As a leading service provider in the industry, CD Formulation is committed to offering comprehensive small-scale production solutions to our clients. By integrating advanced process development technologies and flexible laboratory conditions, we assist our clients in exploring and optimizing synthetic processes that meet commercial scale production requirements. This approach not only accelerates the development process of innovative drugs but also ensures an optimal balance between safety and efficiency.

About Small-Scale Production of Nucleic Acid Drugs

Nucleic acid drugs involve complex molecular structures and multi-step chemical synthesis processes. To achieve large-scale production and meet clinical application demands, process validation must first be conducted on a small scale. Through small-scale production, it is possible to discover a cost-effective and efficient synthetic route while ensuring product quality. Small-scale production allows for flexible adjustments of process parameters, optimized reaction conditions, and validation of feasibility and economic efficiency under actual conditions. Additionally, small-scale production provides essential data and technical support for subsequent scale-up.

Fig.1 Small-scale production of nucleic acid drugs. (CD Formulation)

Explore Our Small-Scale Production Services for Nucleic Acid Drugs

• Custom Small-Scale Production Services

We develop exclusive production schemes for each nucleic acid drug, taking into full consideration their unique molecular structures and chemical properties. We simulate real production environments under laboratory conditions to ensure the reliability and efficiency of production processes. Custom-designed schemes allow for rapid adjustment of production parameters, achieving efficient process development on a small scale.

• Optimal Synthetic Route Design

When designing synthetic routes, we focus on minimizing unnecessary steps and by-products while enhancing overall yield. This includes selectively using the latest catalysts and reaction conditions to shorten synthesis pathways and reduce energy and resource consumption. Leveraging our rich chemical knowledge and experimental experience, we ensure that each route performs excellently in practical applications.

• Substitution with Industrial-Grade Raw Materials

We carefully select and verify the purity and reactivity of each industrial-grade material to ensure stable product quality and yield even under scale-up conditions. This process significantly reduces production costs while meeting commercialization needs.

• Reuse of Raw Materials and Solvents

We precisely monitor solvent changes during reactions and formulate detailed recovery plans to ensure that reclaimed materials can be reused safely and efficiently. Our goal is to establish a closed-loop production process that conserves resources and effectively minimizes environmental impact, enhancing the eco-friendliness of the process.

• Analysis of Nucleic Acid Drug Products

Employing advanced analytical technologies such as liquid chromatography-mass spectrometry, we conduct comprehensive evaluations of products to ensure they meet quality control standards. We investigate not only the chemical stability and physical properties of the products but also thoroughly test the uniformity and safety of each batch. Through regular and in-depth analysis, we can anticipate potential issues in advance, guaranteeing that each batch meets the predetermined standards and providing clients with reliable nucleic acid drug products.

Considerations for Small-Scale Production of Nucleic Acid Drugs

Workflow of Small-Scale Production of Nucleic Acid Drugs

Fig.2 Flow chart of small-scale production for nucleic acid drugs. (CD Formulation)

• Materials Preparation

We provide high-purity nucleic acid raw materials along with other necessary reagents and consumables, conducting strict quality inspection and documentation.

• Sequence Synthesis

Our researchers synthesize short-chain oligonucleotides according to the designed sequence, gradually extending the chain length to the target sequence through chemical synthesis techniques.

• Purification Process

Our technicians utilize HPLC and other purification technologies to remove impurities and unreacted materials, ensuring the purity and quality of the final product.

• Quality Control Testing

The quality control team conducts multiple quality assurance tests on the synthesized nucleic acid drugs, including sequencing, purity testing, and concentration determination, to verify their compliance with design standards.

Our Technology Platforms

We utilize advanced synthesis platforms and analytical technologies, including HPLC and NMR, to ensure product quality meets international standards.

Our Advantages of Small-Scale Production of Nucleic Acid Drugs

• A team of experienced scientists and technical experts providing comprehensive support from synthesis process development to product quality testing.
• Tailored production schemes based on specific client needs and the unique nature of nucleic acid drugs, ensuring efficient and customized process designs.
• A project management system and production process design that quickly responds to market and client changes, offering flexible production arrangements and timely service support.
• Implementation of comprehensive quality control measures ensuring each product batch meets stringent domestic and international quality standards.

Publication Data

CD Formulation's expert team is always ready to provide professional support and advice, ensuring your product achieves optimal performance at every stage from concept to market. Regardless of your project's current stage, feel free to contact us to jointly promote innovation in nucleic acid drugs.