When Spine BioPharma was looking for support in redeveloping and manufacturing a drug product recently, they found a partner in Emergent BioSolutions. As a contract development manufacturing organization (CDMO), Emergent would be able to quickly ramp up production of the drug at hand, and it would also be able to convert it to a form that would make it stable at room temperature, through a process called lyophilization. That process—also known as freeze-drying—would, in turn, simplify logistics for shipping and storage.
“We were looking for an organization that could manage a very steep learning curve, hit the ground running and be flexible enough to make science and risk-based changes to the development program in real time,” says Marc Viscogliosi, CEO of Spine BioPharma, which makes therapies for the treatment of pain and disability from chronic low back pain caused by degenerative disc disease. “As Emergent is one of the world leaders in lyophilization, we trusted their input and expertise to guide the program from development to eventual successful current Good Manufacturing Practice (cGMP) manufacturing.”
Spine BioPharma is just one of many biopharmaceutical organizations seeking assistance in the lyophilization process, which is growing in popularity. According to a report by MarketsandMarkets, the global freeze-drying/lyophilization equipment market is expected to reach $7.3 billion by 2025—from $4.9 billion in 2020—at a CAGR of 8.2%.
Jee Look, senior director of drug product development with Emergent BioSolutions, says he’s seen an exponential increase in demand for the company’s lyophilization services in two distinct areas: the manufacturing of new biologic drugs and injectable formulation; and change of formulation presentation from frozen to lyophilized presentation, as clinical trials progress from phase 1 to phase 2/3 and commercial manufacturing.
In the case of Spine BioPharma, for example, Look says lyophilization allowed for ease in storing, distributing and handling the product. “The biological drug substance is typically not stable at 2-8°C. By converting to an appropriate lyophilized form, it will significantly enhance the drug substance stability,” says Look.
Because the conventional method of preservation involves using high temperatures to evaporate liquids, lyophilization is well-suited for any product that is sensitive to heat—from food to biopharmaceuticals, including biological drugs. Lyophilization relies on a three-step process that includes sublimation, which allows ice to change from a solid to a vapor without passing through a liquid phase and can help preserve the viability of biological drugs. The process, which typically takes one to five days for common biologic drug products, also decreases the weight and volume of biopharmaceuticals, which helps with the shipping costs.
Look believes the sudden growth in interest in lyophilization is a result of an increase in biologic drug innovation and technological advancement in the lyophilization process. He also attributes it to ease of access through outsourcing, thanks to partners such as Emergent BioSolutions, which offers drug process/formulation development and manufacturing services—including the fast and flexible transfer of technology—according to the client’s timeline. “Many biotech companies are relatively small in size and may have limited resources. They may often not have in-house formulation development capabilities or equipment and seek to outsource to a CDMO who has the capacity, expertise and capabilities to support,” says Look.
That’s because lyophilization brings with it a number of challenges: It’s expensive. It adds more time to the process. It requires additional materials, including vials to reconstitute the product. And it demands a robust operation and deep expertise. “It’s as much an art as it is a science,” says Look.
For companies such as Spine BioPharma, Viscogliosi says Emergent offers a one-stop offering for drug manufacturing needs—from development and optimization to commercialization. “Emergent has done an excellent job of guiding us through the development portions of the current project under the pressure of an extremely aggressive timeline,” he says.