Thinking about ways in which to improve the output of the manufacture of biologics has often led the pharma industry to look to other industries. The continuous process that was developed in the car manufacturing industry, as an example, provided a model where production could be streamlined through the use of automation and the harnessing of technological developments.
For the pharma industry, elements of this process were possible – with perfusion bioreactors able to be used for continuous cell culture and production formation. However, true continuous bioprocessing has proved difficult to achieve.
State backed development
The US National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) is aiming to address this through Project Call 5.2. The latest part of this strategy sees funding of $15.8m (€15.81m) provided into 14 projects looking to improve on technology and workforce developments, with the stated goal of “addressing key opportunities for innovation.”
Of those technology projects, three of the nine are focused on developing continuous and automated solutions for bioprocessing. This followed similar efforts by the organization in 2021, when it concentrated on COVID-19-related projects but also provided funding to work on continuous bioprocessing.
The latest projects include the University of Massachusetts working alongside Whirlcell, Yokogawa Corporation of America, and Pfizer to develop and validate a mammalian cell culture system with an integrated continuous upstream processing platform. Another proposal sees Rutgers University combining with the University of Delaware, Agilent, Endress + Hauser Optical Analysis to create an online sampling processes analytical technology (PAT) to enable continuous monoclonal antibody (mAb) manufacturing processes.