Frequently Asked Questions About Cleanroom Hosting

As biotech and pharma companies move from research into GMP manufacturing, one of the most common challenges is access to compliant cleanroom space. Traditional options often force teams to choose between building a facility or outsourcing to a CDMO. Cleanroom Hosting offers a third path.

Below are answers to the most frequently asked questions about Cleanroom Hosting, how it works, and who it is best suited for.

What is Cleanroom Hosting?

Cleanroom Hosting provides biopharma companies with access to GMP-ready cleanroom suites within an operational facility. Instead of building or fully outsourcing manufacturing, your team operates its own process inside a pre-qualified ISO 7 or ISO 8 cleanroom.

The hosting model typically includes access to compliant cleanroom space, GMP warehousing, environmental monitoring, and optional quality and operational support services. You maintain ownership of your process, data, and intellectual property while operating in a validated environment.

How is Cleanroom Hosting different from a CDMO?

With a CDMO, manufacturing is executed by a third party under their quality system, equipment, and operating model. Cleanroom Hosting keeps manufacturing in your hands.

Key differences include:

• Your team runs the process rather than outsourcing execution
• You retain full ownership of IP, data, and manufacturing decisions
• Greater day-to-day visibility and control
• Flexible engagement without long-term outsourcing commitments

Cleanroom Hosting is often preferred by teams that want control without the requirement of building infrastructure.

How quickly can we start manufacturing?

Most cleanroom suites are operational in as little as 4 to 6 weeks. The cleanrooms are already built, qualified, and validated, allowing teams to focus on process-specific qualification rather than full facility validation.

This timeline is significantly faster than building a facility and often faster than a technology transfer to a CDMO.

What cleanroom classifications are available?

Cleanroom Hosting facilities typically offer ISO 7 and ISO 8 cleanroom suites. These classifications support a wide range of clinical and early commercial manufacturing activities, including advanced therapies and small batch production.

Suites can often be combined or reconfigured as program needs evolve.

Do we keep control of our quality management system?

Yes. In a Cleanroom Hosting model, your company operates under its own quality management system (QMS) so that ownership and accountability remain with your team.

Importantly, for innovators that do not yet have a fully established QMS, Cleanroom Hosting companies such as Chrysalis can provide access to their own QMS framework. This enables teams to utilize a mature, compliant system while they build or scale their internal capabilities, ensuring continuity, compliance, and operational readiness from day one.

What support services are included?

Cleanroom Hosting commonly includes:

• Environmental monitoring performed by trained personnel
• GMP warehousing and material storage
• Gowning, waste handling, and facility services
• Shipping and receiving support
• Enterprise IT

Additional services can often be added based on your needs.

Is Cleanroom Hosting only for early stage companies?

No. Cleanroom Hosting supports a wide range of use cases, including:

• First-in-human and early phase clinical manufacturing
• Programs facing CDMO capacity constraints
• Contingency or backup GMP capacity
• Onshoring manufacturing in the United States
• Niche or small batch manufacturing
• Scale-up or scale-out strategies

Both emerging biotechs and established pharma companies use Cleanroom Hosting to maintain flexibility.

How does pricing typically work?

Cleanroom Hosting is generally structured as a predictable operating expense rather than a large capital investment. Companies pay for the space and services they use, without funding full facility construction or carrying unused capacity.

This model helps preserve capital while maintaining access to compliant infrastructure.

Can Cleanroom Hosting support business continuity?

Yes. Companies use Cleanroom Hosting as a contingency solution when their facilities experience downtime due to maintenance, expansion, or natural disasters. Having access to ready GMP space reduces risk and protects development timelines.

Is Cleanroom Hosting suitable for advanced therapies?

Cleanroom Hosting is well suited for cell therapy, gene therapy, and other advanced modalities that require flexibility, smaller batch sizes, and evolving processes. Modular cleanroom suites and integrated support services allow teams to adapt without rebuilding infrastructure.

When should a company consider Cleanroom Hosting?

Cleanroom Hosting is a strong fit if your team needs:

• Faster access to GMP cleanroom space
• Control over manufacturing and IP
• Flexibility without long-term lock-ins
• A bridge between R&D and commercial production
• An alternative to CDMO capacity constraints

For many teams, it offers the right balance of speed, control, and compliance.