In principle, the technology transfer process should be fairly straight-forward. A drug developer partners with a manufacturer, for example, and hands over all the necessary information the company needs to bring the product to market.
In reality, however, it’s one of the hairiest aspects of outsourcing partnerships and plenty can go wrong in the process. Thus, it has become a goal in the industry to make tech transfer “seamless.” But according to Richard Shook, director of Drug Product Technical Services and Business Integration at Cambrex, you need a quality-focused and transparent outsourcing partner to ensure this promise can be achieved.
“The reality is that [seamless tech transfer] is not always delivered by some providers,” Shook says.
Shook says that Cambrex, one of the industry’s leading small molecule contract manufacturers, calls a spade a spade and instead aims to invest time and resources up front to identify areas that need to be addressed at the start of the process, rather than at a later stage.
“Anytime you’re taking a technical process and exchanging information from one place to another, there are going to be many seams,” Shook says.
It’s this holistic approach to tech transfer that Shook says sets Cambrex apart, and can help the client more successfully bring drug development to the finish line.
Balancing the pharma triangle
Shook identifies three main challenges in the tech transfer process. “There is a triangle in pharma that needs to be balanced: it’s quality, time and money,” he says.
In pharma, speed to market is everything, so when it’s time to cut a corner in the triangle during the tech transfer process, quality is often the target. This is where Cambrex takes extra steps to make sure companies exercise their due diligence and avoid costly hiccups.
And yet, making quality the focus of tech transfer can be easier said than done.
For a commercial launch, Shook says Cambrex works with companies to establish a quality risk management (QRM) system and a risk mitigation strategy. Creating a properly vetted QRM matrix can be a time-intensive process that some companies would rather skip. But Shook says it’s critical to avoiding downstream delays.
“It’s always worth investing time and resources in the early stages to ensure the transfer’s success. These activities may impact the overall cost of a project by introducing additional work. However, these are countered by the time savings achieved further on in the process,” Shook says.
Setting up a robust QRM system requires that companies take a hard look at the product’s critical quality attributes — or, all of the attributes of that product that make it fit for public consumption — along with the potential equipment risks associated with scaling up. This process also helps Cambrex understand the manufacturing needs of its customers in order to more effectively transfer the needed know-how for a commercial launch.
Closing communication gaps
When partnering with a client, Cambrex often starts by addressing one of the biggest seams in tech transfer: Distance.
“It’s not like you can walk next door if you have a technical question, so communication is key.” Shook explains.
But the bigger issue is often transparency.
“I feel like Cambrex is unique because we have an extra conversation with clients to help them understand what’s possible and what the risks are,” Shook explains. “If we see something from a quality perspective, we always let our clients know what our concerns are and put a plan in place so that those risks are never realized.”
The process may not be seamless across all providers, but ultimately, Shook says that for Cambrex, recognizing and making the client aware of any issues up front is what makes the tech transfer process as seamless as possible.
“The biggest thing that makes this process successful is open communication and transparency on both sides,” Shook says. “If everyone can be open, the seams can be overcome and smoothed out to create a successful transfer and launch.”