Formulation and establishment of quality standards
Quality standards run through the entire drug lifecycle from discovery through clinical to commercial. Our experienced quality research team can develop scientific and reasonable quality standards of raw materials, working reference standards, intermediate products and products，based on the requirements of our partners, laws and regulations. Systematic, in-depth, and comprehensive research on product quality during R&D and manufacturing processes will support the formulation of final quality standards and meet the needs of IND, NDA applications.
Raw material test
We test and release each batch of raw materials used for manufacturing according to quality standards, ensuring effective control of the source and quality of the materials, and providing guarantee for product quality.
In-process quality control
Ribobay has established manufacturing in-processing control projects for oligonucleotide synthesis, ammonolysis, purification, ultrafiltration, and annealing, timely and accurate comprehensive quality control of each process step, ensure the controllability of product quality.
Quality Test
The QC team of Ribobay strictly tests the products in accordance with quality standards and analytical methods, and provide corresponding COA.To timely report the occurrence of OOS and OOT during the testing process, investigate and analyze the reasons, and ensure the compliance and traceability of the testing process. For the receipt and retention of samples, we have storage conditions with different temperature and environmental requirements. The EMS system monitors the temperature and humidity data in real time. Handle the situations that arise during the monitoring process timely to ensure the storage conditions of the sample, the authenticity and integrity of the data.
Impurities study
Study the organic impurities, inorganic impurities, residual solvents and genetoxic impurities in oligonucleotide products, and confirm the source, type and limitation of impurities to ensure the safety and effectiveness of products.
Structure characterization of API
The structure and physicochemical properties of the samples should be confirmed by using NMR, MS, UV, IR and other testing instruments to ensure the accuracy of the sample structure.
Stability study
We are equipped with stability test chambers with different temperature and humidity requirements, which meet ICH Q1A and related regulations for the stability test of different temperature and humidity requirements such as influencing factor test, long-term, accelerated and intermediate conditions. Temperature and humidity data is synchronized into EMS system, ensuring the integrity of the data, for the product packaging, transportation, storage and validity to provide adequate basis, and to provide comprehensive stability study services for our customers.
| Stress testing | High temperature test (40℃) |
| High humidity test (75%±5%) | |
| Photostability testing by strong light (4500lx±500lx) | |
| Accelerated(25±2℃, RH60±5％, 6 months) | |
| Long term(24 months) | -20℃ |
| 5±3℃ | |
Preparation and calibration of reference standards
When there is no official reference standards such as BP, USP or EP, Ribobay can provide a solution for your reference standards needs. Through the preparation and calibration of APIs and impurities, working reference standards for identification, inspection and assay can be obtained.
