Unified Laboratory Facility Design for CRO & Pharma QC Integration
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 a cohesive, synergistic laboratory environment optimized for both QC testing and biofilm research.
Comprehensive Design Brief
Developed detailed technical specifications covering HVAC, utilities, biosafety, hazardous materials, and regulatory compliance requirements.
Vendor Selection Optimization
Created RFP documentation that enabled accurate architectural partner evaluation and significantly reduced discovery costs.
Regulatory Compliance Framework
Ensured 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 to maximize efficiency.
End-To-End Support
Provided ongoing oversight through facility selection, architectural design, permitting, and construction to ensure requirements were met.
Client Context
The client was a CRO service provider who had recently acquired a pharmaceutical quality control testing facility as part of their growth strategy. Both the existing CRO site (performing contract biofilm research for medical device companies) and the newly acquired pharma QC facility had reached capacity limitations at their respective locations.
The organization needed to consolidate operations into a single facility that could accommodate both business lines while creating operational efficiencies and positioning the company for future growth. However, they lacked the in-house technical expertise to translate complex laboratory requirements into architectural specifications that would ensure a successful build.
The CEO required a partner with deep laboratory design experience who could bridge the gap between scientific operations and facility construction—someone who understood not just what equipment was needed, but how processes flowed, what regulatory standards applied, and how technical specifications like exhaust capacity and electrical loads would impact daily operations.
The challenge
For technical scientific build projects, clarity in requirements is paramount
Communication Gap Between Science and Architecture
Architects, even those experienced with pharmaceutical facilities, are not scientists. Without clearly defined requirements, critical details—an underpowered exhaust duct, a missing floor drain, or incorrect electrical load calculations—can get specified incorrectly in plans, stopping equipment installation and creating expensive post-construction remediation.
Complexity Management
Managing a build of this scale requires rigorous attention to the details of multiple complex equipment pieces, processes, and regulatory requirements. Missing even a single specification can cascade into significant delays and cost overruns.
Multi-Regulatory Environment
The facility needed to simultaneously comply with Biosafety Level II containment requirements, Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), ISO 17025 standards, and controlled substances regulations—each with distinct facility implications.
Operational Integration
Merging two distinct business operations (pharmaceutical QC testing and biofilm CRO services) required identifying synergies while maintaining the specialized environments each required.
Future-Proofing
The design needed to accommodate current operations while building in capacity for planned expansions including animal cell culture, PCR capabilities, and scaled manufacturing activities.
What We Did
Building on our extensive laboratory facility design experience, Terraforme Biosciences guided the client through a comprehensive, phased approach to facility consolidation.
Phase 1: Requirements Discovery & Analysis
Site Assessments
Conducted thorough evaluations of both existing facilities, documenting equipment, workflows, utility requirements, and spatial constraints.
Equipment & Utility Audit
Performed comprehensive reviews of every piece of equipment, documenting electrical requirements (voltage, amperage, phase), water supply needs, drainage, compressed gas requirements, exhaust specifications, and network connectivity.
Process Mapping
Analyzed all laboratory workflows from sample receiving through testing, data generation, and waste disposal to identify opportunities for optimization and consolidation.
Hazard Assessment
Conducted detailed reviews of chemical handling, biological agents, compressed gases, and waste streams to establish safety and regulatory requirements.
Phase 2: Design Brief Development
We translated the discovery findings into a comprehensive design brief that served as the technical foundation for architectural planning. This document provided architects with the precise specifications needed to generate accurate plans without requiring them to be subject matter experts in laboratory science.
The design brief included detailed specifications for
- HVAC systems
- Electrical infrastructure
- Plumbing systems
- Compressed gas distribution
- Containment environments
- Hazardous material handling and storage
- Laboratory finishes
- Space allocation and zoning
Phase 3: Facility Selection & Vendor Procurement
Strategic Facility Selection
The comprehensive design brief enabled the client to evaluate potential facilities against specific technical requirements, ensuring the selected space could accommodate their needs.
RFP Development
Utilized the design brief to create detailed RFP documentation for architectural partners. This approach allowed prospective vendors to thoroughly understand the project scope, deliver accurate cost estimates, and significantly reduced discovery time and costs.
Vendor Evaluation
Assisted in evaluating architectural partner proposals for technical competence, relevant experience, and alignment with project requirements.
Phase 4: Design, Permitting & Construction Oversight
After the architectural partner was selected, we remained actively engaged throughout the design, permitting, and construction phases.
Design Review
Participated in all design meetings to ensure architectural plans accurately reflected technical requirements and regulatory standards.
Change Management
Managed evolving requirements as new equipment was introduced or processes were refined, ensuring changes were properly incorporated into plans.
Quality Assurance
Verified that specifications for critical systems—exhaust ducts, floor drains, electrical loads, gas lines—were correctly implemented before construction.
Regulatory Compliance Verification
Ensured facility design maintained compliance with all applicable regulations including biosafety containment, GMP/GLP requirements, and controlled substances handling.
The Approach
Our methodology combined deep technical expertise in laboratory operations with practical facility design knowledge to bridge the gap between scientific requirements and architectural execution.
Comprehensive Requirements Translation
We ensured that every technical requirement was documented in a format architects could work with directly—preventing the costly mistakes that occur when assumptions are made about equipment needs or process requirements.
Risk-Mitigated Planning
By identifying potential design conflicts and technical constraints early in the planning phase, we prevented expensive post-construction remediation and equipment installation failures.
Operational Synergy Identification
Rather than simply combining two facilities, we identified opportunities to centralize shared processes—media preparation, reagent production, compressed gas distribution, waste handling—creating operational efficiencies that justified the consolidation.
Regulatory-First Design
We embedded regulatory compliance requirements into the facility design from the beginning, ensuring that biosafety containment, quality system standards, and controlled substances regulations were architectural features, not afterthoughts.
Future Capacity Planning
The facility was designed not just for current operations but with the infrastructure to support planned expansions including animal cell culture, molecular biology capabilities, and scaled manufacturing—avoiding the need for another costly relocation.
Deliverables
1) Comprehensive Facility Design Brief
A detailed technical specification document covering all aspects of laboratory infrastructure, utilities, safety systems, and regulatory requirements—serving as the foundation for architectural planning and vendor procurement.
2) Master Equipment List
Complete inventory of current and projected equipment with detailed specifications including dimensions, clearances, electrical requirements, water/gas/exhaust needs, and network connectivity.
3) Process Flow Documentation
Mapped workflows across both QC and CRO operations identifying opportunities for consolidation and optimization in the unified facility.
4) Hazardous Materials Management Plan
Comprehensive assessment of chemical, biological, and gas hazards with specifications for safe handling, storage, and disposal systems.
5) RFP Documentation
Detailed request for proposal materials that enabled accurate vendor evaluation and competitive bidding while reducing discovery costs.
6) Ongoing Design & Construction Support
Regular participation in design reviews, construction meetings, and quality assurance checks to ensure requirements were met throughout the build.
7) Regulatory Compliance Framework
Documentation demonstrating facility design adherence to Biosafety Level II, GMP, GLP, ISO 17025, and controlled substances regulations.
Lessons Learned
Requirements Definition is Everything
In laboratory facility design, the gap between scientific operations and architectural planning is where costly mistakes happen. Investing time upfront to comprehensively document requirements—in language architects can use directly—prevents expensive post-construction remediation. A missing floor drain or undersized electrical circuit is cheap to specify correctly but extraordinarily expensive to fix after build.
Technical Details Drive Project Success
Managing laboratory builds requires rigorous attention to the specifications of multiple complex systems simultaneously. The details matter: exhaust capacity for fume hoods, electrical phase requirements for autoclaves, floor drain locations for emergency showers. Missing even one specification can cascade into significant delays.
Consolidation Creates Strategic Value
Combining facilities is more than saving on rent—it’s an opportunity to fundamentally improve operations. Centralizing shared processes like media preparation and gas distribution creates efficiencies that improve both cost structure and operational reliability while positioning the organization for future growth.
Regulatory Compliance Must Be Built In
For regulated laboratory operations, compliance requirements should drive facility design from the beginning. Biosafety containment, quality system standards, and controlled substances regulations have specific facility implications that are far easier to incorporate during design than to retrofit later.
Future-Proofing Justifies Investment
Building capacity for planned expansions—even if not immediately implemented—is vastly more cost-effective than relocating again in five years. Infrastructure for additional capabilities (extra electrical capacity, pre-plumbed gas lines, designated expansion space) pays dividends as the organization grows.
Ready to Optimize Your Life Sciences Facility?
Whether you’re consolidating operations, expanding capabilities, or building from the ground up, laboratory and manufacturing facility design requires technical expertise that bridges science and construction. We ensure your requirements are translated into specifications that architects can execute—preventing costly mistakes and creating a facility optimized for your operations.
Terraforme Biosciences 