When developing a new drug product, quality, safety and timing are critical. A Contract Development and Manufacturing Organization (CDMO) can be a valuable partner to help mitigate risks, avoid missteps and control costs in the process. But the success of the partnership revolves around a key step: the technology transfer.
At its most basic definition, the tech transfer is just what it sounds like: The client shares vital information with the CDMO to build a reliable process to develop and manufacture the product at hand. Still, the importance of this act cannot be overstated, says Shelly Buhay, Director of Manufacturing Science and Technology with Emergent. “It’s the piece that demonstrates that you understand the factors going into the manufacturing process, and how that impacts the end result,” she says. “It sets the stage for all of the manufacturing that comes after, for future scale-ups and for future commercialization.”
Emergent, which has more than 20 years of experience in developing, manufacturing and commercially delivering therapeutics and vaccines, partners with biopharmaceutical companies to help develop and manufacture their clinical and commercial products. As a CDMO, Emergent can serve as a “one-stop-shop” for drug developers, whether they’re focusing on small volumes of materials for clinical trials or large-scale manufacturing for commercial products, says Dan Perrin, Director of Manufacturing. “We have the development services portion, we have drug substance, drug product, analytical expertise, you name it,” he says. “Clients may not need all of that, but we can can work with clients to determine what services they need.”
Recently, a company approached Emergent with an urgent request to manufacture a product and make it available to a clinical trial on an extremely tight timeline. Thanks to an efficient tech transfer process—and because standardized platforms were available — the Emergent team managed to produce the drug candidate and fill it into vials quickly — without sacrificing quality — and helped the client meet their goals.
Of course, whatever the goal is, collaboration is key when working with a CDMO. A smooth tech transfer demands open communication and defined processes to keep timelines on track and control costs. Buhay and Perrin shared four steps for a smooth tech transfer.
- Communicate openly. Knowledge transfer is an important part of tech transfer. Be open and honest about your inputs, your outputs and your goals. If you have areas of uncertainty, be candid about those, as well. “If we understand what's going on, and we understand the client’s needs, then the client can leverage all of our knowledge and experience,” says Buhay. “We can also highlight any potential risks that we see.”
- Collaboration between Sponsor and CDMO. Some clients know their process inside and out. Others don’t. Both scenarios are welcomed, says Perrin, as long as the client is forthcoming so that there are no surprises down the line. “We want to go into the process informed,” he says. “If the client knows their process inside and out, then they can share that information with us. On the other end of the spectrum, if they don’t know the process, we can help them identify the things we’re going to need to know.” During these early conversations, some clients may learn they could benefit from Emergent’s standardized platforms, which can save time, while others may opt for a customized program to achieve their goals.
- Understand the capabilities of your analytical assays. Your analytical data is the readout of how the manufacturing process is going, says Buhay. It’s important for clients to know what their analytical assays are capable of and how they perform to understand what the data means. “You have to be able to know what’s a meaningful difference, and whether there are differences between test sites so that when you get the data you can accurately assess if the differences are coming from the manufacturing process,” says Buhay.
- Let quality and compliance be your guide. Timelines can be demanding and costs can increase, but quality and compliance must lead all decisions without compromise, says Perrin. That’s where the right CDMO partner can be of service. With a long history of commercializing their own products, he says the team at Emergent knows the demands of regulatory compliance and ushers its client partners through the necessary steps with a focus on continuous improvement. “We need a reliable operation so that we understand the data is telling us the right things, so we can make the right decisions and take the right actions,” says Perrin. “Through any of the steps above, we’re keeping quality and compliance at the forefront of everything we do.”
A strong CDMO partner knows how to manage the unique challenges a tech transfer can present. At Emergent, teams with deep molecule-to-market expertise collaborate with clients, wherever they are in their journey, to achieve their product milestones. “Having moved a number of our own products through development to commercialization, we understand the risks and demands,” says Perrin. “We’re able to leverage that experience to help others in their endeavors.”
To learn more about working with Emergent visit emergentbio.com.