Upscaling from Feasibility to Commercial Production

In the development and scale-up of a pharmaceutical dosage form, each stage plays a crucial role in laying the foundation for successful commercialization. Our focus in capsule manufacturing included:

 • Formulation Development and Active Ingredient Optimization: Each component was meticulously selected and optimized to ensure bioavailability, stability, and therapeutic efficacy.

 • Laboratory Experiments and Pilot Batch Production: Comprehensive in-vitro and in-vivo studies were conducted to validate formulation feasibility, providing a solid basis for scaling.

 • Scalable Process Development: We adapted lab-scale processes to manufacturing scale, focusing on equipment specifications and process robustness to ensure production consistency.

 • Process Optimization and Parameter Validation: Critical process parameters (CPPs) were fine-tuned and validated to guarantee a reproducible and robust manufacturing workflow.

 • Detailed Simulation Studies and Production Line Design: Using advanced simulation models, we conducted in-depth calculations and process mapping to design an optimized and efficient production line.

 • Commercial Scale-Up and Market Launch: We successfully implemented and commissioned the manufacturing line on-site at the client’s facility, resulting in a GMP-compliant, market-ready pharmaceutical product.

Through each stage, we maintained a shared commitment to delivering a high-quality, reliable product, seamlessly transforming our feasibility studies into a fully operational commercial solution ready for market launch.

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