The pharma industry is facing a critical shortage of CMO/CDMO facilities. Customers may find themselves waiting months or even years for a new facility—therefore it’s crucial to develop ways to safely, quickly, and effectively get these labs off the ground. Lab Manager speaks to Joe Sollecito, senior director of Cleanrooms on Demand in Waltham, MA, about flexible hybrid cleanroom options—multi-product, multi-tenant facilities that also provide support services like materials management, asset management, training, IT support, and more.
Q: What are some of the challenges of developing a space with no particular occupant in mind?
A: While each cleanroom facility is customized to meet customers’ needs, we begin with a standard design and personnel-material flow process for each cleanroom. It's standard cleanroom practice to have unidirectional personnel and material flow. So in all cases, our basic layout begins with clients entering a gowning vestibule, from which they enter into the core room (or rooms), where they would then perform their manufacturing operations. From that core room, personnel exit into a gown-out vestibule to remove all of their cleanroom garments.
The majority of our clients perform work that is suitable for work in ISO 7 classified cleanrooms. They typically do aseptic manipulations in ISO 5 biosafety cabinets. Those pieces of equipment are commonly used in biopharmaceutical manufacturing, and are part of our standard offering for prospective clients.
That being said, customization is essential to the way we work with clients. We take each prospective client through an initial discovery process, with both an interview and a questionnaire. This process helps us understand what each client needs from a room, as well as their service requirements. That understanding allows us to perform a proper facility fit. In some cases, the process opens up a discussion that identifies appropriate modifications to the facility to best suit the client's needs.
Q: What are the advantages of flexible hybrid cleanrooms?
A: In a nutshell: Speed to clinic. We offer a practical alternative to either building out a facility themselves or to outsourcing the work to CMOs/CDMOs. Traditionally, the time required to build out and qualify a cleanroom for use can range from 24 to 48 months, depending on requirements. After buildout and CQV, a company would also have to staff and maintain the facility—even if the company is not yet in a position to fully utilize the space they've created. It's time consuming and expensive, especially for fast-growing or early-stage companies.
Another alternative is to work with a contract manufacturing organization. The CMO or CDMO model poses different challenges. Companies typically have to reserve slots in CMO or CDMO manufacturing schedules with long lead times. While a company may be able to reach a pre-agreement on the type of work the CMO or CDMO would be performing when their time slot becomes available, the process lacks flexibility. Often a client may still be discovering and perfecting their science as well as their manufacturing process when a time slot commitment is reached.
The hybrid model gives companies the space and time to work on continuous improvement where necessary. It also allows them to reach decision points more quickly than they might through either of the other two alternatives.
Q: How can clients adjust their cleanroom facilities once they've moved into a lab space?
A: An advantage to our cleanroom design approach is that it is based on flexible wall panel design that can be reconfigured to reorganize the cleanroom space according to a client's needs, if those needs change during their tenure on-site.
In the facilities we're building, cleanrooms are essentially organized side by side. If a client needs more than a single room, they have the option to license adjoining rooms, and if necessary interconnect those rooms to create more manufacturing space. There are also cases where clients may have multiple processing streams to their manufacturing process and need to handle those processes in separate but co-located spaces. So having these rooms organized in sets gives clients added flexibility.
We have worked with several clients whose needs have evolved over time—either in the way in which they would use their space, or in adding additional space to their footprint. In a traditional cleanroom sheetrock wall construction, reorganization of space would be more difficult, more invasive and considerably more messy than our flexible panel approach.
Q: Are there long-term cost savings or time savings that are associated with flexible hybrid cleanrooms?
A: The biggest advantage is that when using a flexible hybrid cleanroom, clients are paying only for what they need, without being burdened by the long-term financial commitment that comes with building and operating a facility.
In most cases, once a facility is built, it's not easily transferable to a new client. So if a company no longer needs all of its facility space, it can be difficult to convert it for use by another company. It's essentially an illiquid asset.
Beyond the cost savings that comes with using a hybrid cleanroom, however, there is the added benefit of wraparound services provided with this cleanroom on demand model. By offering services like expertise in Good Manufacturing Practices, material handling and storage, and more, we support compliance so that companies can focus on their science.
Q: What is the quality assurance or inspection process like with flexible hybrid cleanrooms?
A: We are routinely audited in two ways. First, we are often audited by the quality arm of client companies, to evaluate and qualify us as a supplier of services to their organization. Similarly, when clients wish to advance their clinical programs in Europe, they need to enlist a Qualified Professional (QP) to support their application process. We've been assessed through QP audits on multiple occasions.
Through those inspections and audits, we've been qualified as a supplier of services to client companies. Auditors assess our cleanroom design, the way that we have qualified and validated it, and the measures we take to maintain it in the validated state. That includes the design and all of the validation qualification testing associated with ensuring that the room is ready for use.
Our wraparound services are also qualified. The services most frequently and extensively used are manufacturing commissioning qualification validation (CQV), material management and release, and supply chain activities in support of the client manufacturing operations.
Ultimately, quality management is a shared relationship. We focus on clients’ raw material process; the release of intermediates and finished drug products or drug substances are the responsibilities of the client quality group. We maintain the infrastructure of the facility and ensure that the wraparound services clients require are being maintained and qualified with GMP compliance.