Securing Supply In Single-Use Systems: The Second-Source Decision By Wayne Koberstein, Charter Medical
The use of disposable systems for bioprocessing manufacturing has become a viable and cost-effective way for many pharmaceutical manufacturers to handle bioproduction requirements during clinical trials of drug candidates. A company's reliance on such systems also comes with a stronger tie to the suppliers of single-use systems and components, because only products qualified for use and validated in the process can be used in production. What happens if the supplier cannot deliver?
The Drug Delivery and Formulation America Summit 2012 will address the latest strategies and research and development needed to succeed in this evolving area. Topic areas include:
• Pharmaceutical Formulation and Delivery — enhancing solubility and bioavailability
• Biologic Formulation and Delivery — improving stability and preventing aggregation
• Collaborative Partnerships — evaluating potential of new drug delivery technologies Learn more.
Spotlight On Cell Culture
Cells Disruption By Means Of High-Pressure Homogenization
After the fermentation of cells, the culture is processed to separate the cells, by means of a speed centrifuge in order to concentrate them. The collected cells are resuspended with a buffer in order to prepare them for the next unit operation, the high-pressure homogenization used in order to obtain the cells disruption.
Using Freeze-Drying Microscopes (FDM) To Improve Cycles
A customer approached BTL with a product that was being freeze dried using a generic cycle (which was applied to a number of other products). It was failing to meet the required moisture threshold (no more than 2%) and each batch was therefore rejected.
In this 60-minute webinar and Q & A session two panelists, Jim Lambert from Genentech and Rick Johnston, Ph.D., from Bio-G, will present their perspectives on Quality by Design (QbD), and answer questions about the implementation of QbD in biopharmaceutical manufacturing.
UPS puts the power of logistics to work for you to help safeguard your temperature-sensitive air freight shipments with an end-to-end system that delivers worldwide. UPS Temperature True® is specifically designed to safeguard temperature-sensitive shipments, providing 24/7 monitoring to help keep your shipments within strict temperature tolerance.