CD Formulation's professional R&D team, with extensive experience and capabilities, utilizes ample resources, complete production equipment, and advanced facilities. As your long-term strategic partner, we aim to provide customers with high efficiency, maximize production capacity, save customers' time and costs, and deliver reliable and cost-effective nucleic acid drugs.

Goals of Nucleic Acid Drug Process Design and Optimization

Improve Quality

This includes increasing content, reducing impurities, improving appearance and color, enhancing flowability, and extending shelf life.

Reduce Costs

Including improving yield, replacing raw materials, shortening reaction cycles, and recovering solvents, among others.

Improvement of Large-Scale Production Capacity

Refers to the optimization of increasing production capacity under the conditions of the existing production process, including the adjustment of batch size, fine-tuning of scale-up process parameters, etc.

Reduce Waste Emissions

Refers to the optimized treatment of the three types of waste (gas, liquid, solid), including the absorption of waste gas, the recycling of waste liquid, and the utilization of waste residue.

Fig.1 Advantages of nucleic acid process design and optimization. (CD Formulation)

Explore Our Services for Nucleic Acid Drug Process Design and Optimization

Every stage of drug preparation and optimization impacts your final product and raises costs. At CD Formulation, we possess the expertise to optimize each stage, guaranteeing that you achieve the desired results and attain the highest level of efficiency throughout the process.

We combine our expertise in materials and processing with the knowledge we have gained over the years by collaborating with clients from various industries on a wide range of projects to assist you in developing and optimizing your products. Our current services for nucleic acid design and optimization encompass raw material screening and optimization, reaction condition optimization, and route exploration and development for nucleic acid drugs.

Our Capabilities

Route Design and Development

• Evaluation of existing synthetic routes is necessary to determine if they meet the requirements for scale-up, cost, safety, and quality control.
• Propose new synthetic routes by experienced chemists, and conduct laboratory validation and optimization.
• Rapid exploration and optimization of key reaction steps using parallel reaction equipment and high-throughput screening platforms.
• Application of new technologies to convert previously unfeasible steps into feasible ones.
• Establish efficient hazardous chemical handling capabilities to support route development and the overall research and development (R&D) process.
• Evaluate the suitability of current routes or procedures for scaling up in relation to material cost, safety, cycle time, operability, etc., through literature research.

Process Development and Optimization

• Develop fit-for-purpose process development strategies and quality control programs.
• Development of final optimized processes for commercial production.
• Ability to safely handle highly reactive compounds.
• Support for process development and project transfer through chemical engineering simulations.
• Perform laboratory-scale testing of materials and products to ensure they are ready for production.
• Develop new manufacturing or processing lines or retrofit existing ones.
• Troubleshooting to determine the cause of problems during processing.
• Perform raw material/component acceptance testing through spot checks or routine testing.
• Validate new material supplies and process changes to ensure compliance with specifications.
• Perform impurity analysis and characterization, synthesize reference materials, and establish impurity control targets.
• Conduct design space studies using Design of Experiments (DOE) tools based on Quality by Design (QbD) principles.
• Scale-up of technology from lab to pilot to production scale.

R&D Support

Our experts work side by side with R&D and engineering teams to help bring novel or improved products to the market.

Our Workflow for Nucleic Acid Drug Process Design and Optimization

Fig.2 Flow chart of nucleic acid drugs process design and optimization. (CD Formulation)

Synthetic Route Development

The first step is to design a feasible synthetic route based on the structural characteristics of the target nucleic acid molecule. Factors such as reaction reagents, reaction conditions, reaction sequence, and other variables need to be considered.

Analytical Method Development

In order to comprehensively assess the quality of the product, it is necessary to establish analytical methods for the physical and chemical properties of raw materials, intermediates, and final products. Techniques such as HPLC, mass spectrometry, and nuclear magnetic resonance are essential. Additionally, determining quality control indexes, including purity, impurity profiles, and content, is crucial.

Purification Process Optimization

After determining the synthetic route, it is necessary to evaluate the separation and purification techniques, such as chromatography, crystallization, membrane separation, etc., and select the appropriate method.

Scale-up Study

In order to transition from the laboratory to the plant, it is necessary to establish a mathematical model of reaction kinetics and mass transfer characteristics to provide a theoretical basis for process scale-up.

Environmental Safety Assessment

While developing the production process, we also need to analyze the environmental impact of the production process, such as solvent emissions, energy consumption, etc., and adopt green chemistry technology.

Intelligent Manufacturing Optimization

Finally, process analysis technologies, such as Process Analysis Technologies (PAT), should be applied to achieve real-time monitoring and control of key process parameters.

Publication Data

With a profound industry background, a comprehensive technology platform, and extensive project experience, CD Formulation can offer customers high-quality services for nucleic acid drug process design and optimization. We can assist customers in successfully launching their products. Contact us, and we will persist in our efforts to contribute to the advancement of the nucleic acid drug industry.