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GEN Protocols

Analytical Testing


AAV Aggregate Quantitation and Identification with the Aura System

Adeno-associated viruses (AAVs) have made the promise of gene therapy a reality by enabling safe, targeted delivery of curative genetic payloads. The formation of aggregated viral vector is an important critical quality attribute to measure because they lead to adverse immunogenic events and are an ... More


High-Throughput Detection of Degraded Polysorbate in Biological Formulations with FMM

Excipients like polysorbate are used in the majority of biologic products to improve stability. However, the polysorbate itself can degrade, impairing the stability of the API and contributing an additional aggregate source that can elicit an immunogenic response. Traditionally, monitoring only poly... More


Protein Aggregate Identification with FMM: Rapidly Distinguish Protein from Non-Protein Particles in Biologic Formulations

Don’t rely on unreliable morphology characteristics or refractive index to determine if particles in your formulation are protein or non-protein. Aura systems are the only particle analyzer that combines fluorescence membrane microscopy (FMM) with backgrounded membrane image (BMI) to give you defini... More


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


Performing a manual run on your Xuri™ Cell Expansion System W25

The purpose of this protocol is to provide instructions on how to perform a manual run on the Xuri™ Cell Expansion System W25 using UNICORN™ software.This protocol applies to anyone performing a manual run on the Xuri™ Cell Expansion System W25.... More

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