US 12,435,305 B2
Integrated continuous isolation of fluid streams from sterile process vessels
Robert Snow, Southborough, MA (US)
Assigned to Genzyme Corporation, Cambridge, MA (US)
Filed by Genzyme Corporation, Cambridge, MA (US)
Filed on Sep. 21, 2020, as Appl. No. 17/027,017.
Application 17/027,017 is a continuation of application No. 14/918,107, filed on Oct. 20, 2015, abandoned.
Claims priority of provisional application 62/068,181, filed on Oct. 24, 2014.
Prior Publication US 2021/0002601 A1, Jan. 7, 2021
Int. Cl. C12M 3/00 (2006.01); C12M 1/00 (2006.01); C12M 1/12 (2006.01); C12M 1/26 (2006.01); C12P 21/00 (2006.01)
CPC C12M 37/00 (2013.01) [C12M 23/58 (2013.01); C12M 29/04 (2013.01); C12M 29/10 (2013.01); C12M 29/26 (2013.01); C12M 33/04 (2013.01); C12M 37/02 (2013.01); C12M 37/06 (2013.01); C12P 21/00 (2013.01)] 18 Claims
OG exemplary drawing
 
1. A system for isolating sterile process streams from non-sterile environments, comprising:
a component of a biological manufacturing system comprising a fluid outlet and a liquid comprising a recombinant therapeutic protein, wherein the component of the biological manufacturing system is a bioreactor, a chromatography system, a microfiltration (MF) system, or an ultrafiltration/diafiltration (UF/DF) system; and
at least one isolation vessel comprising:
(i) a sterilizing gas-filled headspace within the isolation vessel, wherein the sterilizing gas is selected from the group consisting of: ozone, ethylene oxide, nitrogen dioxide, or vaporized hydrogen peroxide;
(ii) a fluid inlet in fluid communication with the fluid outlet of the component of the biological manufacturing system and configured such that fluid entering the top of the isolation vessel passes through the sterilizing gas-filled headspace within the isolation vessel;
(iii) a fluid outlet configured such that fluid exiting the isolation vessel is removed from below the sterilizing gas-filled headspace within the isolation vessel;
(iv) at least one gas inlet; and
(v) at least one gas outlet configured to continuously or periodically vent gas from the isolation vessel; and wherein the fluid outlet of the isolation vessel is in fluid communication with a receptacle for accepting and disposing of waste material.