CD Formulation is dedicated to providing comprehensive route scouting and development services, focusing on designing and optimizing synthetic routes to meet the demands of the modern pharmaceutical industry. These services are not just aimed at improving synthesis efficiency but also at ensuring the commercial viability and environmental friendliness of nucleic acid drugs.
In the development of nucleic acid drugs, route scouting and development are crucial. It is not only an effective way to reduce production costs but also enhances synthesis efficiency and stability, laying the foundation for successful commercialization. Optimized synthesis routes can significantly impact production costs and market competitiveness, helping drugs reach the market more quickly. At the same time, choosing synthesis routes that comply with environmental and safety standards is also the responsibility and pursuit of modern pharmaceutical companies to ensure compliance. Furthermore, ongoing route optimization drives innovation, assisting in the development of new drugs and the enhancement of existing products to maintain a competitive edge in the market.
There are several factors that require special attention during the route scouting and development of nucleic acid drugs, as they will directly influence the final route selection and successful development.
CD Formulation provides a range of services in route scouting and development, from basic route design to complex process validation, covering all stages of nucleic acid drug development.
Services | Descriptions |
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Synthesis Route Development and Scouting |
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Process Development, Optimization, and Validation |
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Safety Assessment |
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Analytical Method Development and Validation |
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Stability Studies |
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Fig.1 Flow chart of route scouting and development for nucleic acid drugs. (CD Formulation)
Researching the latest technology and literature resources to propose multiple synthesis plans and evaluate their theoretical feasibility for further testing.
Conducting a series of operability experiments on selected routes in a small-scale laboratory to verify their practical applicability and reaction efficiency.
Systematic process adjustments and reagent configuration optimizations are carried out to improve overall synthesis performance based on issues and optimization opportunities identified during the experiments.
Successfully transitioning from small-scale to pilot testing to evaluate the practicality and economic value of the route at different production scales.
Based on multiple successful pilot tests, verify the stability and repeatability of the process to provide reliable evidence for subsequent large-scale production.
CD Formulation has an advanced technology platform and equipment configuration that can support the entire process development from small-scale experiments to multi-kilogram production. Our primary instruments include HPLC, GC, NMR, etc., ensuring efficient synthesis and analysis.
Technology: Drug process development utilizing machine learning and artificial intelligence platforms.
Journal: Organic Process Research & Development
IF: 4.8
Published: 2024
Results:
This perspective aims to: (1) introduce synthetic drug process development to those in machine learning (ML) and artificial intelligence (AI); (2) break down the process into simpler sub-tasks; and (3) highlight where ML and AI can be effectively applied. While ML and AI have long been discussed in pharmaceutical synthesis, leading to the creation of computer-aided planning tools, the focus has traditionally been on inverse synthetic analysis in medicinal chemistry. This leaves many unexplored opportunities for using ML and AI to aid process chemists and engineers in drug process development.
Fig.2 Advance synthetic drug substance process development. (Griffin D J, et al., 2023)
CD Formulation is committed to providing technologically advanced and comprehensive solutions in route scouting and development for nucleic acid drugs, assisting your project in achieving commercial success. Feel free to contact us, our professional team is always ready to assist you.
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