ID & Assay
Identification (ID) testing is one of the most crucial elements of cGMP supply chain.
ID Testing ensures that the correct drug substance (API) is used in the correct product. Thus, ID testing is performed on both the drug substance and drug product. This testing is not required on stability samples to establish shelf life.
At Vici, we use two orthogonal techniques to establish the ID of the drug substance and drug product. The most common approach is to use High-Performance Liquid Chromatography (HPLC) for ID testing. This testing data is generated in our quality control lab (QC lab), approved by our quality assurance (QA) department, then recorded into a Certificate of Analysis (COA).
Potency Assay Testing
Vici develops stability-indicating potency assay methods, per FDA requirements, to support cGMP manufacturing and testing. Potency assay testing is performed on the active pharmaceutical ingredient (API) or drug substance, drug product, and special ingredients such as preservatives and other ingredients with a label claim. Vici utilizes state-of-the-art HPLCs to offer HPLC-based impurity and related substances method development, validation, and testing using the following:
- HPLC UV detectors
- HPLC PDA detectors (photo diode array)
- HPLC RI detectors (refractive index)
- Ion chromatography (Dionex system) to detect ions that do not have chromophores for UV detection
Vici also uses ICH stability chambers to perform necessary product shelf-life studies and testing for both clinical trial material and commercial supplies.
Assay Method Development & Validation
Assay method development is typically based on compendial methods or methods provided by the drug substance vendor. If such methods are not available, Vici’s experts can develop de novo analytical methods.
Drug Product Assay Method Development & Validation
Vici is experienced and has perfected the technique in developing reliable, accurate assay methods for pharmaceutical products. For assay method development, the active ingredient must be fully extracted from the dosage form containing inactive ingredients, which can prove challenging for drug products containing extended-release excipients. Contact us today to see how we can help you with your analytical testing needs.