The patent badge is an abbreviated version of the USPTO patent document. The patent badge does contain a link to the full patent document.
The patent badge is an abbreviated version of the USPTO patent document. The patent badge covers the following: Patent number, Date patent was issued, Date patent was filed, Title of the patent, Applicant, Inventor, Assignee, Attorney firm, Primary examiner, Assistant examiner, CPCs, and Abstract. The patent badge does contain a link to the full patent document (in Adobe Acrobat format, aka pdf). To download or print any patent click here.
Patent No.:
Date of Patent:
May. 15, 2018
Filed:
Jan. 11, 2012
Colin Tuohey, Medway, MA (US);
Ted Deloggio, Allentown, PA (US);
Thomas Erdenberger, Arlington, MA (US);
Kenneth P. Clapp, Marlborough, MA (US);
Richard Damren, Marlborough, MA (US);
Parrish M. Galliher, Littleton, MA (US);
Patrick Guertin, Mendon, MA (US);
Jiyoung Lee, New York, NY (US);
Michael Fisher, Ashland, MA (US);
Colin Tuohey, Medway, MA (US);
Ted Deloggio, Allentown, PA (US);
Thomas Erdenberger, Arlington, MA (US);
Kenneth P. Clapp, Marlborough, MA (US);
Richard Damren, Marlborough, MA (US);
Parrish M. Galliher, Littleton, MA (US);
Patrick Guertin, Mendon, MA (US);
Jiyoung Lee, New York, NY (US);
Michael Fisher, Ashland, MA (US);
GE HEALTHCARE BIO-SCIENCES CORP., Piscataway, NJ (US);
Abstract
Disclosed is a single-use bioreactor bag design providing substantially equivalent maximum shear rate at the impeller tip and average or bulk shear rate over a range of power per unit working volume and rpm needed for bioculture processing. The uniformity in shear profile of the bag design providing a unique advantage when used as a scale-down or scale-up platform. Also disclosed is a linearly scalable, single-use, bioreactor system for use in carrying out a scalable biomanufacturing process, the system comprising two single-use bioreactor bags of different volumes, wherein the ratio H/D of the height of the working volume H to the diameter D of the tank, or of the bag is equal to about 1.5, and the bulk shear in each of the bags is substantially constant. The disclosed small scale system models larger scale systems from both a shear/scalability/performance basis and also from a validation and regulatory basis. In summary, the 10L bioreactor system disclosed provides for 'linear scalability' by using the same or substantially simulating the same vessel geometry, gas sparging system, impeller shape and type, polymer composition of the flexible bag/components, process control system, and shear rates as larger 50-5000 L systems.