04.17.26 -- From Pandemic Collaboration To Patent Litigation: BioNTech's Case Against Moderna

Maintaining facility integrity during downtime requires rigorous protocols. Discover essential strategies for cleanroom sanitation, environmental monitoring, and effective restart procedures.

Teams face rising pressure around compliance, complexity, and speed. These five essential qualities help identify packaging partners who can support production, reduce risk, and align with your needs.

Learn about the process conditions and protocols that were chosen as optimization targets and the resulting improvements to ADC production and purification that assessing these parameters provided.

Accurate, readable pharmaceutical labels are crucial. See how to navigate considerations like printing, application tolerances, and inspection to select the right machinery for your production environment.

This disposable pen for Semaglutide is a generic drug-device combination, designed for usability and regulatory compliance, showing comparable performance to the reference device.

Here, two of the more common methods for container closure integrity testing, high voltage leak detection (HVLD) and vacuum decay, are compared.

Navigating PFS selection requires balancing complex regulatory requirements and supply chain logistics. Adopting an integrated system approach provides unified data and streamlined documentation.

Effective CCIT goes beyond micron claims, focusing instead on repeatability, confidence, and real‑world relevance. Examine how to define a defensible LOD and understand what auditors truly prioritize.

Residual host-cell DNA quantitation requires sensitive, well-validated analytical workflows to ensure accurate impurity control, process understanding, and regulatory compliance in complex biologics.

Explore a modular approach to Pharma 4.0 that empowers organizations to embrace digital transformation at their own pace and is tailored to their unique needs.

Manual processes in CMC development create costly delays and compliance risks. Find out how digitization can eliminate bottlenecks, improve traceability, and accelerate timelines.

A sponsor’s commitment to rigorous impurity control throughout manufacturing is vital to ensuring patient safety. E&Ls, nitrosamines, and PFAS are among the most critical impurities to test for.