PROCESS TECHNOLOGY FOR BIOLOGICAL PRODUCT MANUFACTURING AND DOWNSTREAM PURIFICATION
Provided herein are, inter alia, biological manufacturing and downstream purification processes.
1 . A dynamic filtration apparatus for removing impurities from a biological product in a heterogeneous mixture, comprising:
a filter membrane extending between a feed reel and a collection reel, the filter membrane having a target region that is configured to receive the heterogeneous mixture from at least one output head configured to dispense the heterogeneous mixture onto the target region;
a membrane support structure to structurally support a portion of the filter membrane that is positioned between the feed reel and the collection reel to create the target region;
at least one support member to stabilize the transport of the filter membrane across the membrane support structure;
a vacuum system configured to apply negative gauge pressure across the dynamic filter membrane.
2 . The apparatus of claim 1 , further comprising a wash buffer line.
3 . The apparatus of claim 1 , wherein the filter membrane comprises polyethersulfone (PES), hydrophilic polysulfone, cellulose ester, cellulose acetate, polyvinylidene fluoride (PVDF), hydrophilic PVDF, polycarbonate, nylon, polytetrafluoroethylene (PTFE), hydrophilic PTFE, or any combination thereof.
4 . The apparatus of claim 1 , wherein the filter membrane comprises a pore size in the range from about 0.1 μm to about 1 μm.
5 . The apparatus of claim 1 , wherein the membrane support structure includes a series of parallel slots.
6 . The apparatus of claim 1 , wherein the gauge pressure ranges from about −0.05 bar to about −0.98 bar.
7 . The apparatus of claim 1 , wherein the membrane support structure has a substantially smooth contact surface.
8 . The apparatus of claim 1 , wherein the support member has a substantially smooth contact surface.
9 . The apparatus of claim 7 , wherein the substantially smooth contact surface has a static coefficient of friction from about 0.01 to about 0.1.
10 . The apparatus of claim 8 , wherein the substantially smooth contact surface has a static coefficient of friction from about 0.01 to about 0.1.
11 . The apparatus of claim 1 , wherein the vacuum system comprises at least one vacuum line in communication with the membrane support structure.
12 . The apparatus of claim 1 , wherein the apparatus further comprises a system configured to control the transport velocity of the filter membrane.
13 . The apparatus of claim 12 , wherein the system comprises at least one motor.
14 . The apparatus of claim 13 , wherein the motor is controlled by a closed-loop controller that operates a feedback mechanism.
15 . Use of the apparatus of claim 1 , to purify a biological product from a heterogeneous mixture.