02.09.24 -- Drug Labeling: 3 Pitfalls To Avoid And 8 Best Practices To Follow

Validated processing methods and storage conditions are the first steps toward providing a safe and effective product for transplant. Review a retrospective analysis of a final verification process.

Review the details of an optimized transient expression system that offers a ‘hybrid’ approach for boosting titers of a wide range of molecules.

Learn what Annex 1 has to say about viable and nonviable environmental monitoring, room classification, qualification, risk assessment, and more.

Optimize purification steps and determine with confidence whether process steps and parameters are effective before investing resources in regulatory supporting validation studies using live virus.

Biopharmaceutical manufacturers are exploring a single-use solution for bioreactor maintenance that can reduce the labor, time, and risk of contamination associated with traditional bioreactors.

Learn how a stage-gate approach to technology transfer and biomanufacturing can help to mitigate risk while shortening cycle times throughout the project life cycle.

Every choice is critical in AAV vector production. Experts share how to make the right choices, from the process and cell line to off-the-shelf plasmids and qualified analytical methods.

Tailored CMC services can lead to shorter global licensing timelines and minimize variability in globally registered product details.

To optimize and standardize cell line development that benefits downstream work, organizations must focus on technology and expertise in three key areas: automation, analytics, and digitalization.

Early planning for scale-up and biologics license application activities can maximize your chances of success by allowing sufficient time to develop launch options and prevent costly delays and setbacks.

Explore results from a resin lifetime study with over 150 cycles, using clarified cell harvest in every cycle, which has been performed to evaluate the alkaline stability of three protein A resins.

Take an in-depth look at a capture device designed to scale consistently by residence time.

The experience and expertise of the CMO is crucial to avoid the risk of cross-contamination of the drug product, as failures or weaknesses in this process can pose risk to the end user.

Explore a fill system designed to automate product draining and recovery within a batch to standardize processes and minimize nonrecoverable hold-up within the filtration and distribution flow path sections.