The loss of product as a result of bag failure isn’t just an annoyance; it’s an expense, and a costly one at that. However, Chuck Hart, director of manufacturing at Prolong Pharmaceuticals, says with proper fitting and handling, these concerns can be mitigated.
The Standardized Extractables Testing Protocol For Single-Use Systems In Biomanufacturing written by BPOG members last year establishes a foundation from which to create a standardized approach to extractables testing. However, since its release, there have been some questions and discussions about how to effectively implement the protocol.
The data from BioPlan Associates’ 12th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production speaks to the industry’s ongoing desires for standardization in single-use devices. As usage of these disposable devices increases, the gap between the importance of standardization and end-users’ satisfaction with their supplier’s standardization efforts has steadily been worsening.
Drug manufacturers today are increasingly demanding flexibility in their manufacturing processes. So who better to provide those solutions than someone who has spent her career dealing with change.
Because single use bioreactors offered by manufacturers vary in parameters critical for oxygen transfer, they are often not comparable to each other and to conventional glass and stainless steel vessels.
The packed-bed basket technology, developed by New Brunswick Scientific (acquired by Eppendorf Inc. in 2007), provides a shear free environment for production of animal cells. At present, little information is available on the utility of the New Brunswick CelliGen® BLU singleuse bioreactor system for the production of secreted proteins, especially in perfusion mode of operation.
The objective of this study was to compare Eppendorf BioBLU single-use packed-bed bioreactor vessel and the traditional glass vessel counterpart used in New Brunswick™ CelliGen® 310. Alkaline phosphatase (ALKP)- secreting Chinese Hamster ovary (CHO) cells were used to measure ALKP production in each bioreactor.
Silicone rubber is widely used in the pharmaceutical industry where sterilizability is an essential requirement for all fluid transfer equipment. Pharmaceutical products must be sterilized frequently and repeatedly by high level energy and/or chemical vapor in order to eliminate bacterial surface contamination.
SAFC’s CHOZN® Platform has been developed as a ‘plug and play’ manufacturing system for the creation of biopharmaceutical producing cell lines.
Zinc finger nucleases (ZFNs) have proven to be a powerful tool for modifying genes. In comparison to traditional techniques, such as adding chemical or radiation based mutagens that cause various random mutations, ZFNs can create very accurate, targeted changes to the genome in a much more rapid fashion.
DSM Pharmaceutical Products, the custom manufacturing and technology business of Royal DSM (NYSE, Euronext: DSM KON), announced today that it has signed a non-exclusive license agreement with Amgen Inc. for access to DSM's proprietary XD® high cell density process patents.
GBI Research, the leading business intelligence provider, has released its latest research "Cell Culture - Rising Demand for Biologics and Growing Visibility of Approval Pathway for Biosimilars will Create Growth Opportunities", which provides in-depth analysis on the processes, drivers and barriers of the cell culture market.