A fit for your quality and compliance strategy

One manufacturer might be comfortable with a progressive open ballroom design that leverages closed technology to keep all operations in one suite. Another might require a more conservative approach, preferring instead to locate certain steps—their aseptic fill/finish process, for example—in a segregated space. Others will be somewhere on the spectrum between these two. With four SlateXpace™ models to work with, every manufacturer can find the combination that suits their approach to quality and regulatory compliance.

A fit for your available space

SlateXpace™ models are designed to offer flexibility inside their walls, supporting diverse product portfolios that could include anything from traditional therapeutic proteins and vaccines to novel ATMPs.

They’re also designed for flexibility outside of the production suite. They can integrate with almost any facility, new or existing. They’re especially helpful in retrofit projects where existing support columns, roof heights, utility conduits, and other constraints present significant engineering challenges.

We’ve worked for decades on countless GMP facility projects, which has given our team a nuanced understanding of what it takes to maneuver around those challenges and convert any shell building into an efficient, operable and compliant GMP space. We drew from that experience to design our four SlateXpace™ models. Each one is both standardized (for example, we’ve designed them to fit inside most column bays) and highly versatile (mix and match to find the footprint that works best in your particular situation).

This gives companies control over how they utilize their available space. One manufacturer might choose to optimize every available square foot, with three large models handling their most demanding modalities and a smaller one dedicated to simpler processes. Another manufacturer may choose instead to reserve part of their footprint for future expansion, so they take a more modest approach with a mid-sized model capable of pivoting between modalities. Whatever constraints you face, there is a SlateXpace™ combination to help you take full advantage of your available space.

A fit for each of your locations

As companies think ahead to commercialization, the dynamics of location become extremely important. Put your manufacturing center near a major transport hub and you’ll have the cost advantage of a simpler supply chain. Put it in an area known to attract high-value talent and you’ll have an easier time recruiting the innovators and the future leaders that your company needs. Bolt a production suite to a facility already providing patient point-of-care, and you’ve got an efficient way to deliver high-quality personalized medicine right to the bedside.

We developed our SlateXpace™ models with these opportunities and considerations in mind. Each package is reproducible by design, and each one can be deployed and scaled rapidly, whenever and wherever you need it. As a result, every one of your GMP cleanrooms looks and operates the same way, whether it’s located in Massachusetts or California or overseas. This reproducibility makes it easier to train new staff, deploy and maintain equipment, prepare regulatory documentation, and protect your competitive business advantage in a market defined by speed and quality.

A fit for your future

There’s no crystal ball to tell manufacturers when it’s the right time to scale their capacity for commercialization. Move too fast, and you risk funding a facility expansion for a product that fails to earn regulatory approval, or that misses the demand target. Too slow, and you could find yourself scrambling to meet demand when your product launches, which can cause irreparable damage to your reputation.

We’ve designed SlateXpace to solve this problem. It can’t magically predict your commercial success; what it cando is make that success much more possible by giving you control over if, how and when to scale your processes. Because each suite is modular, versatile, and deployable in a fraction of the time of a traditional stick-built facility, you can start with exactly what you need to support today’s operations and then scale precisely when you need to—not too soon, and never too late.

Conclusion

A SlateXpace™ suite is designed to fill a gap in the marketplace for GMP cleanrooms that do more. More versatility, balanced by a templated design that speeds up deployment; more speed, supported by robust and compliant process design; more innovation, driven by flexible systems that can rapidly pivot from one drug modality to another.

To deliver on that vision, we soon realized we had to offer more suites. SlateXpace™ now offers four distinct building blocks, to use alone or together according to the bespoke needs of any given manufacturer.

To explore all four SlateXpace™ models and start a conversation about the future of your operations, reach out to us.