Although the T-175, and its other sized siblings, are tried-and-true workhorses of the cell culture bench, they offer limited options when you want to scale-up.* In most cases, researchers will increase the number of flasks they seed, which results in more handling, more processing time, and the need for more incubator space.
Which is what makes the Corning High Yielding Performance Cell Culture Vessel (Corning® HYPERFlask®) cell culture vessel such an innovative solution. Using a proprietary multi-layered gas permeable growing surface to provide efficient gas exchange, Corning HYPERFlask vessels offer 10 times the growth area (1,720 cm2) while taking up the same incubator space as a 175 cm2 flask.
Cells attach and grow on the gas permeable material with gas exchange occurring through the film layer. All fluid manipulations occur through the single neck, which is contiguous with all the layers.
In addition, Corning HYPERFlask vessels utilize the same gas permeable growing surface as Corning HYPERStack® cell culture vessels, which provide cell growth areas from 6,000 cm2 (12-stack) to 18,000 cm2 (36-stack) in a compact footprint. This makes the HYPER family a reliable scale-up path from research to bioprocessing.
Scaling-up for Clinical Trials Using HYPER Technology
In their Phase I trial, researchers at the Ottawa Hospital Research Institute’s Cell Manufacturing Facility dosed freshly cultured allogeneic bone marrow-derived MSCs into patients with septic shock.1 A single dose was manufactured using the Corning HYPERFlask on an as-needed basis. Since dosing was developed on an emergent per-patient basis, researchers were notified of a patient enrollment and had to deliver the dose within 6 hours.
When larger-phase clinical trials were needed to determine true clinical impact, researchers needed to be able to work within the same isolator units, following the same protocol, with successful, reproducible cell culture on a much larger scale.
“Hospital-based cell manufacturing facilities often have significant space and staffing constraints making the more standard scale-up process difficult to accomplish. The Corning HYPERStack system provides a much more manageable platform to reach batch production levels appropriate for the typical scale up required in academic trials with MSCs,” said Dr. David Courtman, Director Biotherapeutics at the cell manufacturing facility.
Using the Corning HYPERStack cell culture vessels, Courtman and colleagues successfully scaled-up the production of bone marrow-derived MSCs while maintaining cellular characteristics such as identity and potency.2
For more information, explore our Bioprocess resources or download this infographic to help you choose your ideal Corning vessel for scaling up. Whatever your work requires, Corning’s got you covered.
*Another benchtop scale-up option is Falcon Multi-Flask cell culture vessels, which come in three- and five-layer options.
References
1. McIntyre LA, Stewart DJ, Mei SH, et al. Cellular immunotherapy for septic shock. A phase I clinical trial. Am J Respir Crit Care Med. 2018;197(3):337-347.
2. Khan S, Davila L, Salkhordeh M, et al. cGMP-compatible large-scale production of mesenchymal stem cells (MSCs) in xeno- and serum-free media for allogeneic cell therapies. Ottawa Hospital Research Institute. Ottawa, ON, Canada.