CD Formulation has extensive experience in nucleic acid formulation development and can offer customers comprehensive support ranging from vector development and optimization to dosage form development. Our expert team will tailor solutions to meet your specific requirements. Throughout the formulation development process, we will carefully choose appropriate carrier materials, refine the prescription composition and preparation procedures, and establish quality control standards. With our skilled R&D team, advanced analytical testing techniques, and research environment compliant with drug regulations, we are well-equipped to deliver top-notch nucleic acid therapeutic formulation development services to support your success in new drug discovery and development initiatives.

Why Nucleic Acid Therapeutic Formulation Development?

Nucleic acid drugs are synthetic DNA or RNA fragments with therapeutic functions. These drugs can act directly on disease-causing target genes or target mRNAs to treat diseases at the genetic level. Formulation development is an essential aspect of drug discovery. Early formulation studies do not require complete prescription development. All studies are focused on toxicology and ease of administration during Phase I. The objective is to expedite the drug candidate's entry into clinical trials. As the project advances, the mode of administration and prescription studies become more comprehensive. For instance, some drugs are poorly absorbed in the stomach and intestines and may need to be developed as injectables. Some drugs are rendered inactive in stomach acid, necessitating development as enteric formulations. There are also compounds that do not dissolve well, and formulating them can partially address this issue.

Fig.1 Delivery systems for nucleic acid therapeutics development. (Kulkarni J A, et al., 2021)

Explore Our Nucleic Acid Therapeutic Formulation Development Services

CD Formulation offers services in drug carrier development, physicochemical characterization, and various formulation technologies. These services include GalNAc nucleic acid coupling development, design of sustained- and controlled-release delivery systems, development of oral formulations (such as conventional tablets and capsules), injectable formulations, spray-drying technology, solid dispersion technology, and hot-melt extrusion technology.

Our technology platform offers comprehensive durability assessment for nucleic acid drug formulations, providing a one-stop solution for our partners. We assist nucleic acid partners in identifying challenges and risks in the drug development process and offer timely solutions to optimize costs and accelerate the drug's market entry.

During the development of nucleic acid therapeutic formulations, there is a need to compare stability, efficacy, and feasibility, and accordingly select different controlled drug release options. Our extensive experience with various drug carrier development, delivery routes, drug delivery systems, and drug manufacturing technologies can be formulated into the following programs:

• Nucleic Acid Drug Delivery Carrier Development
• Design and Optimization Services for Nucleic Acid Drug Delivery System
• Dosage Form Development for Nucleic Acid Therapeutic Formulation

Our Solutions for Nucleic Acid Therapeutic Formulation Development

Nucleic acid drugs can be stabilized, and their bioavailability can be improved through selected controlled release routes. Controlled release can be optimized through various specific routes, such as solvents, nasal sprays, capsules, and tablets. CD Formulation's analytical platforms are equipped with a full range of nucleic acid synthesis and purification equipment, from laboratory to plant scale, to meet the needs of nucleic acid production from grams to kilograms. The complete analytical facilities, such as HPLC and MS, provide protection for nucleic acid structure characterization, analytical method development and validation, production control, final product release testing, and stability studies.

Our Capability

• Determination of Content and Homogeneity
• pH Testing
• Density Testing
• In Vitro Release Testing of Drugs
• Particle Size Distribution Analysis
• Moisture Determination

Our Nucleic Acid Therapeutic Formulation Platform

CD Formulation has specialized in formulation development technology and a complex formulation development process to create intricate formulations with various in vivo delivery effects tailored to the characteristics of different nucleic acid drugs. These aspects include, but are not limited to:

Formulation Development Platform

Research on the solid crystalline nature of the drug and formulate appropriate formulation development strategies based on the assessment of durability.

Solubilization Technology Platform

Development and evaluation of solubilization technologies for solid dispersions, nanocrystals, inclusion compounds, emulsions, etc.

Carrier Development Platform

Development and evaluation of complex formulation carriers such as liposomes, microspheres, nucleic acid coupling compounds, etc.

Analytical Method Development Platform

Development and validation of various analytical methods for technologies and complex formulations.

Evaluation Platform

Evaluation platform includes in vitro physical and chemical characterization, in vitro cytological evaluation, and in vivo pharmacodynamic evaluation.

Why Choose Us for Nucleic Acid Therapeutic Formulation?

• Reliable R&D team

• The R&D team comprises several PhDs who have been working in the field of nucleic acid drug discovery and development for many years.
• The R&D team members have extensive experience in drug carrier development and formulation. They have successfully completed the scale-up production of nucleic acid drug products, ranging from milligrams to kilograms.

• Introduction of International Advanced Instruments and Equipment

• We have a professional technical platform that includes advanced analytical testing methods, such as liquid chromatography, UV spectrophotometry, pH testing, etc.
• Equipment is regularly maintained and calibrated to ensure accurate and reliable data.

• Customer Services

• Under the premise of ensuring the compliance of raw materials and auxiliary materials used in nucleic acid formulations, we prioritize the auxiliary materials specified or suggested by customers.
• Customized formulations are available to provide customers with testing solutions.

CD Formulation has a mature project management system, advanced and complete equipment and facilities, and a customer-oriented service concept. These elements ensure rapid responses to customer orders from quotation to delivery. Our collaborative approach with clients and our professional services can expedite our clients' drug discovery process. Contact us, and we will customize the most professional and comprehensive services for you.