Cleanroom Hosting vs CDMOs: Which Manufacturing Model Gives Biopharma Companies More Control?

Biotech and pharma companies face an important decision when moving from lab-based research to early phase clinical manufacturing. The traditional approach has been to partner with a contract development and manufacturing organization (CDMO), a pillar in the biopharma ecosystem that provides specialized expertise, established quality management systems (QMS), and production capacity. At the same time, the CDMO approach can become a constraint and supply risk, particularly when speed to milestones and the flexibility to adapt to inevitable change are critical to success.

Chrysalis Cleanroom Suite Hosting within fully GMP-compliant, operational facilities offers a strong alternative. Our GMP-ready cleanrooms come with integrated ancillary support services, enabling companies to run their own manufacturing operations without prohibitive up-front fees or reliance on external partners for critical, value-defining manufacturing activities. In the Chrysalis hosting model, QMS support, QA personnel, operations assistance, and environmental monitoring can all be provided flexibly, based on each company’s needs. This post compares both models across speed, cost, flexibility, and operational ownership to help teams choose the right fit.

What Is Chrysalis Cleanroom Suite Hosting?

Cleanroom Hosting gives biopharma companies access to GMP-ready cleanroom facilities within Chrysalis’ facility, staffed warehousing and material storage, on-site environmental monitoring expertise and personnel, and integrated operational and Quality Assurance (QA)/QMS support services. Your team maintains ownership of your GMP manufacturing process, equipment, data, and intellectual property (IP), in a GMP-compliant environment. With an operating model that is fully portable, any necessary tech transfer can be completed with far less time, expense, and risk. The flexibility built into our QMS may eliminate the need for tech transfer altogether. When customers assume full ownership at the appropriate time, they can transition smoothly into late-phase or commercial production.

This model truly democratizes innovation in biopharma, enabling speed, control, and predictable access to manufacturing space without time, schedule and financial constraints.

What Do CDMOs Offer?

CDMOs are now well established in traditional drug product development and, more recently, innovative players have emerged that recognize the need to evolve to serve the differing needs of biologic products and complex advanced therapies. These CDMOs often differentiate themselves by bringing scientific expertise, turnkey manufacturing operations and ownership of the regulatory manufacturing licenses. This can be advantageous for standardized, well-characterized processes for teams that prefer a fully outsourced, ‘hands-off’ approach to their product or manufacturing process..

Because CDMOs manage multiple clients and programs, considerations during the vendor selection process should include:

• Impact of shared capacity, manufacturing resources and scheduling demands
• Impact or risk of limited day-to-day visibility and ownership typical of outsourced operations
• Tech transfer requirements should multiple CDMO vendors be required, for example – players with early development expertise vs capacity players for late phase/commercial production
• Does the capacity and expertise suit small scale niche manufacturing processes, and can it adapt as needs change?

Chrysalis Cleanroom Hosting vs CDMOs: Key Differences

1. Speed to Start

CDMO: Timelines often depend on tech transfer requirements and shared scheduling – can be quick to start development, usually several months to GMP

Cleanroom Hosting: Teams can begin operating in GMP-ready suites in as little as 4 to 6 weeks.

2. Control of Process and IP

CDMO: The CDMO executes operations under its own quality system.

Cleanroom Hosting: Your team operates under your quality system with full support for implementation and management should it be required. Flexibility on QMS accountabilities as processes and products progress through the development life cycle.

3. Flexibility

CDMO: Structured engagement models and scheduling commitments with a domino effect of delay can limit adaptability.

Cleanroom Hosting: Flexible terms allow teams to scale space and services both up and down as needs evolve.

4. Cost Structure

CDMO: significant up front payments, batch pricing that reflects full facility overhead and change orders reflect the full-service outsourcing model.

Cleanroom Hosting: Companies pay for the specific space and services they choose, offering predictable budgeting.

5. Transparency and Oversight

CDMO: Visibility varies across providers based on their systems, project management capability and operating models.

Cleanroom Hosting: Full operational transparency, partnership and collaboration because your team is embedded onsite running the process. Best in class project management overseeing the team.

Who Should Consider Chrysalis Cleanroom Hosting?

Cleanroom Hosting is a strong fit for:

• Emerging biopharma innovators preparing for first-in-human trials
• Teams needing rapid access to GMP space
• Programs experiencing timeline pressures
• Organizations with evolving or complex processes
• Groups seeking temporary or contingency GMP capacity
• Companies onshoring manufacturing in the United States
• Companies looking for consistency and stability with supply chain security from early through late phase/commercial manufacturing
• Service providers or technology developers seeking close proximity to customers

The Chrysalis Advantage

Chrysalis provides GMP cleanroom hosting across three facilities in Massachusetts and North Carolina. Each location offers:

• GMP-ready cleanroom suites and GMP ‘facility within the facility’ options
• GMP manufacturing in 4 to 6 weeks
• Integrated environmental monitoring and warehousing expertise and staffing
• On-site Quality and GxP support services – flexibly to meet you where you are
• Flexible terms tailored to program needs
• Full control of process, data, and IP
• Our goal is simple: remove infrastructure and ongoing operational cost barriers so innovators can focus on the science, process and milestones that matter.

CDMO partnerships will always play a strong and critical  role in supply of medicines to patients. The Chrysalis model ensures that no innovation is excluded where the needs and outsourcing option may not fit.

To explore whether Cleanroom Hosting is the right model for your program, connect with the Chrysalis team for a consultation.