At CD Formulation, we are a leading provider of comprehensive process scale-up services for nucleic acid drugs. Before entering volume production, nucleic acid drugs undergo a rigorous approval process and necessitate repeated production of small quantities for clinical, development, or stability purposes. Our technology platform can assist you in swiftly transitioning to volume production at any phase of your project.

About the Process Scale-up of Nucleic Acid Drugs

The ultimate goal of nucleic acid drug process development is to produce pharmaceutical products of high quality for medical applications. Before the research results are put into mass production, a mature, stable, and suitable technical process route for industrial production must be developed. The research and development process is carried out in stages, including: experimental research stage, small-scale trial preparation section, pilot production stage, and finally transitioning to industrial production. Each stage is interconnected and mutually reinforcing, with different tasks and research focuses, and the scale of preparation gradually changes from small to large. Pilot production should be completed before applying for the registration of new drugs.

Explore Our Nucleic Acid Drugs Process Scale-up Services

With years of experience in providing scale-up services to many well-known pharmaceutical companies, CD Formulation has an in-depth understanding and control of the entire scale-up process from laboratory to factory. We can develop a practical scale-up plan based on the characteristics of the customer's product to ensure a smooth scale-up process.

Small-Scale Production of Nucleic Acid Drugs

Our state-of-the-art R&D facilities are equipped with the latest technology to support small-scale production of nucleic acid drugs. Our experienced team of scientists and engineers work closely with you to develop and optimize manufacturing processes to ensure the highest levels of purity, potency, and consistency.

Pilot-scale Production of Nucleic Acid Drugs

At this stage, we work closely with you to design and implement robust process controls, optimize equipment and process parameters, and develop comprehensive quality assurance and quality control protocols. This holistic approach ensures the success of your nucleic acid drug as it progresses towards larger-scale production.

Mass Production of Nucleic Acid Drugs

When it comes time to transition to large-scale production, CD Formulation has the ability to handle the complexities with ease. Our state-of-the-art manufacturing facilities, equipped with the latest technology, allow us to reliably scale up production of nucleic acid drugs while maintaining the highest quality standards and regulatory compliance.

Our Integrated Solutions for Nucleic Acid Drugs

CD Formulation understands that the process of developing and commercializing nucleic acid drugs is multifaceted and requires interdisciplinary expertise. Therefore, we offer a comprehensive range of services to support you at all stages of the process, from early research and development to commercial production.

Our capabilities are not limited to manufacturing; we also offer formulation development, analytical method development, stability studies, and regulatory support services. By integrating these complementary services, we can provide a seamless end-to-end solution that optimizes efficiency, reduces timelines, and ultimately improves the success of nucleic acid drug projects.

Our Nucleic Acid Drugs Process Scale-up Technology Platform

• Nucleic Acid Chemical Synthesis Technology Platform
• Nucleic Acid Modification Technology Platform
• Purification and Separation Platform
• Analysis and Detection Technology Platform
• Formulation Technology Platform
• Process Scale-up Technology Platform

Our Workflow for Nucleic Acid Drugs Process Scale-up

Fig.1 Flow chart of nucleic acid drugs process scale-up. (CD Formulation)

Program Demonstration

Through an in-depth understanding of customer needs and product characteristics, we develop a comprehensive process scale-up program and conduct feasibility assessments to provide clear direction and guidance for subsequent process development.

Process Development

Optimize key process parameters such as nucleic acid synthesis, purification, and separation, molecular modification, etc., and establish a comprehensive quality control system and analytical testing methods to ensure the product's quality can be effectively controlled.

Pilot Test Validation

Utilize the pilot plant to conduct process scale-up validation tests to evaluate the consistency and stability of different process indicators, establishing the groundwork for future process scale-up.

Process Amplification

Further optimize the process parameters based on the pilot test results and management system, and execute the industrial production process in an organized manner.

Quality Control

Strictly implement the quality management system to ensure stable product quality and provide comprehensive technical documentation and production records.

Why Choose Us for Nucleic Acid Drugs Process Scale-up?

• Batch Production: Adopting the batch production method ensures a consistent supply of products from the same batch with sufficient stock.
• Short Lead Time: Independent research and development ensures meeting customer demand.
• Customizable: We offer customization services for unique samples, including species-specific, model-specific, and age-specific samples.

CD Formulation has established a comprehensive nucleic acid drug manufacturing technology platform, encompassing the entire process from raw material synthesis to formulation production. We have state-of-the-art production facilities and a robust quality management system in place to guarantee the stability and reliability of product quality. Contact us for customized solutions for nucleic acid process scale-up.