell-specific homing motifs and endosomal escape functionalities. We engineer biomimetic surfaces and encapsulate therapies within structures such as exosomes, protein cages and viral-mimetic nanoparticles.

Nanocarrier Development

We specialize in engineering novel polymer-, lipid- and inorganic-based platforms with tailored properties for loading, stabilization, targeting and controlled release of various nucleotide payloads. Our flexible project management approach involves material selection, rational design, formulation optimization, comprehensive characterization and quality control testing.

Hydrogel Development

Our team of formulation scientists and engineers designs and fabricates novel injectable hydrogel depots loaded with therapeutic nucleotides. Manipulating the physical and chemical properties of biopolymers and synthetic materials, we create hydrogels with controlled degradation and payload release kinetics optimized for specific tissues and indications.

Our Nucleic Acid Delivery System Analysis Services

Physicochemical Characterization
  • Particle Size/Shape Analysis (DLS, SEM, TEM)
  • Zeta Potential/Surface Charge
  • Drug Content/Encapsulation
Release Kinetic Testing
  • Dialysis-based Assays
  • HPLC/Mass Spec quantification
Stability Studies
  • Accelerated/Real-time Conditions
  • Effect of Temperature, Light, Freeze/Thaw
Nucleic Acid Integrity Analysis
  • Gel Electrophoresis
  • qPCR quantification
Biophysical Evaluation
  • Interaction Mechanism Studies
  • Binding Isotherms by ITC, SPR
Cellular Uptake Quantification
  • Flow Cytometry
  • Fluorescence Microscopy
Toxicology Assessment
  • Cytotoxicity Screening
  • Hemocompatibility

Applications of Our Nucleic Acid Delivery System Development Services

  • Gene Editing

Our platforms are engineered for delivery of CRISPR/Cas9, zinc finger nucleases and TALENs to allow precise genome editing.

  • RNA Therapy

We formulate nanoparticles, liposomes and polymers to transport messenger RNA, small interfering RNA, and antisense oligonucleotides for applications in oncology, immunology and beyond.

  • Vaccines

Our delivery systems are adapted for nucleic acid-based vaccines for infectious diseases and cancer immunotherapies.

Highlights of Our Nucleic Acid Delivery System Development Services

  • Multidisciplinary expertise in materials science, pharmaceutical development, and nanomedicine enables the rational design of optimized delivery platforms.
  • Full-service offerings include formulation, comprehensive characterization, in vitro and in vivo testing.
  • Deep experience advancing nucleic acid programs into the market using polymeric nanoparticles, lipid nanoparticles, viral and non-viral vectors.
  • Proprietary modular platforms can be rapidly adapted to new chemistry and payload modes.

CD Formulation helps customers realize the clinical potential of nucleotide therapeutics through customized projects and platform technologies. To discuss how our nucleic acid delivery system development could accelerate your program's progress, please contact us!

References

  1. Lu Z.R.; Shi G.H. Nucleic acid delivery. Pharm Res. 2023, 40(1):1-2.
  2. Gupta A.; et al. Nucleic acid delivery for therapeutic applications. Adv Drug Deliv Rev. 2021, 178:113834.
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