Project
Vaccine Manufacturing Expansion
We provided comprehensive engineering and design services for a 65,000-square-foot expansion of vaccine manufacturing operations to meet increasing demand and stringent regulatory standards.
The upgraded facility will feature advanced biosafety level 2 (BSL-2) and occupational exposure limits (OEL) 10-100 µg/m3 containment standards, solvent-based formulation, aseptic vial filling, two lyophilizers, and cold-storage capabilities. It will also include a high-speed packaging line, automated visual inspection and comprehensive cold chain packaging, all designed for compliance with European Union Good Manufacturing Practices (GMPs).
Increasing demand meant that the existing vaccine manufacturing operations were no longer sufficient. The project was the largest capital investment to date for the owner and a strategic shift in its vaccine manufacturing capabilities, backed by funding from the Biomedical Advanced Research and Development Authority (BARDA) in response to urgent public health readiness needs.
From regulatory readiness to sustainability and operational uptime, this expansion illustrates our ability to deliver fully integrated, compliant and future-focused solutions in the animal and human health sectors.
Client
Confidential
Location
Southwest
Region
Southwest
Services
Industrial, Manufacturing & Optimization
Industry
Advanced Production
The production platform includes an advanced high-speed vial-filling line capable of handling 400 vials per minute, automated visual inspection systems and full cold-chain packaging integration to support end-to-end temperature-sensitive product handling. It also includes an isolated flexible filling line for vials, syringes and cartridges to support smaller-batch advanced therapies.
The project required thoughtful planning to accommodate complex equipment specifications, clean utility tie-ins and current GMP-aligned workflows, all while maintaining a strong focus on operational flexibility, facility safety and throughput optimization. The architectural and process design emphasized proper segregation of high-potency materials, ergonomic material and personnel flows, as well as future scalability for small-batch and commercial-scale production.
Highlights and Innovations
Compliance: EU GMP standards
Inspection: Automated visual inspection systems
Formulation suites: BSL-2 formulation, solvent formulation
Filling suites: Depyrogenation, vial filling, lyophilization and isolator technology
Cleaning systems: CIP (clean in place) and COP (clean out of place)
Storage: -20F and -40F cold storage
Containment: Biosafety levels (BSL) and containment measures