High pressure pump speeds up virus filtration

Good­win Biotech­nol­o­gy Inc. (GBI) is a US-based, GMP con­tract devel­op­ment and man­u­fac­tur­ing orga­ni­za­tion (CDMO) that offers cell line devel­op­ment, process devel­op­ment, cGMP con­tract man­u­fac­tur­ing, and asep­tic fill/finish of mam­malian cell-cul­ture derived mon­o­clon­al anti­bod­ies, recom­bi­nant pro­teins, vac­cines, and anti­body drug con­ju­gates (ADCs) for ear­ly and late stage clin­i­cal trials.
Seek­ing to speed up com­ple­tion of a purifi­ca­tion plat­form for one of their cus­tomers, they found that their exist­ing pump tech­nol­o­gy could not han­dle the high pres­sures on the ultra­fil­tra­tion mem­branes for the large vol­umes required. After opt­ing for Watson-Marlow’s new Quan­tum peri­staltic pump tech­nol­o­gy, they were able to con­cen­trate 1500 liters of a prod­uct to 100 liters in about 7 hours.

Higher pressure needed

GBI was work­ing on a plat­form for a two-step con­cen­tra­tion process involv­ing Viral Fil­tra­tion (VF) and Ultrafiltration/Diafiltration (UF/DF). As a CDMO, GBI has com­plet­ed more than 400 projects, most­ly for Phase I through Phase III clin­i­cal tri­als. They have devel­oped and opti­mized biore­ac­tor and purifi­ca­tion process­es for such indus­tri­al­ly rel­e­vant cell lines as CHO, NS/0, BHK, 293, as well as murine hybrido­mas. Glob­al Health & Phar­ma News recent­ly named GBI Bio­log­ics cGMP Man­u­fac­tur­er of the Year 2018.
GBI typ­i­cal­ly puri­fy har­vest­ed anti­body from the 500 liter fed-batch biore­ac­tor process plat­form, with con­cen­tra­tion nor­mal­ly at lev­els of 5 mil­ligrams per mil­li­liter (mg/mL) or less. For new per­fu­sion biore­ac­tor process plat­form, anti­body is puri­fied from more than 10,000 L har­vest, where the inter­me­di­ary process pres­sures were also expect­ed to be high. Their exist­ing pumps for fed-batch process did not have suf­fi­cient pres­sure to dri­ve the large scale UF/DF sys­tem or VF fil­ters for per­fu­sion process whilst at the same time con­trol­ling flow was also an issue.

Quantum pump the best fit

GBI learned about this new high pres­sure sin­gle-use (SU) peri­staltic pump tech­nol­o­gy which is ide­al­ly suit­ed for down­stream fil­tra­tion appli­ca­tions deliv­er­ing vir­tu­al­ly pulse-free lin­ear flow. The new Quan­tum pump, devel­oped by Wat­son-Mar­low Flu­id Tech­nol­o­gy Group, deliv­ers high­er accu­ra­cy with flow lin­ear­i­ty inde­pen­dent of back-pres­sure, which was ide­al for this requirement.
The Quan­tum pump has a very high turn down ratio (4000:1) and a pow­er­ful motor which responds rapid­ly to changes in down­stream pres­sure pro­vid­ing lin­ear speed con­trol across a wide range of pres­sures, (0 to 43.5 psi (3 bar)). At the same time the unique sin­gle-use car­tridge with four par­al­lel flu­id paths acts to deliv­er extreme­ly low pul­sa­tion (only 1.74 psi (0.12 bar)), at full speed which is a key require­ment for reli­able oper­a­tion of many fil­tra­tion schemes.

Viral filtration and concentration steps

Accord­ing to GBI, the new Quan­tum pump tech­nol­o­gy offers flow accu­ra­cy, sus­tained high pres­sure, improved pro­cess­ing time, and a small foot­print for the pow­er it can sup­ply. Also, an intu­itive user inter­face makes it extreme­ly easy for work­ers to use. New employ­ees have been able to begin using the pump prop­er­ly with­in two min­utes of start­ing it up. Start­ing and stop­ping and grad­u­al­ly step­ping up the pump speed are accom­plished with a push of a but­ton. The dis­play makes it easy to increase in grad­ual incre­ments and get feed­back on status.