02.03.23 -- Sterility Test Method Considerations When Working With CDMOs

Spray-dried dispersions, hot-melt extrusion, and solubilizing excipients are common solubility enhancement techniques, but new developments to maximize amorphous solid dispersion benefits are needed.

The manufacture of sterile injectables is fraught with risk, especially when it comes to protein aggregation in biologic drugs. We offer steps you can take to help prevent aggregation.

Just-in-time monitoring can offer companies a reliable, cost-effective means of tracking a shipment’s temperature fluctuations in transit, allowing for usable regulatory data that can inform subsequent shipping strategy.

Due to the high potency of APIs, machine operators must be protected. Yet, humans are a high source of product contamination. In pharma manufacturing facilities, isolators are becoming increasingly important.

Learn about solutions that remove packaging complexity from the blister line and allow it to operate with significantly improved utilization of the assets and operational effectiveness.

In cleanrooms and other critical environments, proper wiping technique plays an important role in reliable and consistent contamination control. Learn about the proper technique for contamination removal.

Aside from level of shear or 'gentleness,' other factors help determine which type of blender will work best in certain applications. Following are some things to consider when choosing your blender.

Speed plays an important role in gene therapy and being first to market is essential for most gene therapies. Learn how you can benefit from an integrated approach.

Explore different pollution-contributing factors in biochemical manufacturing, spatial considerations when comparing disposable to traditional systems, and current environmental-based initiatives.

We explain how to successfully address common process development challenges to achieve an efficient journey to market and maximize the biotherapeutic’s potential impact.

Explore the further development of a two-step purification of a bispecific antibody (bsAb) in a collaborative study to develop a downstream process.

Understand the difference between a validated sterile claim and a low or zero bioburden microbial control claim on single-use systems and where each fits into biopharmaceutical manufacturing processes.

This article explains the use of Lyobead technology in the diagnostic and pharmaceutical sectors and describes how these beads have been used for different applications.

Partnering with a CDMO proficient in green chemistry and manufacturing can help a biotech create the most attractive drug package — one that includes a proven commercialization process minimizing toxic wastes that pose safety concerns or require costly remediation.

This application note details a complete workflow of a middle-up mass analysis of protease digested Cetuximab monoclonal antibody, starting with the antibody purification, proteolysis and reduction to its reversed phase UHPLC-MS analysis.

During QC testing, a number of vials of liquid vaccine product stored at -80 °C were found to have an overpressure, representing a serious safety risk. They needed to identify the root cause.

Practical information on key issues including extractable/leachable testing in components, freeze/thaw in single-use assemblies, efficiencies driven by SUT advances such aa genderless connectors, and more.