STORAGE / CHANGE / EVIDENCE
Stability Storage & Testing
Understand how your product changes over time.
Connect study design, controlled storage and analytical testing around the product attributes that need to be followed.
PRODUCTS & MATERIALS
Small molecules, peptides, biologics and medical devices, with conditions selected for the product and study.
DEFINE YOUR SCOPE
Product fit, methods, material requirements and deliverables are agreed through technical review.
CONNECT THE QUESTION TO THE WORK
A scientific starting point
Identify the scientific need, explore the relevant offerings and bring your product question to a technical discussion.
Refrigerated and frozen conditions
Analytical time-point testing
Study management & documentation
METHODS & CAPABILITIES
Selection is guided by your product, scientific question and agreed scope.
Supporting IND, NDA, 510(k), BLA, ANDA, and Commercial Programs Across Small Molecules, Peptides, and Biologics
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.
Stability Storage Capabilities
Fully qualified stability chambers capable of supporting various ICH climatic zones and standard study conditions for both small molecules and biologics.
All chambers are temperature and humidity mapped, with ongoing qualification to ensure consistent performance across all conditions.
- Accelerated stability studies: 40°C / 75% RH
- Intermediate conditions: 30°C / 65% RH
- Long Term: 25°C / 60% RH
- Other: 30°C / 75% RH
- Refrigerated storage: 2–8°C (per ICH Q1A(R2) and Q5C)
- Frozen storage: -20°C, -70°C (as required for biologics)
- Photostability testing: per ICH Q1B
- Freeze/Thaw Studies
Infrastructure includes:
- 24/7 environmental monitoring with calibrated probes
- Alarm systems with defined escalation procedures
- Generator Systems
- Electronic data systems compliant with 21 CFR Part 11
Stability Study Management
Stability program management services support the full lifecycle of ICH stability studies:
These services are structured to support IND, NDA, ANDA, and BLA submissions with complete, audit-ready datasets.
- Protocol development aligned with ICH Q1A(R2) (small molecules) and ICH Q5C (biologics)
- Bracketing and matrixing designs per ICH Q1D
- Sample receipt, inventory control, and chain-of-custody tracking
- Stability timepoint scheduling (e.g., 0, 1, 2, 3, 6, 9, 12, 18, 24, 36 months)
- Coordinated analytical testing services at each pull point
- Statistical evaluation and reporting aligned with ICH Q1E
Analytical Testing Capabilities
GMP stability testing uses validated, stability-indicating methods suitable for both drug substances and drug products, including small molecules and biologics.
Method development, transfer, and validation are performed in accordance with ICH Q2(R2) and current regulatory expectations.
- HPLC/UPLC analysis for assay and impurity profiling
- Dissolution testing for drug products
- Custom dissolution for drug-device combination products
- Forced degradation studies to establish stability-indicating methods (ICH Q1A(R2))
- Physicochemical characterization (pH, osmolality, viscosity, appearance)
- Container closure compatibility studies
- Extractables & Leachables Studies
Quality & Regulatory Compliance
SmaBio Labs operates under a robust quality system supporting GMP stability studies across global markets. Our operations align with:
- U.S. Food and Drug Administration (21 CFR Parts 210, 211, and 11)
- European Medicines Agency guidelines
- ICH quality guidelines (Q1–Q14 series, including Q1A(R2) and Q5C)
Core quality features include:
- Audit trails
- Deviation, CAPA, and change control systems
- Inspection readiness and internal audit programs
Applications
Our pharmaceutical stability testing services support:
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.
- Drug substances (APIs) and drug products (ICH Q1A(R2))
- Biologics and biosimilars (proteins, peptides, monoclonal antibodies) per ICH Q5C
- Clinical trial materials (Phase I–III)
- Post-approval stability commitments
- Global registration programs requiring multi-zone (I–IVb) stability data
- Packaging and container closure system evaluations
THE QUESTION BEFORE THE TECHNIQUE
What does your product need us to understand?
- What changes under the proposed storage conditions?
- Which time points and endpoints will inform the product decision?
FROM OBSERVATION TO DECISION
What can the work help you decide?
Use trends across agreed conditions and time points to inform the next study or development decision.
CLARITY IN THE OUTPUT
What could your report include?
The proposal defines the actual documents, interpretation and review discussions included in your project.
- Agreed objective, sample identification and study scope
- Methods and conditions relevant to the work performed
- Results, observations and interpretation within the agreed scope
- Limitations, deviations and open questions where applicable
- Review discussion and next-step considerations if included in the proposal
PREPARE FOR TECHNICAL REVIEW
What helps us assess fit.
- Product or material type and development stage
- Scientific question, existing methods and available records
- Material quantities and intended use
- Target milestones and reporting requirements
AGREE THE OUTPUTS
Proposed deliverables.
- Agreed protocol and testing schedule
- Time-point analytical results
- Trend evaluation and study reporting
The final scope and deliverables are defined in the agreed proposal.