Method Validation and Stability Analysis of Nucleic Acid Drug
Creative Biolabs provides a full range of analysis and testing services from nucleic acid product development to commercialization, utilizing a variety of in vitro method, in vivo method, molecular biology, analytical chemistry and precision instrumental analysis methods to guide the design of testing programs and quality standards recognized by regulatory agencies worldwide.
Creative Biolabs has been committed to method validation and stability analysis of nucleic acid drug services for many years. With rich development experience, world-class team and project process in compliance with regulatory requirements, Creative Biolabs successfully helps customers to conduct multiple method validation and stability analysis services.
Services We Can Provide:
1. The development, certification and validation of analytical methodology.
- Creative Biolabs helps customers develop and validate the method of raw material selection
- Creative Biolabs can assist customers to develop the analytical methodology of preparation production processes and verify the effectiveness and feasibility of the methodology.
- Creative Biolabs can assist customers to establish batch release standard parameters, determining the analytical methodology of product release.
- Creative Biolabs helps customers develop and validate the method of drug stability.
2. Validation of analysis methods.
According to customer requirements, Creative Biolabs develops various methods for different oligonucleotide products, including methods of product purity, related substances, moisture, elemental impurities, sodium salts, residual solvents, content, microbial limit and bacterial endotoxin. Creative Biolabs performs methodological validation of the developed analysis method to ensure that it truly meets the requirements for nucleotide and its drug detection and quality control. Creative Biolabs transfers the method to the customer according to pharmacopoeia requirements and further optimizes and validates it.
3. Drug stability analysis service.
Creative Biolabs provides customers with a full range of stability analysis services, including influence factor test, accelerated stability test and long-term stability test. According to the environment of product use, packaging, storage and transportation, Creative Biolabs strictly follows the guidelines of all levels, such as ICH Q1A (R2) and Chinese Pharmacopoeia 2015 edition, to provide comprehensive stability analysis services for customers.
4. Study schedule service.
Creative Biolabs can provide a complete schedule of experiments.
- Conduct conditional test, accelerated test and long - term test.
- Accelerated stability test. This service includes 1 environmental condition and 6 months trial period.
- Long-term stability test. This service includes 1 environmental condition and 36 month trial period.
- Examine the effects of coercive conditions. Creative Biolabs can assist customers to study the effects of light, high temperature, high humidity, acid, alkali, oxidation and other conditions on sample decomposition, moisture, maximum single impurity, total impurity, and content change.
5. Packaging material analysis and verification.
The internal and external packaging materials of drugs are widely used in the field of drug production. As a direct contact of medicine, its quality is directly related to the safety of medicine. Microbial load is one of the main sources of environmental microbial pollution in drug production. The packaging material analysis and verification service of Creative Biolabs is very necessary.
Thank you for choosing our service of analysis method and stability. If you have any questions, please contact our staff, we will answer and serve you immediately.
*For Research Use Only. Not for use in diagnostic procedures.