03.07.25 -- Knowledge Management In Biopharmaceutical Development

Empty capsids in AAV preparations can reduce efficacy and trigger unwanted immune responses. Droplet Digital PCR offers a fast, precise, and easy way to quantify empty and full capsids in AAV samples.

You have designed your flow cytometry panel for cell manufacturing and patient monitoring. Now what? Use this journey map to help ensure optimal resolution of your populations of interest.

Membrane proteins are vital for drug discovery, but traditional techniques can disrupt their structure. This study showcases a new method that maintains native conformation during analysis.

Finding partners with the necessary skills to optimize AAV processes is crucial for minimizing risk. Explore key considerations for advancing your therapy from concept to commercialization.

A facility monitoring system is a process monitoring tool that collects data from sensors such as optical particle counters, differential pressure sensors, and temperature probes in real time.

Consider these strategies for meeting quality and regulatory requirements in cell and gene therapies that can also help to identify issues early, reduce risks, and prevent delays and rework.

Testing and selecting an aqueous cleaning system involves a seven-step process. Follow along as we walk through those steps to help you optimize your cleaning process.

Learn about the changes introduced in the latest revision to EU GMP Annex 1, and gain insight into the components that should be part of a PUPSIT risk assessment.

The FDA recommends an approach to computer system validation called Computer Software Assurance. Explore insights to help you understand CSA and how to implement it in your organization.