CD Formulation specializes in quality control services for nucleic acids. The company has a comprehensive analytical method lifecycle management system that includes the implementation of quality control, continuous method improvement, and method performance monitoring during product process development.

About Quality Control for Nucleic Acid Drugs

Nucleic acid drug quality control is the final hurdle for drug release, serving as a crucial guarantee for drug quality. Pharmaceutical companies must establish impeccable quality control laboratories equipped with advanced analytical testing equipment and instruments, such as HPLC, GC, UV, IR, MS, etc. Additionally, these companies need to implement a comprehensive drug traceability system that uniquely identifies each production batch and records information from raw materials to finished products. This ensures that the quality of drugs can be traced, verified, and controlled. Simultaneously, pharmaceutical companies should prioritize adverse reaction monitoring, promptly collecting, analyzing, and evaluating drug quality and safety signals.

Fig.1 Examples of methods used for evaluation of DNA quality. (Didelot A, et al., 2013)

Explore Our Nucleic Acid Drugs Quality Control Services

CD Formulation has a professional analytical R&D and quality study team that can provide quality study and stability study services for nucleic acid formulations that meet the filing requirements. Our project experience covers all stages from formulation development to formulation scale-up, including method development and optimization, method validation and transfer, physicochemical property studies, stability studies, control standardization, and more, meeting the needs at various stages of the drug development process. Our current services include the following.

Batch-to-Batch Consistency Testing for Nucleic Acid Drugs

Stability Studies for Nucleic Acid Drugs

Batch Release Testing for Nucleic Acid Drugs

Results are obtained by testing and examining drug quality control programs. Based on these results, the quality of the drug formulation is evaluated and interpreted. Confirmation of compliance with relevant pharmacopeial standards, regulatory requirements, and internal quality standards is essential. In case of any non-conformity results, the cause needs to be analyzed, and appropriate quality control measures need to be taken to ensure the stability and consistency of the drug preparation.

Our Technology Platform for Nucleic Acid Drugs Quality Control

We offer a comprehensive platform for drug analysis and quality research, supported by a proficient drug analysis team. Our team can develop a variety of analytical methods and establish product quality standards for your products. Our analytical laboratory is equipped with high-precision instruments, including LC, GC, LC/MS, ICP/MS, IR, fully automated drug dissolution instruments, vertical diffusion cells, and more. Our skilled drug analysts are well-versed in various regulations and guidelines, enabling them to develop diverse analytical methods and set up product quality standards for your products.

Our Workflow for Nucleic Acid Drugs Quality Control Services

Fig.2 Our workflow for nucleic acid drugs quality control. (CD Formulation)

Establishment of Quality Standards

We can establish clear and specific quality standards as the basis of quality control. This includes standards for nucleic acid raw materials, specifications for intermediates and final products, and confirmation and validation of analytical methods.

Control of Raw Materials

The quality of raw materials directly affects the quality of drug products. Quality control should start at the source, with rigorous auditing and evaluation of raw material suppliers to ensure that the raw materials they provide meet predetermined quality standards.

Validation and Control of Production Processes

Nucleic acid drug manufacturing processes must undergo rigorous validation to ensure that they can consistently produce products that meet predetermined quality standards. This includes process validation, cleaning validation, equipment validation, etc. Throughout the production process, monitoring and control systems for key process parameters should be established, and detailed records and audits should be conducted for each production step.

Development and Validation of Analytical Methods

In order to accurately assess the quality of drugs, reliable, sensitive, and specific analytical methods must be developed. These analytical methods should undergo comprehensive validation, including the evaluation of specificity, linearity, precision, accuracy, detection limit, and quantification limit. The validation process should comply with regulatory requirements and industry guidelines.

Why Choose Us for Nucleic Acid Drugs Quality Control Services?

• Complete Instrument Resources
  First-class large-scale precision instruments, such as single crystal diffractometers, NMR, GC-MS/MS, LC-MS, ICP-MS, and IC, provide a wide range of options for comprehensive product research.
• Deep Professional Accumulation
  We have been committed to drug development, production, and research for many years. We can provide customers with more professional and suitable solutions for drug quality research.
• High-quality Services
  We excel at overcoming challenges and offer customers comprehensive one-stop services. Our team includes professional Quality Control (QC) and Quality Assurance (QA) experts, as well as senior synthesis technology specialists, ensuring efficient service to meet various customer requirements.
• Perfect Quality Management Systems
  For various customers, we rely on the management system to ensure the authenticity, completeness, reliability, and traceability of data and information, and to comply with regulatory requirements. We support customer audits and collaborate with official verifications.

Relying on advanced instrumentation, rigorous experimental procedures, and an elite team of senior material scientists, chemical analysts, and technicians, CD Formulation's laboratory is dedicated to the quality control of nucleic acid drug products and provides accurate and authoritative composition analysis services. Contact us for customized solutions.