Product formulation from lab scale to commercial size – Proof of Concept (POC) to a Pilot Scale and finally to Commercial Scale

Lab → Pilot → Commercial per ICH Q8/Q10

Overview Service

Capzerpharma Manufacturing scales oral solid formulations from lab proof-of-concept through pilot exhibit batches to full commercial production in our 20,000 sq. ft. U.S. GMP facility. Our integrated platform supports Empagliflozin tablets and Gabapentin capsules with high-shear granulation, compression, and coating validation for ANDA approval and market supply.

Scale-Up Stages

Progressive scale-up maintains critical quality attributes.

Lab POC (grams): Manual blending, early dissolution profiling.
Pilot Scale (kg): High-shear granulator, FBD, tablet press for BE studies.
Commercial Scale: Multi-station presses, automated coating for 100,000+ units.

Process Optimization

QbD principles ensure reproducibility across scales.

Scale factors: Impeller speed, drying endpoints, compression force.
PAT monitoring: NIR for moisture, tablet weight variation <2% RSD.
Validation: 3 consecutive batches at 100–120% scale.

Key Equipment Progression

Scale	Equipment	Batch Size
Lab	V-blender, manual press	100g–1kg
Pilot	High-shear granulator, FBD	5–50kg
Commercial	30-station press, pan coater	100–500kg

Benefits for Partners

Partners transition Empagliflozin from POC to commercial supply within 12 months from our PAI-ready facility, achieving first-pass validation and rapid market entry.

Other Service

Need for help?

Our expert team is here to support you with reliable pharmaceutical testing, analytical solutions, and regulatory guidance. Whether you have a query or need a customized service, we’re ready to assist you at every step.