Introducing new processes into a busy, established facility poses significant logistical and technical challenges, according to Gregory R. Naugle, director of process development at Amgen’s West Greenwich, RI, production facility, the largest in the Amgen manufacturing network. Key issues involve ensuring the new product’s success while not rocking the boat with respect to existing processes.
Tech transfer of multiple products at differing stages of development and scaleup add to the complexity, maintains Naugle. “A high run rate facility runs continuously, and provides very little ‘white space,’ with very little free equipment. There are limited windows of opportunity to modify equipment to accommodate the new product or process.”
The top priority should be maintaining the fidelity of the currently licensed process. “When you modify shared equipment, you want to ensure you’re not altering the process that’s already there,” Naugle adds. “In essence, you want to change something without changing it. If the modification involves hardware, for example piping or the diameter of a transfer panel, you must assure there are no unintended consequences to the existing product.”
Synchronicity is what complicates tech transfers into busy plants. Under circumstances where projects enter sequentially, one is able to conduct a full “lessons learned” and still have time to prepare for the next project.
“When they’re happening simultaneously or nearly so, you don’t have the decompression time to do a lessons learned, implement those learnings, and move forward,” says Naugle. “You need to transmit that knowledge very rapidly.”
Again, the confounding variables concern the fact that cells are living organisms that are significantly affected by environmental factors.
Moreover, with high-run facilities, the operational distinctions between scaleup and tech transfer become more semantic than substantive. Both involve freeing resources for the new process and assuring the integrity of existing processes. “It’s just the nomenclature we choose to use,” Naugle, says. “If we scale up from a pilot facility in a different building we don’t consider that a tech transfer because of the co-location. But if the process were coming in from Amgen headquarters at Thousand Oaks, it would be considered a tech transfer. So yes, scaleup presents many of the same challenges as a full tech transfer, particularly when you’re talking about maintaining the fidelity of the existing process.”