DPS’s Starkman explores the next generation of biopharma manufacturing at PDA annual meeting in Anaheim
Barry Starkman, Principal Consultant, Parenteral Manufacturing with DPS was one of the main speakers at the Parenteral Drug Association’s (PDA) annual meeting in early April in Anaheim, California.
Speaking on the topic “Reaching for the next generation of biopharma manufacturing”, Starkman said that one of the biggest issues is investment. “The cost for putting in a filling line, once you’ve made the decision to do that, is pretty steep.” For this reason, he explained, some biologics manufacturers are using their clinical manufacturing facilities to launch. This enables the company to gauge how well the product performs on the market before committing to invest in flexible manufacturing technology.
Starkman, who handles the conceptual design of facilities for DPS Engineering’s clients, also pointed out that companies that have invested significantly in the research and development of a new biologic product may be cautious about taking the risk when there are major obstacles to overcome in getting the product on the market in a timely manner, particularly when one of those hurdles is fitting next generation manufacturing technologies in with existing regulations.
He added that regulatory agencies, such as the US FDA, understand the need for innovative manufacturing technology. “I think there’s been a step change,” Starkman said. “There is more of an openness. From what I’ve seen with DPS clients, the key to receiving regulatory approval when implementing new technologies lies in truly understanding the manufacturing processes of the new equipment and effectively communicating this to regulators.
Risk assessments, in particular, have proven to be an effective tool. “Certainly, FDA has moved toward new technologies as an organization because they see the value in it. It’s still in its early stages but I think it’s in the right direction, for sure,” he said.
Starkman explained that training becomes particularly pertinent when working with automation, which requires a different level of understanding. A worker on the production line must understand “how it feels to control the equipment, the days of just being able to turn a wrench and being able to set up a machine like that are somewhat diminished.”
When building a line, he told the PDA meeting that DPS Engineering brings the workers who will be responsible for the line into the design process, including taking operators to specialized training at a site in Germany. This ensures the workers understand upfront how the machine works, moving up the learning curve, and fostering commitment on both sides.
“You need to have that kind of commitment in the parenteral drug business because the criticality of what we’re doing is so important,” Starkman explained. “Building that relationship among all the parties involved is very important, and it starts at the very beginning.”
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