Modernizing Pharmaceutical Manufacturing: from Batch to Continuous Production

Abstract

The Food and Drug Administration (FDA) regulates pharmaceutical drug products to ensure a continuous supply of high-quality drugs in the USA. Continuous processing has a great deal of potential to address issues of agility, flexibility, cost, and robustness in the development of pharmaceutical manufacturing processes. Over the past decade, there have been significant advancements in science and engineering to support the implementation of continuous pharmaceutical manufacturing. These investments along with the adoption of the quality-by-design (QbD) paradigm for pharmaceutical development and the advancement of process analytical technology (PAT) for designing, analyzing, and controlling manufacturing have progressed the scientific and regulatory readiness for continuous manufacturing. The FDA supports the implementation of continuous manufacturing using science-and risk-based approaches.

Scaled-up preparation of drug-loaded electrospun polymer fibres and investigation of their continuous processing to tablet form

“…This is proven by the fact that the reflection Raman model of blends was found to be the most precise one. Real time detection of crystalline traces by a non-destructive analytical technique such as NIR or Raman spectroscopy is of great importance regarding new pharmaceutical trend, continuous manufacturing [60]. A further goal of the future is to enhance the prediction power of the models and to correlate NIR and Raman spectra with the dissolution and achieve real-time release testing.…”

The Future of Pharmaceutical Manufacturing Sciences

“…However, in real life, using all this information often causes more regulatory obstacles than improved quality or real financial benefit. It has to be noted that there is regulatory support for the implementation of CM using science‐ and risk‐based approaches …”

Optimized continuous pharmaceutical manufacturing via model-predictive control

“…[1,2]. Continuous manufacturing is advantageous in many aspects: In-line monitoring of critical quality attributes (CQA) is a prerequisite, 5 leading to reduced product variability and consequently a reduction in product waste.…”