AbbVie has opened a mammalian cell culture-based drug manufacturing facility equipped with both stainless and single-use equipment, as part of a $320m investment in Singapore.
Changes to biologics manufacturing will have to go beyond swapping steel vats for single-use to adapt to future industry needs, says Amgen’s drug development expert.
Phage manufacturers are yet to take advantage of single-use techs says Cellexus, which hopes bioreactors employing its ‘air lift’ system will win it customers in this emerging niche.
The environmental impact of single-use biosystems remains lower than stainless steel despite difficulties in the disposal of bioreactor bags, says Sartorius.
Catalent has replaced all stainless steel bioreactors at its biologics facility in Middleton, Wisconsin with single-use techs citing cost and flexibility advantages.
Retrofitting stainless steel plants with single-use systems is driving a “paradigm shift” in drug production but creates logistical problems, an AAPS panel said.