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GEN Protocols

Analytical Testing

Protocol

Radiolabelling Nucleic Acids with [γ-32P] ATP for Analytical Assays

Nucleic acids are readily modified with tags that enable detection, purification, or tracking their interactions with other molecules. One of the standard labels used to generate nucleic acid probes includes radioactive phosphates because they allow for sensitive and rapid detection. This protocol d... More


Protocol

USP Compendial Particle Measurements with the Aura System

The Aura platform provides a rapid and robust USP 788 compendial method for subvisible particle analysis, a critical quality attribute. It can handle a wide range of sample types and can analyze anywhere from 5 µL to 10 mL of sample, enabling continuity of method from developability assessment to lo... More


Protocol

USP Particle Count Standards with Aura and Particle Vue 3.1

All membrane microscopy methods must generate accurate and reproducible counts for bead counting standards. We present a validated methodology for accurately counting United States Pharmacopeia (USP) microsphere count standards on Aura systems by seamlessly calculating the cumulative area of all the... More


Protocol

Evaluate Cell Therapy Product Purity with Aura CL

The CAR-T development workflow is a multi-step process that includes transfection of T cells with a viral vector to express a chimeric antigen and activation/expansion of the CAR-T using a molecule like a Dynabead conjugated to CD3/CD28. Each of these steps is a potential source of contamination tha... More


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


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