Speed and Versatility
Bioprocesses have historically been tightly controlled whether they occurred in glass, stainless steel, or single-use equipment. Scaling up introduces variables, however, as bench, development, pilot, and production scales differ not only in size, but in the operation of engineering phenomena such as mass transfer and oxygenation levels, and shear stress.
Roman Rodriguez, global product manager for bioreactors at ATMI, makes a good case for retaining the same bioreactor platform or geometry throughout development to minimize the effects of these differences.
ATMI specializes in single-use bioreactors and mixing systems, which, according to Rodriguez, enable customers to retain the bioreactor’s critical physical characteristics at successively larger scales. The process-contact components of mixing systems, acquired through the NewMix® and LevTech® brands, are fully disposable and scalable. The bioreactors provide the usual benefits of reduced cleaning and cleaning validation, as well as rapid changeover.
“Pressures on cell-culture developers are increasing from regulators and due to time-to-market considerations. The disposables approach permits less down-time and saves on cleaning and validation. This is what makes disposables so attractive during development.”
He argues that, unburdened with cleaning and limitations on appropriate cell-culture capacity, process developers can test more process scenarios in parallel than ever before during development and begin a new run immediately after the old run ends, with no worries about cross-contamination. And they can achieve optimized lab-, bench-, pilot-, and production-scale cell cultures—up to 1,000 L—in a familiar, fully characterized system without re-validation.
Disposables can also come to the rescue for processes scaled down in volume to accommodate rising productivity, Rodriguez says. “Everybody wants to do more in smaller volume,” but to achieve that smoothly, processors must fully understand the mixing characteristics of the vessel.
ATMI products are designed for mammalian cell culture, but Rodriguez says they should be compatible with fermentation as well. “That’s our next step. It will require more validation, testing, and perhaps some upgrades.”