Newsletter | November 10, 2021

11.10.21 -- Balancing Speed And Customization In Testing Approaches

 
Envisioning The Future Of Analytical Development For Gene Therapies
 

Explore how safety and characterization testing of viral vector production differs from that of other biologics and how novel analytical approaches are being tailored to these advanced therapeutics.

Unveiling The Potential Of Your AAV Gene Therapy: Orthogonal Methods To Understand And Define CQAs
 

As with all biopharmaceuticals, it is important to identify and monitor the critical quality attributes (CQAs) of products based on adeno-associated virus (AAV) to ensure their safety and efficacy. In this webinar, experts present a range of orthogonal methods to understand and define the CQAs of AAV products.

Application Of Two-Dimensional Chromatography To Improve Productivity Of Analytical Testing Of Cell And Gene Therapy Products
 

In this video, we present a proof-of-concept work demonstrating application of multidimensional chromatography for characterization of Adenovirus type 5 (Ad5)-based product that not only allowed increased productivity but also limited the sample volume needed for the analysis.

Unlocking The Potential Of Viral Vectors Through Functional Titer Assays
 

This poster reviews two virus-based gene delivery platforms — AAV and lentivirus (LV) — focusing on the development, validation, and implementation of titration methods used to measure functional titers.

Implementation Of Rapid Test Methods In Cell And Gene Therapy Testing
 

Rapid testing methods for sterility, mycoplasma, and replication competent lentivirus of cell and gene therapies can help address critical issues within this rapidly growing area of the market.

Biosafety In Gene Therapy: Applying The Latest Regulatory Guidance For RCL Testing
 

For lentivirus-based therapies, generation of replication competent particles is a potential risk as a result of biosafety and quality. While improvements in design and manufacturing have decreased the probability of producing replication competent viruses, regulatory agencies provide guidelines to test for their presence at multiple stages in production.

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AAV Biosafety Testing And Characterization Services

Biosafety testing and characterization for new products is essential as they emerge for clinical study. Both measures will help mitigate safety concerns and confirm product quality before these therapies are administered to patients. Our BioReliance® AAV testing services give you the confidence to get your products to market quickly and safely.

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