Advanced Therapy Medicinal Products are revolutionizing treatment for severe diseases, but ensuring their safety before administration remains complex. Traditional Mycoplasma testing methods can delay ...

In January 2024, the FDA updated its guidance on CAR-T therapies, emphasizing the need for enhanced safety and quality measures. This update followed a series of warnings regarding the risk of T cell ...

Like traditional biologics, cell and gene therapies (CGTs) must meet safety and efficacy standards before they can be administered to human patients. But the manufacturing processes used for this new ...

The most common method for evaluating replication competency of lentivirus and AAV vectors is through serial passaging of virus in cell culture lines and subsequent identification of viral particles ...

Abstract: Medical technologists are integral to public health, providing critical expertise in drug testing and blood banking. This article explores their role in ensuring accurate testing, ...