At Protheragen-ING AI-Pharma, we offer specialized Contract Development and Manufacturing Organization (CDMO) services for small nucleic acid drugs, catering to the growing demand for innovative therapies such as RNA-based treatments and gene-editing technologies. Small nucleic acid drugs, including RNA and DNA oligonucleotides, are pivotal in advancing personalized medicine and therapeutic interventions. These drugs require precise synthesis methods and rigorous quality control to ensure their efficacy and safety.
Traditionally, a range of methods for small nucleic acid drug development have been utilized, including:
At Protheragen-ING AI-Pharma, we use liquid-phase synthesis to manufacture stable and safe small nucleic acid drugs, offering high precision and scalability. This technique involves the chemical synthesis of nucleic acids in a liquid solution, allowing controlled and efficient production.
Liquid phase synthesis utilizes automated systems to perform chemical reactions in solution.
Sequential Addition: Nucleotide monomers are added sequentially to a growing chain in a liquid phase using automated systems.
Controlled Conditions: The process is carefully controlled to manage reaction conditions, including temperature, pH, and reagent concentrations.
Purification: The resulting oligonucleotide is purified using techniques such as high-performance liquid chromatography (HPLC).
Protheragen-ING AI-Pharma offers comprehensive formulation development and GMP-compliant scale-up production services designed to support the successful transition of your product from concept to market. Our formulation development process begins with in-depth pre-formulation studies to assess the API's characteristics and compatibility with excipients. We leverage this data to design robust, efficient formulations tailored to your specific needs, until this formulation can be seamlessly transitioned to scale-up production. Protheragen-ING AI-Pharma meticulously adheres to Good Manufacturing Practice (GMP) standards, optimizing the manufacturing process to maintain consistency, quality, and regulatory compliance throughout.
1. Scalability: Liquid-phase synthesis facilitates easy scaling from small laboratory batches to larger production volumes, accommodating varying quantities of nucleic acids as needed.
2. Flexibility: This method allows for the synthesis of a wide range of nucleic acid sequences with high accuracy, making it suitable for complex and diverse oligonucleotide designs.
3. Enhanced Purity: The liquid-phase environment supports better separation of products and impurities, leading to high-purity final products.
4. Automated Processing: Automated systems can be employed to streamline the synthesis process, improving reproducibility and efficiency.
Our liquid-phase synthesis approach ensures that small nucleic acid drugs are produced with exceptional precision and quality, supporting the development of cutting-edge therapies. With our expertise and advanced technology, Protheragen-ING AI-Pharma is well-equipped to meet your specific needs in nucleic acid drug development, offering reliable and scalable solutions to drive your innovative projects forward. For more details on our small nucleic acid drug CDMO services and how we can assist you, please contact us.