Client
CRO and pharmaceutical QC testing provider
Service
Scope
Facility consolidation, design brief and build oversight
Standards
BSL-2, GMP, GLP, ISO 17025, controlled substances
Results Snapshot
A life sciences service provider engaged Terraforme Biosciences to consolidate two capacity-constrained facilities, a pharmaceutical quality control laboratory and a contract research organization (CRO), into a unified, purpose-built operation.
- Strategic facility integration: merged two distinct business operations into one laboratory environment optimized for both QC testing and biofilm research.
- Comprehensive design brief: detailed technical specifications covering HVAC, utilities, biosafety, hazardous materials and regulatory requirements.
- Vendor selection: RFP documentation that enabled accurate architectural partner evaluation and significantly reduced discovery costs.
- Regulatory compliance: adherence to Biosafety Level II, GMP, GLP, ISO 17025 and controlled substances regulations throughout design and build.
- Operational synergies: centralized shared processes, including media production, reagent preparation and compressed gas distribution.
- End-to-end support: ongoing oversight through facility selection, architectural design, permitting and construction.
Client Context
The client was a CRO that had recently acquired a pharmaceutical quality control testing facility as part of its growth strategy. Both the existing CRO site (contract biofilm research for medical device companies) and the newly acquired QC facility had reached capacity at their respective locations.
The organization needed to consolidate into a single facility that could accommodate both business lines, create efficiencies and position the company for growth, but it lacked the in-house expertise to translate complex laboratory requirements into architectural specifications.
The CEO needed a partner who could bridge scientific operations and facility construction: someone who understood not just what equipment was needed, but how processes flowed, which regulatory standards applied, and how exhaust capacity and electrical loads would affect daily operations.
The Challenge
For technical scientific build projects, clarity in requirements is paramount.
Science-to-Architecture Gap
Architects are not scientists. Without clearly defined requirements, an underpowered exhaust duct, a missing floor drain or an incorrect electrical load can stop equipment installation and force expensive remediation.
Complexity Management
A build of this scale demands rigorous attention to many complex equipment pieces, processes and regulatory requirements. Missing a single specification can cascade into delays and cost overruns.
Multi-Regulatory Environment
The facility had to comply simultaneously with Biosafety Level II containment, GMP, GLP, ISO 17025 and controlled substances regulations, each with distinct facility implications.
Operational Integration
Merging pharmaceutical QC testing and biofilm CRO services meant finding synergies while maintaining the specialized environments each required.
Future-Proofing
The design had to support current operations and planned expansion into animal cell culture, PCR capabilities and scaled manufacturing.
What We Did
Building on our laboratory facility design experience, we guided the client through a phased approach to consolidation.
1
Requirements Discovery and Analysis
- Site assessments of both facilities: equipment, workflows, utilities and spatial constraints
- Equipment and utility audit: electrical, water, drainage, gases, exhaust and network needs for every instrument
- Process mapping from sample receipt through testing, data generation and waste disposal
- Hazard assessment of chemicals, biological agents, compressed gases and waste streams
2
Design Brief Development
We translated the findings into a comprehensive design brief, giving architects the precise specifications they needed without having to be laboratory experts (see below).
3
Facility Selection and Procurement
- Facility selection against the brief’s technical requirements
- RFP development so vendors understood the scope, priced accurately and spent less time on discovery
- Vendor evaluation for technical competence, experience and fit
4
Design, Permitting and Construction Oversight
- Design review in every design meeting
- Change management as equipment and processes evolved
- Quality assurance on exhaust ducts, floor drains, electrical loads and gas lines before construction
- Compliance verification for biosafety, GMP/GLP and controlled substances
The Design Brief Covered
- HVAC systems
- Electrical infrastructure
- Plumbing systems
- Compressed gas distribution
- Containment environments
- Hazardous material handling and storage
- Laboratory finishes
- Space allocation and zoning
The Approach
We combined deep laboratory operations expertise with practical facility design knowledge to bridge scientific requirements and architectural execution.
Requirements Translation
Every technical requirement documented in a format architects could use directly, preventing costly assumptions.
Risk-Mitigated Planning
Design conflicts and technical constraints identified early, before they became post-construction remediation.
Operational Synergies
Shared processes such as media preparation, reagent production, gas distribution and waste handling centralized to justify the consolidation.
Regulatory-First Design
Biosafety, quality system and controlled substances requirements built in as architectural features, not afterthoughts.
Future Capacity Planning
Infrastructure for planned expansions built in from day one, avoiding another costly relocation.
Deliverables
1
Facility Design Brief
The technical foundation for architectural planning and vendor procurement.
2
Master Equipment List
Current and projected equipment with dimensions, clearances and utility needs.
3
Process Flow Documentation
QC and CRO workflows mapped for consolidation and optimization.
4
Hazardous Materials Plan
Chemical, biological and gas hazards with handling, storage and disposal specifications.
5
RFP Documentation
Procurement materials enabling accurate, competitive vendor bids.
6
Design and Construction Support
Design reviews, construction meetings and QA checks throughout the build.
7
Regulatory Compliance Framework
Evidence of design adherence to BSL-2, GMP, GLP, ISO 17025 and controlled substances rules.
Lessons Learned
Requirements definition is everything. A missing floor drain or undersized circuit is cheap to specify correctly but extraordinarily expensive to fix after the build.
Technical details drive success. Exhaust capacity for fume hoods, electrical phase for autoclaves, drain locations for emergency showers: one missed specification can cascade into delays.
Consolidation creates strategic value. Centralizing shared processes improves both cost structure and reliability, not just rent.
Build compliance in. Biosafety, quality and controlled substances requirements are far easier to design in than to retrofit.
Future-proofing pays. Extra electrical capacity, pre-plumbed gas lines and expansion space cost far less than relocating again in five years.
Planning a Laboratory or Facility Build?
Whether you’re consolidating, expanding or building from the ground up, we translate your requirements into specifications architects can execute, preventing costly mistakes. Book a free consultation to discuss your project.
