A Portuguese research institute has made important strides in implementing continuous manufacturing for cell and gene therapies (CGTs). A team at iBET, a private not-for-profit institute that bridges industry and academia, reports that it took an early lead in process development for advanced therapies and is currently doing work for pharmaceutical companies, startups, and instrument manufacturers.
That’s according to Manuel Carrondo, PhD, VP of business development at iBET and a former professor at NOVA University of Lisbon. “To give you a perspective, we did the first perfusion for retrovirus vectors for gene therapy in the 90s,” he says.
iBET did process development for virus production at a time when it was otherwise mainly of interest to medical doctors and biologists, explains Carrondo: “We arrived early [to CGT] because we were looking for areas where not many people were active in understanding and developing processes. Everyone else was too busy with monoclonal [antibodies] and things like that.”
Later the team worked on upstream and downstream process development for induced pluripotent (iPSC) and mesenchymal stem cells (MSCs), continues Carrondo, who will be speaking about continuous processing for CGTs at BioProcess International Europe in May.
The aspects of bioprocessing they’ve worked on, he says, include continuous chromatography and diverse tangential flow filtrations, as well as process analytical technologies and design of experiment.
“What we’re trying to show is that by doing continuous integrated [processing], you have always better quality, less cost of goods and—more than everything—it’s easier to keep the processes sterile,” he tells GEN, emphasizing that this is especially important with cells as they cannot be filtered for purity at the end of the process.
The institute has worked on bioreactors of up to 50 L and are starting to work at scales up to 200 L, points out Carrondo. They work at cGMP standard and to support technology transfer to their pharmaceutical industry partners.
Carrondo stresses, however, that continuous processing for CGTs does not yet mean full control and automation.
“Everything is very manual and small scale. Having it continuous saves on cost, improves quality, and facilities sterility, but it can’t be automated in the same way as monoclonals—or like in an oil refinery.”
