Scorpius offers a comprehensive range of cGMP biologics analytical testing services to support biomanufacturing. Existing bioanalytical methods can be tech transferred and/or custom methods can be developed in-house. Analytical test methods used for product characterization and QC release testing are qualified or validated to meet the specific needs of the client and cGMP regulatory requirements.
Scorpius employs a “phase-appropriate” approach to method development, qualification, and validation. As part of method development, key performance criteria such as accuracy, precision, linearity, specificity, system suitability, etc., are evaluated. These development data serve as a baseline for subsequent protocol-driven qualification and/or validation studies.
Scorpius performs method qualification of non-compendial product-specific methods to demonstrate their suitability for use in product characterization, QC release, and stability testing of drug substance and drug product intended for Phase I/II clinical studies. We recommend that full method validation be performed prior to utilizing methods during process validation, conformance lot manufacture, and characterization and QC release testing of drug substance and drug product for Phase III clinical studies. Tables A, B, C and D below show typical characterization and QC release tests for mammalian and microbial cell banks, cell therapy final cell product, protein therapeutics and plasmid DNA product.