Data integrity problems in pharmaceutical quality control laboratories are driving more regulatory action than ever before. It is obvious that something has changed to drive all this activity. There is plenty of information available, but much of it seems to confuse or frustrate rather than clarify or help. In this summary, we will provide clarity, dispelling confusion by looking at the facts, based on a study of available resources and direct interactions with FDA staff and their consultants. You’ll learn from Loren Smith, Agilent’s software compliance expert and a UC Berkeley instructor with 25 years of regulated software experience, how to put the current enforcement environment in historical context, and to apply critical thinking skills to what you hear or read regarding data integrity. You’ll also learn how to evaluate your current laboratory software and associated processes against these new expectations, as well as how vendors are redesigning laboratory software to help you respond to these new realities.
Mitigating High Sample Volume Consumption in AAV Aggregate Analysis Using a Biozen™ dSEC-7 by SEC-FL
April 15th 2024This application note showcases a Biozen dSEC-7 SEC chemistry/fluorescence detector solution, offering reliable AAV aggregate analysis in under 10 minutes with as little as 0.5 µL of sample. Across four AAV serotypes, resolution between monomer and aggregates remains consistently high, emphasizing Biozen dSEC-7's efficiency and ability to maintain accurate detection at minimal injection volumes. Ideal for routine testing, this solution ensures precise measurement of a CQA with streamlined sample consumption.
Adeno-Associated Virus (AAV) Serotype Screen Using a Biozen™ dSEC-7 Size Exclusion Column
April 15th 2024With its 700 Å large pore silica particle and hydrophilic diol-type surface chemistry, Biozen dSEC-7 provides excellent resolution of monomer from dimer peaks in under 8 minutes across four different AAV serotypes. This capability is crucial for optimizing gene therapy biopharmaceuticals, ensuring thorough analytical scrutiny to select the most appropriate serotype(s) for enhanced therapeutic outcomes and immunogenic profiles.