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Protocol
Detect Specific Protein Aggregates in Biologic Formulations with the Aura Immunoassay
Biologic co-formulations target multiple pharmacologically active sites to increase therapy efficacy. However, either biologic can be a source of protein aggregation that can negatively influence the product’s safety, efficacy, and therapy. Aura systems are the only particle analyzer that can pinpoi... More
Protocol
How to Determine Glycan Profiles of Biopharmaceuticals from Peptide Mapping Data
Glycosylation is a common critical quality attribute (CQA) of therapeutic proteins and needs to be characterized during product development. Typically, this analysis is conducted after enzymatic release and tagging of the glycans followed by fluorescence and MS detection. However, that approach lose... More
Protocol
Skin Freezing Technique for Living Cell Bank
Cell banks are especially important sources of studies for which living cells are needed, as well as a repository of genetic diversity in natural populations. We propose a simple protocol for field research that can maintain viable skin cells for in vitro replication and production of fibroblast lin... More
Protocol
A Protocol for Qualifying DNA Variants Associated with Complex Diseases like Ehlers-Danlos syndrome
A protocol for DNA variant qualification adds medical perspective to consensus grading based on impact of the DNA change on its encoded RNA/protein and its prevalence in normal people versus those with the implicated disease. This clinically familiar 1-4+ qualification can encourage physician accept... More
Annual Guide
