Manufacturing
Manufacturing Excellence Through Material Lifecycle Management
Commercial manufacturing transforms promising molecules into life-changing medicines. This transition demands more than storage; it requires lifecycle management capabilities that match your production excellence. GXP-Storage® provides manufacturing solutions that ensure your products maintain quality from raw materials to patient delivery.
The Hidden Cost of Fragmented Manufacturing Material Management
Most life sciences companies manage their manufacturing materials across multiple storage providers, creating significant gaps in visibility and compliance.
Raw materials are stored in one location, finished products are stored elsewhere, and quality materials are scattered across additional providers. Each operates in isolation with siloed systems, inconsistent standards, and limited visibility.
Manufacturing executives consistently emphasise proximity requirements. A VP of Supply Chain at a leading biotech company notes that sometimes they need 24-hour turnaround times, which limits options to locations within a one-to-two-hour radius of the manufacturing or testing facilities. The hidden costs multiply quickly when materials are fragmented across distant providers.
Complete Manufacturing Material
Lifecycle Management Changes Everything
GXP-Storage eliminates fragmentation with truly integrated manufacturing lifecycle management. This isn’t just storage with a software layer. It’s a fundamentally different approach where every system, process, and team member aligns to support your complete manufacturing material lifecycle.
- RRaw materials, including APIs, excipients, and packaging components, across temperature ranges
- RProcessing aids and other production inputs with validated environmental controls
- RTest and calibration records, equipment logs, and quality assurance records
- RIntermediates, finished goods, retain with complete lot traceability
- RBatch records, product recalls, and legal hold materials for compliance
PURPOSE-BUILT FACILITIES
Our purpose-built, commissioned facilities with secure access-controlled environments provide millions of cubic feet of storage capacity across controlled ambient to cryogenic conditions that grow with you from discovery through development.
FULL VISIBILITY
Research materials and documentation can be visible through our proprietary GXP-Guardian®, the only system explicitly built for regulated material lifecycle management supported by a complete digital architecture.
CERTIFIED SOLUTIONS
From your first research sample to the day your commercial product ships globally, you maintain full visibility and control through a single, GAMP 5 and 21 CFR Part 11 validated system. Generate compliance documentation quickly. This is what industry leadership looks like.
cGMP Excellence That Scales
Manufacturing storage faces unique regulatory requirements that basic warehousing cannot address. Industry research confirms that cGMP compliance is table stakes for manufacturing storage, with companies expecting comprehensive capabilities to qualify as GMP storage locations.
Comprehensive cGMP Compliance
- Adherence with 21 CFR Part 210/211 requirements
- Robust Quality Management System and Standard Operating Procedures
- Comprehensive cleaning procedures prevent cross-contamination
- Environmental monitoring systems continuously track all storage conditions
- Security protocols protecting materials and intellectual property
- Audit trail generation supporting every product release decision
GXP-Storage has a solid inspection-ready posture and is GXP-compliant, so we have the ability to store both regulated research and manufacturing materials safely.
Director, Leading Biotech Company
Capacity That Scales With Success
Manufacturing success can challenge storage capacity, but our extensive capacity across controlled ambient to cryogenic conditions ensure you never face growth constraints.
- $Extensive storage capacity eliminates growth bottlenecks
- $Flexible configurations adapting to changing manufacturing needs
- $Future-ready facilities supporting long-term commercial success
- $Intelligent capacity management prevents mid-project relocations
Manufacturing Results That Matter
Our manufacturing storage solutions deliver measurable improvements supporting commercial success:
Operational Excellence
- Inventory optimisation reduces working capital requirements while ensuring availability
- Manufacturing efficiency through reliable material access, meeting urgent timelines
- Supply chain security with complete traceability from raw material to finished product
- Cost optimisation through transparent pricing and efficient operations
Compliance Advantage
- Regulatory submission support with comprehensive validated documentation
- Risk mitigation through proven cGMP quality systems
- Audit readiness, maintaining an inspection-ready posture continuously
Strategic Locations. Built Where Science Happens.
Our purpose-built facilities in Research Triangle Park, NC, and the UK’s Golden Triangle anchor us in the world’s most advanced life sciences ecosystems – offering operational and scientific advantages that accelerate progress
- $Proximity to leading CROs, analytical labs, and biotech innovators enables seamless collaboration and rapid response.
- $Concentrated life sciences expertise drives efficiency and insight.
- $Cost-effective operations help maximise research budgets.
- $Immediate material access keeps your timelines moving at the speed of discovery.
Trusted by the World’s Leading Life Sciences Organisations
In regulated material management, experience isn’t optional — it’s everything.
Our senior leadership team brings over a century of combined expertise who’ve supported more than 1,000 global life sciences partners, from discovery through commercial scale. That depth gives GXP-Storage unmatched insight into the operational and compliance challenges that define regulated research.
Research and QA leaders trust us because GXP-Guardian delivers what others can’t – a born-digital, audit-ready platform that can anticipate issues before they surface and prevents deviations before they occur.
Our purpose-built processes accelerate progress, ensure regulatory certainty by design, and reduce the total cost of lifecycle management — giving you confidence without compromise at every phase of development.
Technology That Transforms Manufacturing Management
GXP-Guardian provides manufacturing teams with comprehensive visibility and control across their complete material ecosystem. Unlike legacy systems that merely track locations, it provides manufacturing intelligence that optimises operations:
- $Material consumption tracking to prevent stockouts across all storage locations
- $Expiration date monitoring, minimising waste, and ensuring compliance
- $Usage pattern analysis optimising ordering and inventory levels across the ecosystem
- $ERP system integration synchronising data across your enterprise and all partners
The system delivers the transparency that procurement teams demand. As noted by industry executives concerned about pricing, our transparent systems ensure you see precisely what you’re paying for across all providers and understand the value delivered.
Start Your Manufacturing Transformation Today
Your manufacturing materials deserve better than fragmented storage.
Your team deserves better than constant vendor management.
Your stakeholders deserve better than compliance uncertainty.
To learn about how we can help you manage your regulated research and manufacturing material, download our information sheet.