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.
Single-use bioreactors are increasingly used in research, process development, and production. Like conventional reusable systems they have to allow the setup of optimal growth conditions. A sufficient supply of oxygen is crucial for aerobic bioprocesses, and the velocity of oxygen entry into the culture medium is often described by the volumetric mass transfer coefficient (kLa). Because single-use bioreactors offered by different manufacturers vary in parameters critical for oxygen transfer—like mixing, power input, and gassing strategies—they are often not directly comparable to each other and to conventional glass and stainless steel vessels. Even kLa values experimentally determined by the manufacturer or users are not necessarily comparable, because the results might differ dependent on the method used.
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.