Newsletter | May 29, 2025

05.29.25 -- Enhance Safety In Cell And Gene Therapies

Using Next Generation Sequencing To Test Raw Materials

When biopharmaceutical products are manufactured using reagents derived from animal sources, there is an inherent risk of introducing viral contaminants into the production process. Explore the use of Next Generation Sequencing to proactively screen raw materials, which aims to reduce viral contamination risks.

Replacement Of Traditional Adventitious Virus Testing

For several decades, molecular-based technologies have played a crucial role in evaluating viral safety in biologically derived samples. Discover how these technologies, including PCR and Next Generation Sequencing, are transforming viral safety testing by offering broader, more effective alternatives to traditional animal-based methods.

Purity As A Priority: Optimizing Safety Measures For rAAV Therapies

Recombinant Adeno-Associated Virus (rAAV) vectors are increasingly utilized in vivo gene therapy. Watch to learn how rAAV vectors in gene therapy address manufacturing impurities, risks to patient safety, and analytical methods for detection while aiding sponsors in compliance.

Viral Clearance Considerations For Adeno-Associated Virus (AAV) Vectors

Viral clearance studies for non-enveloped viral vectors have been performed less frequently than those of enveloped viral vectors. For this reason, the virus inactivation steps and the model virus panel for clearance studies may not be as clear. Gain a better understanding of viral clearance studies for AAV vectors.