A novel continuous
monoclonal antibody (mAb) production process could help drug firms reach quality goals and cope with changing
capacity needs, according to CDMO Fujifilm Diosynth Biotechnologies.
The process in
question—full details of which will be unveiled at the annual bioProcess UK Conference later this month—is designed
to be both cost- and time- efficient, says Charles Heise, PhD, who is the CDMO’s associate director of process
development.
“The process involves a perfusion bioreactor connected to an ATF cell
retention device that continuously feeds 600L per day into downstream. Subsequent steps include low pH viral
inactivation, cation and anion chromatography, viral filtration, and formulation using recirculating TFF.
“The downstream process is based on a standard mAb purification
process; however, because we use a single column high cycling strategy, the perfusate is conditioned and
concentrated to reduce the volume of the Pro A load,” he says.
And reducing Protein A
usage represents a potentially significant saving for biopharmaceutical manufacturers as, according to one recent
study, the resin can cost between $11,000 and $18,000 per liter.
Another difference from
traditional mAb manufacturing methods is the way the technologies are combined in the new process, according to
Fujifilm Diosynth.
The firm’s CHO DG44-based
cell line—ApolloX—is used for protein expression, while its SymphonX liquid handling system is employed for the
control and management of all downstream operations, everything from chromatography and filtration through
point-of-use buffer dilution.
And linking these
processes is effective from a product quality standpoint, according to Leon Plybus, PhD, a Fujifilm Diosynth
Biotechnologies associate director, MCC process development.
“The connected process produced a similar yield to a batch process of
the same size with similar or better product quality attributes,” he points out.
The process’ continuous
operation also minimizes handling, according to Plybus, who says “Intensification allowed more efficient resin
utilization, realized through smaller columns and the automation reduced operator interventions and sampling
requirements.”
Fujifilm Diosynth
Biotechnologies operates 24-7 manufacturing processes at plants in Asia, the U.S., and Europe, including in
Billingham in Teesside in the U.K., which it describes as a “proof-of-concept facility for continuous
biomanufacturing.”
And knowledge gained from
the new process will help shape manufacturing operations at the Billingham site and other facilities, predicts
Plybus.
“The main [main takeaway from the process] has been to gain a better understanding of the process and environmental control strategy approaches and how we can transfer processes from fed-batch to perfusion processes through the use of the ApolloX cell line and SymphonX purification systems.
(Source: GenEngNews)