Sponsored by: GE Healthcare Life Sciences
Session ends: November 1st, 2013, 3:00pm MST
Answers by: Patrick Guertin, Senior Manager, Upstream Process Development and Pilot Plant, Xcellerex, now part of GE Healthcare Life Sciences
Xcellerex XDR single-use, stirred-tank bioreactors are well-characterized systems that deliver a performance comparable with that of conventional bioreactors from process development to manufacturing scale. The technology has been successfully used in a variety of different applications including mammalian suspension cell culture, microbial fermentation and cultivation of adherent cells using microcarriers.
Hosted by Patrick Guertin, Senior Manager, Upstream Process Development and Pilot Plant, Xcellerex, now part of GE Healthcare Life Sciences. Mr. Guertin has 25 years of experience and significant expertise in upstream process development, pilot plant operations and cGMP manufacturing for recombinant therapeutics, monoclonal antibodies and vaccines. His skill set also includes process optimization and scale-up and down procedures in microcarrier, fed-batch and perfusion modes.
Questions & Answers
A high quality sparge element with consistent pore sizes is a key feature. There are a few aspects to consider. It could be the inconsistent bubble size, but it could also be a specific sub-set or particular bubble size that is having an impact on the cell health. The range or variations of sparge element […]» Read MoreTo date, we have not seen an issue with cell growth in Xcellerex products. Nevertheless, we have initiated efforts to interface with raw-material suppliers to better understand actions that might need to be taken to manage the specific issue that you have mentioned. These efforts are part of a larger mission to manage the overall […]» Read MoreYou are correct, the 2000 L single-use system is the largest available at this time. However, we believe the Xcellerex platform technology is capable of larger sizes/volumes, but we have not seen a market demand for it. This is likely a result of increased titers or higher producing cell lines in conjunction with perfusion and/or […]» Read MoreThe XDR reactor can be and is currently used in perfusion processes and there are a variety of perfusion systems that can be applied. There are a couple of features that should be remembered for this application. The first one is the connections between the perfusion apparatus to the bioreactor, specifically draw and return. Aseptic […]» Read MoreOne of the first steps is to establish a reliable scale-down model in the bench-top reactors. We have used the XDR-10 in the scale-down mode to design and predict what we will see in the large scale systems. The control methods and hardware are critical. Special attention should be given to the dissolved gasses, both […]» Read MoreThe amount or level of training will depend on the relative skill level of the operator on the stainless steel system. For example: The controller on the Xcellerex™ XDR system has various levels of access and capability. If an individual will be taking readings and monitoring the system, this will require less training compared to […]» Read MoreXcellerex GE Healthcare Life Sciences has an in depth analysis outlining this model. Some brief examples include the following: Savings are a result of time savings (system prep, system turnaround, labor) and infrastructure savings. Single-use bioreactor bags come gamma-irradiated, therefore you don’t need to perform steam in place (SIP) sterilization operations as with traditional systems. […]» Read MoreThis would begin with an understanding of the cells and the microcarriers you choose to examine. Preliminary studies in spinner flasks are most often a prelude to a bioreactor application. Keep in mind that the choice of microcarrier bead is critical. The specific gravity and diameter of the bead is an important aspect to scaling-up […]» Read MoreOne of the key components for single-use system manufacturing is the system’s ability to control the critical process parameters such as dissolved oxygen (D.O.), pH, temperature and agitation within your desired target range. Then, what are the appropriate or optimal control strategies that will achieve these critical process parameters. Dissolved oxygen for example: select a […]» Read More