PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the May 2010 edition from ATMI and SciLog.
Bioreactor simplifies scale-up and qualification
The PadReactor from ATMI (Danbury, CT) is a scaleable, single-use bioreactor that incorporates a square bag in a square tank. The bioreactor’s PadMixer technology includes a sparger integrated into the mixing element and achieves gas transfer and mixing at low tip speed and low shear. The system’s gentle mixing technique helps to achieve high yields, high cell density, and high productivity per cell. The PadMixer unit is scaleable from 20 to 2000 L, and the PadReactor unit is available in 20–1000-L sizes. The bioreactor’s scaleability helps close the gap between development and manufacturing, according to the company.
In addition, the bioreactor is available with an open-architecture process control that allows personnel to use a turn-key integrated controller or any other preferred controller. The systems also use ATMI’s Integrity TK8 film-polymer vessels. After a manufacturer qualifies the multilayer film for use in a process, it does not need to requalify other Integrity processes or vessels of various sizes.
Purification system maintains constant flow rate
SciLog’s (Middleton, WI) mobile SciFlex 150 tangential-flow filtration system is designed for pilot-scale biopurification applications. The system’s separate, independently controlled feed and diafiltration pumps allow for automated maintenance of constant flow rate or pressure during ultra- or diafiltration. Precalibrated in-line sensors provide real-time process data about pressure, temperature, and conductivity, while a balance measures the retentate and permeate in the system.
The SciFlex device is compatible with disposable tubing sets that eliminate the need for cleaning and reduce the potential for cross-contamination. Disposable tubing sets also allow the unit to accommodate flat-sheet and hollow-fiber filters from any manufacturer.
A touch-screen interface allows operators to control the system, including the diafiltration and feed pumps. The touch screen also provides real-time trending, documentation, and connectivity for data-collection applications. The control unit achieves the target flow rate and maintains diafiltration retentate by controlling set points semiautomatically.