Analytical Testing
Analytical Testing
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
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
Protocol
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
Protocol
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
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
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