Manufacturing & Quality
Quality at GMPriority Pharma is governed through control of critical formulation and processing parameters, supported by in-house analytical characterisation and structured manufacturing execution from development through to commercial production.
Infrastructure for Controlled Liposomal Production
GMPriority Pharma operates a fully integrated UK facility combining liposomal development, manufacturing and quality oversight within a single operational environment.
This infrastructure is designed to support lipid-based systems from formulation through to commercial production, aligning development conditions with manufacturing processes and equipment constraints.
Core infrastructure includes:
- Class 7 cleanroom production environments supporting controlled liposomal processing
- GMP-aligned manufacturing systems with batch-level documentation and traceability
- FSSC ISO 22000-certified quality management systems
- Dedicated R&D laboratories supporting formulation development and scale-up
- Defined process transfer protocols aligned with production equipment and conditions
- In-house particle characterisation capability, including particle size distribution and dispersion behaviour analysis
Liposomal Process Control
Liposomal systems require control over lipid composition, process parameters and environmental conditions to achieve consistent particle size distribution, dispersion behaviour and stability.
At GMPriority Pharma, production protocols are designed to manage these variables across formulation and manufacturing, supporting:
→ Controlled particle size distribution and dispersion behaviour within defined ranges
→ Structural consistency across batches within specified process parameters
→ Stability under defined storage and handling conditions
→ Reproducible manufacturing output across production runs
This control is applied across both liquid and dry liposomal systems, supporting consistency in delivery behaviour as products transition from development into commercial manufacture.
VEREx®
Verification and Validation
VEREx® is GMPriority Pharma’s internal system for verification and validation of liposomal manufacturing processes.
It defines how critical formulation and process parameters are established, monitored and controlled across development, scale-up and commercial production.
Rather than operating as a standalone quality layer, VEREx® is applied directly to manufacturing execution, linking formulation design, process parameters and production control.
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VEREx® supports:
» Control of critical process parameters influencing particle size distribution, dispersion behaviour and structural integrity
» Verification of batch-to-batch consistency within defined acceptance ranges
» Structured documentation enabling full batch traceability
» Stability monitoring under defined storage and handling conditions
» Change control processes governing formulation and manufacturing adjustments
This framework operates within GMP and FSSC ISO 22000-aligned systems, extending beyond compliance to provide structured control over how liposomal systems are manufactured and reproduced at commercial scale.
Operational Control in Manufacturing
Manufacturing is governed through defined process parameters and monitored analytical outputs.
Particle size distribution and polydispersity index (PDI) measured across batches
Stability assessment under controlled storage environments
Batch records documenting critical process parameters and outcomes
These measurements support ongoing verification of system performance across development, scale-up and commercial production.
Verification in Practice
VEREx® integrates analytical verification within manufacturing execution, including:
- Monitoring of particle size distribution within defined acceptance ranges
- Batch-to-batch comparison of critical parameters
- Stability tracking across defined timepoints and storage conditions
- Documentation and traceability of all production variables
This structured verification supports early identification of variation and controlled response within manufacturing processes.
Scale & Continuity
Scale-up is managed through defined process transfer protocols, ensuring that formulation behaviour and critical process parameters are maintained as production moves from development to commercial manufacture.
Scientific oversight remains embedded within controlled production environments, supporting:
- Consistent batch output within defined process parameters
- Long-term supply stability supported by controlled production environments
- Reliable execution at commercial scale
Rather than treating scale as a capacity milestone, GMPriority Pharma approaches it as a controlled extension of development, where systems, parameters and processes are carried forward with defined continuity.
This approach supports the reliable manufacture of liposomal systems at commercial scale, with consistency, reproducibility and sustained supply.
Designed for Commercial Production
Manufacturing systems are designed to operate under real commercial conditions, including:
Defined batch sizes aligned with production equipment
Scheduled production within GMP-aligned environments
Ongoing supply supported by structured manufacturing planning
Documented process transfer from development into production
