Nucleic Acid Drug Process Development

CD Formulation's business scope covers a wide range of areas, including nucleic acid process development and optimization, pilot-scale sample production, and large-scale commercial production. Our team comprises industry veteran scientists and executives with extensive experience in nucleic acid formulation, supported by a comprehensive quality control system.

About the Process Development of Nucleic Acid Drugs

The aim of process development is to produce nucleic acid drug products with guaranteed quality, safety, and efficacy. The production process of a nucleic acid drug needs to be designed according to the characteristics of the product, and all steps in the manufacturing process of a nucleic acid drug product should be fully understood during the product development process. Assays, process controls, and quality standards in process studies are generated based on the information obtained during process development. The manufacturing process should be optimized to reduce unnecessary impact on clinical safety and efficacy. If changes to the manufacturing process occur, a comparability study is required to assess the potential impact of the changes on product quality, safety, and efficacy and to confirm that the improved manufacturing process provides a comparable product.

Fig.1 Nucleic acid drug process development. (CD Formulation)

Explore Our Nucleic Acid Drug Process Development Services

CD Formulation's team of experts and state-of-the-art facilities provide specialized support and innovative approaches. We have extensive experience in developing new processes that can be utilized for efficient and high-quality scale-up of nucleic acid drugs.

During the process development, it is necessary to ensure that the quality of the nucleic acid drug meets standards. The following lists routine analyses based on nucleic acid drugs.

• Purity Characterization
• Concentration Analysis
• Structural Characterization
• Physical and Chemical Characterization
• Impurity Identification
• Biological Activity

We also have unique experience and insights in the process development of nucleic acids.

• Process Design and Optimization for Nucleic Acid Drugs
• Process Scale-up Services for Nucleic Acid Drugs
• Manufacturing Process Validation for Nucleic Acid Drugs
• Quality Control for Nucleic Acid Drugs

Solutions for Nucleic Acid Drug Process Development

• Screening of routes for sustainable optimization

Regarding this point, the process usually adopts two response strategies:

• Comprehensively screen possible routes to find a suitable route for further optimization and pilot production.
• Follow the route of the preclinical study to achieve rapid delivery, while conducting further route screening and evaluation.

• Collecting process parameters and product information to provide data for the next stage of development

During this phase of process development, process chemists need to communicate more frequently and closely with various departments. When interacting with the analytical department, they must address the following:

• Developing an analytical method plan including precision, accuracy, versatility, validation, and other related issues and solutions.
• Speculating and identifying impurities.
• Establishing product indicators and intermediate indicators.
• Formulating R&D plans, such as determining when to provide standards and representative samples, among other tasks.

Our Technology Platform for Nucleic Acid Drug Process Development

Why Choose Us for Nucleic Acid Drug Process Development?

• The process development team has over years of experience in nucleic acid synthesis and preparation. They have successfully completed the production scale-up from milligrams to kilograms of nucleic acid products.
• Gathering outstanding nucleic acid chemists and engineers from both domestic and international backgrounds. The key technicians all hold doctoral or master's degrees, with unique expertise in analyzing key process control points of oligonucleic acid products, identifying sources of impurities in the process, and scaling up production.
• In accordance with the requirements of ICH guidelines, we complete process development and formulate process reports that strongly support the clinical filing of innovative nucleic acid drugs.

CD Formulation offers comprehensive nucleic acid production and manufacturing process services. As a supplier of nucleic acid drug formulations, we leverage cutting-edge technology, top talent, and advanced platforms to empower our customers in achieving efficient and cost-effective production objectives. Contact us for specialized solutions.

How It Works

STEP 1

Submit a service request describing your specific research or development need.

STEP 2

We'll email you to provide your quote and confirm order details if applicable.

STEP 3

Execute the project with real-time communication, and deliver the final report promptly.