Stability Storage & Testing Services
Integrated Stability Storage and Analytical Testing Services For Global Product Approval
Supporting IND, NDA, 510 (k), BLA, ANDA, and Commercial Programs Across Small Molecules, Peptides, and Biologics
Executive Overview
SmaBio Labs provides GMP-compliant stability storage services and pharmaceutical stability testing to support drug substance, drug product and device development across preclinical, clinical, and commercial stages. Our stability studies are designed and executed in accordance with ICH (International Council for Harmonization) guidelines, including Q1A(R2) (drug products), Q1B (photostability), Q1D (bracketing and matrixing), Q1E (evaluation of stability data), and Q5C (biologics), ensuring alignment with current global regulatory expectations.
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Stability Storage Capabilities
Fully qualified stability chambers capable of supporting various ICH climatic zones and standard study conditions for both small molecules and biologics.
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Accelerated stability studies: 40°C / 75% RH
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Intermediate conditions: 30°C / 65% RH
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Long Term: 25°C / 60% RH
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Other: 30°C / 75% RH
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Refrigerated storage: 2–8°C (per ICH Q1A(R2) and Q5C)
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Frozen storage: -20°C, -70°C (as required for biologics)
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Photostability testing: per ICH Q1B
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Freeze/Thaw Studies
All chambers are temperature and humidity mapped, with ongoing qualification to ensure consistent performance across all conditions.
Infrastructure includes:
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24/7 environmental monitoring with calibrated probes
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Alarm systems with defined escalation procedures
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Generator Systems
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Electronic data systems compliant with 21 CFR Part 11
Stability Study Management
Stability program management services support the full lifecycle of ICH stability studies:
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Protocol development aligned with ICH Q1A(R2) (small molecules) and ICH Q5C (biologics)
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Bracketing and matrixing designs per ICH Q1D
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Sample receipt, inventory control, and chain-of-custody tracking
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Stability timepoint scheduling (e.g., 0, 1, 2, 3, 6, 9, 12, 18, 24, 36 months)
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Coordinated analytical testing services at each pull point
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Statistical evaluation and reporting aligned with ICH Q1E
These services are structured to support IND, NDA, ANDA, and BLA submissions with complete, audit-ready datasets.
Analytical Testing Capabilities
GMP stability testing uses validated, stability-indicating methods suitable for both drug substances and drug products, including small molecules and biologics.
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HPLC/UPLC analysis for assay and impurity profiling
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Dissolution testing for drug products
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Custom dissolution for drug-device combination products
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Forced degradation studies to establish stability-indicating methods (ICH Q1A(R2))
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Physicochemical characterization (pH, osmolality, viscosity, appearance)
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Container closure compatibility studies
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Extractables & Leachable Studies
Method development, transfer, and validation are performed in accordance with ICH Q2(R2) and current regulatory expectations.
Quality & Regulatory Compliance
SmaBio Labs operates under a robust quality system supporting GMP stability studies across global markets. Our operations align with:
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U.S. Food and Drug Administration (21 CFR Parts 210, 211, and 11)
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European Medicines Agency guidelines
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ICH quality guidelines (Q1–Q14 series, including Q1A(R2) and Q5C)
Core quality features include:
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Data integrity practices (ALCOA+)
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Audit trails and secure electronic records
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Deviation, CAPA, and change control systems
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Inspection readiness and internal audit programs
Applications
Our pharmaceutical stability testing services support:
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Drug substances (APIs) and drug products (ICH Q1A(R2))
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Biologics and biosimilars (proteins, peptides, monoclonal antibodies) per ICH Q5C
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Clinical trial materials (Phase I–III)
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Post-approval stability commitments
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Global registration programs requiring multi-zone (I–IVb) stability data
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Packaging and container closure system evaluations
SmaBio Labs approach to stability testing integrates ICH stability zones, stability-indicating analytical methods, and risk-based study design. This ensures that stability data generated at SmaBio Labs supports global regulatory submissions and long-term product lifecycle management for both small molecules and biologics.