Validation & Quality
Environment, Methods, Materials and Validation
RiboBio’s cGMP manufacturing facility meets or exceeds current IS08, IS07 and IS05 requirements as well as ICH Q7(cGMP) and CFDA Title 21 part 210(cGMP) requirements. To ensure RiboBio continues to meet or exceed these requirements, RiboBio conducts continuous and systematic on-going testing of facilities, water and air supplies, major equipment and in-coming raw materials.
• Validated procedures for the strict qualification of raw materials from reliable, industry-leading suppliers
• Centralized gas supply with on-site purification systems for air and water
• Operating procedures for equipment cleaning, sanitization and validation.
● Establishment and formulation of product quality standards
Establish and develop new drug quality standards from the safety and efficacy of drugs, the safety of impurities, batches of process development and existing testing technologies.
● Finished product sequence verification
Sequence verification is critical to the quality of nucleic acid drugs. We have a leading LC-MS platform and a powerful analysis software to ensure better detection resolution, sensitivity, dynamic range and experienced personnel to provide drug sequence verification services. The sequences are available for oligo-conjugated cholesterol, various linkers, modified or restricted bases, sugar modifications, and mixtures.
● Solvent residue analysis and test
We test the organic solvent in the production of oligonucleotide products that not completely removed during the process, and verify the residual solvent method to ensure that the set limits and development methods are in line with product specifications and GMP requirements.
● Element impurity analysis
According to the ICH Element Impurity Guide and the USP standard, we conduct suitable verification for corresponding requirement to detect the elemental impurity in oligonucleotide products.
● Anion and cation analysis and test
We provide detection services for potential inorganic anions, inorganic cations, and partially polar organics in oligonucleotide products.
● Water Detection
We provide water testing service for oligonucleotide products.
● Analysis and detection of microorganisms and endotoxins
We provide testing services of drug microbial limits and bacterial endotoxin, in addition to providing method validation services.