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 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.
Broad adoption awaits fully scalable GMP systems, improved and less costly disposables, better analytics, greater process automation and low-shear mixing.