At the Cell Therapy Manufacturing & Gene Therapy Congress in Brussels, Belgium, yesterday, Ohad Karnieli – co-founder and CTO of process development firm Karnieli Ltd - spoke about manufacturing strategies and expressed his belief that the cell therapy sector could not be sustainable without implementing automated production.
“There is no way this will become a practical industry unless we change the paradigm of thinking and move towards the way cars are manufactured, by trying to build in as many automated steps as possible,” he told delegates.
The more people involved in the manufacturing, the greater the cost, and the greater the chance of contamination, he said, citing an example of how making even a small number of (CAR) Chimeric Antigen Receptor T-Cells is labour intensive.
Making just 1,000 doses a month would require hundreds of bioreactor runs making batches over a 10 day cycle, he said. Incorporate the number of operators and supervisors required, the turnaround time and QA/QC and the total manufacturing workforce could be as many as 500.
“We need to minimise the people and automate the process,” Karnieli, the former Vice President of Technology & Manufacturing at Pluristem, told the room.
Supplier-led shift
Dieter Hauwaerts, VP of Operations at Belgium-based biopharma Celyad agreed, but said automation can only be implemented through with supplier-led technology innovations and closer workings with industry.
“We’re moving in the right direction but we are not there yet. We have some plug-and-play equipment but we need much closer relations between cell therapy makers and suppliers,” he said, adding the first stage of the paradigm shift would be to reach some widely accepted common standards, and “then we will see the real acceleration in automated bioreactors and equipment.”
Karnieli continued to tell the congress that “four years ago, most [bioprocessing tools] companies didn’t show any attention to this industry, but Biophama’s advances in CAR-T cell therapies has shifted interest into cell and gene therapies.
“Companies like GE, Sartorius, and Thermo Fisher have now strategically started targeting the sector.”
Only those which co-operate will survive…
But Hauwaerts stressed the need for closer collaboration between vendors to develop common standards. He predicted that, if this collaboration takes place, within five years the burden for a cell therapy maker of selecting an intrinsic automated manufacturing system would be gone.
“I, as a product developer, should not have to worry about this anymore,” he said, and added the sector needs to “avoid being forced to stick with one company and be able to switch between suppliers.”
A representative from one supplier, Pall Corporation, commented on this, agreeing automated cell therapy tech is being developed by all vendors, but each supplier has different components. “We need to work as an integrated industry to create solutions.”
And – in what sounded like an ominous warning for the M&A-heavy bioprocessing sector - Hauwaerts said “the suppliers that are willing to co-operate will survive.”