Available cleanroom space has not kept up with the pace of growth in the pharmaceutical industry, and as a result is slowing time-to-clinic and holding back innovations of new therapies and products. When it comes to cleanrooms, pharmaceutical manufacturers are faced with a dilemma: should they build their own facility, spending years and millions of dollars on validation, or should they outsource to a contract manufacturing organization, standing by on a waitlist that can be up to 18 months or longer? In an industry that needs to “fail fast” to survive, that waitlist can feel insurmountable. Then again, so can spending millions in capital.
A third option that is gaining momentum—especially in the face of the COVID-19 pandemic—is leased cleanroom space. The ability to lease fully equipped laboratory space in a timely manner enables pharmaceutical manufacturers to scale-up without the need for major capital expenses.
In this Ask the Scientist, Vanessa Wiley, associate director of operations at Azzur Cleanrooms on Demand, explains the allure of leased cleanroom space, and how it can help pharmaceutical manufacturers speed innovations.
Q: What are attributes of a pharmaceutical manufacturer that would make them the ideal client for leased cleanroom space?
A: The beautiful thing about the on-demand cleanroom model is that there is no one ideal client. Instead, these spaces are ideal for any company in need of a controlled space for smaller-scale manufacturing processes utilizing single-use technology and closed systems. The cleanroom leasing model lends itself to both start-up and early-phase clients with limited staff, cell and gene manufacturing, and more established clients who require “bridge” facilities.
Compared with CMOs or self-own facilities, leased cleanroom space clients maintain full control of their processes and schedules–no construction timelines and no waiting in line. There’s also no vying for space against preferred clients with a CMO, which can be a huge burden for early-phase companies. Leased cleanroom facility clients can be in and ready to go in as little as eight weeks because the spaces should be continuously maintained for cGMP readiness.
Q: Of course, pharmaceutical manufacturers want their product to be successful, but science has taught us that’s not always possible. In cases where it is not, why is it important for companies to “fail fast” and how do leased cleanroom spaces play a role in that?
A: The cost of producing pharmaceuticals at scale means that it is essential to be able either to improve the success rate for substances produced in trial quantities or be able to move quickly from one possible product to the next. Unlike traditional CDMO/CMO models, the clientele for leased cleanrooms has 100% control of their schedules and processes in the cleanroom facilities. Therefore, they have the flexibility to pivot from one process to another, and the ability to make changes in their processes should a variable(s) need to be manipulated. By maintaining full ownership of their processes and schedules, they’re hopefully able to get their product in the hands of patients in less time.
Q: Beyond failing fast, what other benefits can leased cleanroom space offer pharmaceutical manufacturing companies?
A: Ideally, a leased cleanroom facility must go beyond just the leased space. For example, while our clients are in full control of their processes in the cleanrooms, Azzur Group also handles full-scale solutions, including material management, asset management, training services, laboratory testing, IT services, and equipment leasing. Expert staff is also available for GMP consulting and advisory services to help our clients scale up and out. Consequently, clients are able to harness control over production, maintain flexibility, increase speed to clinic, and enhance IP protection.
Q: With the pandemic seemingly entering the endemic phase, where do you see the pharmaceutical manufacturing industry after the last unexpected 2+ years?
A: Whether or not we are at the end of the road with the COVID-19 pandemic, one thing is true: this experience has changed the timelines of pharmaceutical manufacturing forever. We will continue to see a shift to not only maintaining vaccination availability to the world, but also having to treat survivors as they combat both known and as-yet unknown long-term effects of the disease. Additionally, the technology used for COVID-19 vaccines was just step one in the utilization of the research and development of mRNA treatments for patients around the world. Facilities like ours are ideal for such novel therapies. Additionally, the pandemic has thrust our industry to the forefront of the population’s mind, and the demand for safe, effective and fast delivery of novel therapies for any condition is here to stay.
Q: What about the state of other research disciplines that heavily affect the cleanroom space? Any effects from the noticeable uptick in cell and gene therapy research?
A: Biotech, cell and gene therapy, and personalized medicine are indeed at the forefront right now. And, many of these therapies are, for lack of a better term, “on demand.” Their development and delivery to patients is incredibly time sensitive and they’re delivered in small batches.
What attracted me to Azzur and what continues to motivate me is knowing that we’ve enabled and have the potential to enable so many companies to get their products to patients quickly and safely. In many cases, patients with rare diseases or severe conditions are combating limited timelines, so, the faster a therapy is delivered, the better their chances of increased quality of life. That’s the most important part of our business.
About the Expert: Vanessa Wiley is the associate director of operations for Azzur Cleanrooms on Demand. Her experience in the biotech industry began as an upstream cell culturist in process development and GMP manufacturing. Since then, Wiley has held responsibilities in laboratory, technical services and operations management. She holds a degree from San Diego State University in psychology, neurobiology and neurosciences.