Creating a next-generation cleanroom environment for viral vector and gene-therapy manufacturing.
FinVector is a leading Finnish biopharmaceutical company specialising in viral-vector–based gene-therapy products. To support the development and commercialisation of a new cancer medicine, the company required a fully modernised cleanroom facility that provides strict contamination control, stable environmental conditions and full compliance with both EU-GMP and FDA regulations.
The project transformed existing laboratory and office spaces into an 800 m², highly controlled cleanroom environment. Advanced HVAC, pressure management, monitoring solutions and hygienic modular structures form a seamlessly integrated whole that supports safe, reliable and scalable production of high-value therapies.
A cleanroom designed for the future of gene-therapy production
The development and manufacturing of viral-vector medicines require uncompromising control over air purity, particle counts and microbial contamination. The new facility provides precisely engineered conditions that support aseptic processing, high cleanroom hygiene classes and contamination-free workflows.
The cleanroom layout follows production logic—separating personnel and material flows, creating clear zoning and enabling safe transitions between different hygiene levels. Critical spaces were defined according to stringent GMP requirements, ensuring that each stage of the manufacturing process takes place under the correct environmental conditions.
Transforming an existing structure into a controlled environment
Realising a high-grade cleanroom inside an existing building required careful coordination across structural, mechanical, electrical and automation disciplines. The original premises were not designed for pharmaceutical production, so systems had to be integrated with millimetre-level precision.
Air-handling units, pressure cascades, ducting, electrical systems and cleanroom wall structures were adapted to the building’s geometry while maintaining airtightness, cleanability and energy efficiency. Despite the challenges typical to retrofit projects, the facility was delivered on schedule and validated according to both EU and US regulatory standards.
Environmental stability and operational reliability
Stable environmental conditions are central to viral-vector production. The HVAC and pressure-control systems were dimensioned according to actual need—avoiding oversizing and reducing energy use, while safeguarding the required temperature, humidity and particle-level stability.
The facility includes nearly 150 monitored points for differential pressure, temperature and humidity, providing real-time visibility and traceability for production teams. Automation and monitoring systems support consistent quality control and make routine operational work smoother and safer.
Personnel and material routes were designed to minimise cross-contamination risks, with clearly defined clean and unclean pathways and ergonomic room adjacencies that support efficient, compliant workflows.
Supporting long-term growth and regulatory compliance
The new cleanroom environment enables FinVector to manufacture gene-therapy products at a commercial scale while meeting strict regulatory requirements. The facility:
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supports the safe and efficient production of viral-vector therapies
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provides validated and fully monitored processing conditions
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meets EU-GMP and FDA compliance requirements
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improves process reliability and contamination control
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offers a scalable foundation for future expansion
The project illustrates how precise engineering, high-performance cleanroom solutions and multidisciplinary collaboration can elevate both scientific capability and biopharmaceutical production quality.
Project in numbers:
- Country: Finland
- Location: Kuopio
- Area: approx. 800 m² cleanrooms
- Purpose: viral-vector and gene-therapy manufacturing
- Classification: EU-GMP & FDA compliant
- Project type: cleanroom retrofit and technical upgrade
- Engineering scope: layout design, HVAC & pressure control, BAS, electrical systems, monitoring and validation
- Scale: part of a 25 M€ facility development programme
ASC partner working for the FinVector facility
- Granlund – HVAC, electrical, BAS, monitoring design, supervision, cleanliness management and validation.
Contact
Jukka Vasara
Chairman, ASC & Vice President, Granlund
+358 50 067 5654
jukka.vasara@granlund.fi
https://granlundgroup.com