Damien Voisard is at the heart of Merck Serono’s effort to improve the way it moves technology from research to manufacturing. As associate director of biotechnology process sciences for the Switzerland-based subsidiary of Germany’s Merck KGaA (not affiliated with US-based Merck & Company), Voisard knows that improving a technology’s progress from one function to the next is central to achieving speed, profitability and high-quality products for treating neurodegenerative diseases, cancer and infertility.
Traditionally, biotechnology researchers have developed a new cell line to use in creating, say, a protein, and then passed that technology to process development experts, who focus on a wide range of issues, including clinical trials, regulatory review and ramping up to produce commercial quantities. Development, in turn, passes the project to the manufacturing department.
Breakdowns in tech transfer between these groups can result in a wide range of issues, from process-validation failure to high rates of batch rejections, analytic methods that manufacturing cannot support and incomplete documentation – in short, a product that fails to perform as intended.
TIME AND MONEY
To improve the process at Merck Serono, Voisard helped establish a technology platform that greatly improves the way information is shared among researchers, process developers and manufacturing and establishes standards to manage the operations. The platform connects the electronic laboratory notebook (ELN) system that researchers and process developers use to document their processes and results with the manufacturing execution system (MES) used in production.
The system, purchased from an outside vendor and configured to fit Merck Serono’s needs, allows manufacturing and process developers to guide researchers from the outset on variables such as the cell-culture medium and standard processes they should employ to achieve the highest efficiency for new projects.
“That way, when they develop a cell line for a new product, the process is already compatible with the manufacturing platform,” Voisard said. He estimates the system has improved the efficiency of the overall tech-transfer process by two- to four-fold. “We can readily go from R&D to manufacturing for Phase I clinical trials,” he says. “We gain six months there. That means money.”
THE ENEMY: VARIABILITY
Savings in time and money explain why improved tech transfer has become one of the most urgent tasks in the life sciences industries, as companies seek to dramatically improve the speed at which they introduce new products. Even a three-month delay in bringing a drug to market can reduce profits by 15% or more. But speed must be accomplished without harming quality: the recall of a product can easily wipe out a company’s entire profit from an early launch.
Johnson & Johnson’s Janssen unit, which groups together all the company’s pharmaceutical products, has adopted a tech-transfer process it calls “platforming,” which improves flows of information among various functions. By creating standardized processes and vocabulary, which Janssen refers to as platforms, “we can make sure that when the R&D scientist does the first experiment, he or she understands how the same activity will be done in the plant,” said Paul McKenzie, senior vice president in charge of manufacturing and technical operations.
The great enemy of any drug company is “variability,” the prospect that a raw material used in manufacturing is somehow different than the one used in clinical trials or that a change in the process of how a drug is manufactured will undermine its efficacy.
“By platforming, we allow scientists to probe early and often into the known and potential unknown things that could be variable and thus drive manufacturing variability,” McKenzie said. He estimates that Janssen has enjoyed reductions of 10% to 40% in the time required to transfer products from one stage to another and stabilize them.
DELIVERING VALUE TO THE SCIENTIST
According to Alan S. Louie, research director at IDC Health Insights in Framingham, Massachusetts (USA), any tech-transfer system must be designed in a way that scientists find useful. “The true value is in designing a system that the researchers like and perceive that it helps them to do their jobs,” Louie said. “Anything that does the reverse of that will not get market adoption. Any innovation will have to deliver value to the company overall, but also to the person who uses it all day.”
Ultimately, improving tech transfer is aimed at unleashing scientific innovation, not choking it off. By freeing scientists from routine considerations, tech transfer leaves more time for creativity while ensuring a better outcome. ◆
