Setting the right priorities and having an overarching leadership structure was key to the successful scaleup of an advanced therapy product. That’s the message of a case study recently presented by Legend Biotech.
According to Sarah Snykers, PhD, senior director of CAR-T operations at Legend Biotech, the company was able to scale up cell therapy production from preclinical research to commercial GMP-grade manufacturing in just three years, thanks to careful pre-planning.
“I think what we did was unique. We started from scratch and really built up our facility, and we did it in a quick time frame,” she says. “It was our preparation that was critical to our success. If you want to go fast, you must prepare to go fast.”
According to Snykers, who presented the case study at the recent Bioprocessing Summit Europe, the company was able to scale up from five to 300 operators within two years by—for example—training employees in GMP-grade aseptic processes.
“It might seem like this was lost time but by doing training runs, we were able to do it right the first time,” she says.
In addition, the company staggered its hiring to account for the time needed to train employees. They also spent time assessing whether the design of their facility was suitable for the next stage in the scaleup and, if not, what needed to be changed.
Finally, she says, Legend Biotech saw the ramp-up as a collaboration that involved the whole company, including quality assurance, quality control, and warehouse teams.
“We were only in our ‘comfort zone’ for short periods before ramping up again,” she says. “And, by doing that, we were able to achieve a four-fold production increase in only one year.”
The facility is now running at significant capacity and the company has moved on to scaling up another facility. Speaking about the future, Snykers says that the cell therapy industry needs innovative technology for further scaleup.
“At some point, it’s key to compliance and quality to close and automate everything,” she says. “And there are now some technologies with robots on the market that can make that happen.”
The post Preparation is the Key to Successful Scaleup appeared first on GEN - Genetic Engineering and Biotechnology News.
According to Sarah Snykers, PhD, senior director of CAR-T operations at Legend Biotech, the company was able to scale up cell therapy production from preclinical research to commercial GMP-grade manufacturing in just three years, thanks to careful pre-planning.
“I think what we did was unique. We started from scratch and really built up our facility, and we did it in a quick time frame,” she says. “It was our preparation that was critical to our success. If you want to go fast, you must prepare to go fast.”
Case study
According to Snykers, who presented the case study at the recent Bioprocessing Summit Europe, the company was able to scale up from five to 300 operators within two years by—for example—training employees in GMP-grade aseptic processes.
“It might seem like this was lost time but by doing training runs, we were able to do it right the first time,” she says.
In addition, the company staggered its hiring to account for the time needed to train employees. They also spent time assessing whether the design of their facility was suitable for the next stage in the scaleup and, if not, what needed to be changed.
Finally, she says, Legend Biotech saw the ramp-up as a collaboration that involved the whole company, including quality assurance, quality control, and warehouse teams.
“We were only in our ‘comfort zone’ for short periods before ramping up again,” she says. “And, by doing that, we were able to achieve a four-fold production increase in only one year.”
The facility is now running at significant capacity and the company has moved on to scaling up another facility. Speaking about the future, Snykers says that the cell therapy industry needs innovative technology for further scaleup.
“At some point, it’s key to compliance and quality to close and automate everything,” she says. “And there are now some technologies with robots on the market that can make that happen.”
The post Preparation is the Key to Successful Scaleup appeared first on GEN - Genetic Engineering and Biotechnology News.