Design of experiments (DoE) in pharmaceutical development

S N. Politis, P Colombo, G Colombo… - Drug development and …, 2017 - Taylor & Francis
At the beginning of the twentieth century, Sir Ronald Fisher introduced the concept of
applying statistical analysis during the planning stages of research rather than at the end of …

Hot-melt extrusion: from theory to application in pharmaceutical formulation

H Patil, RV Tiwari, MA Repka - Aaps Pharmscitech, 2016 - Springer
Hot-melt extrusion (HME) is a promising technology for the production of new chemical
entities in the developmental pipeline and for improving products already on the market. In …

[HTML][HTML] The future of pharmaceutical manufacturing sciences

J Rantanen, J Khinast - Journal of pharmaceutical sciences, 2015 - Elsevier
The entire pharmaceutical sector is in an urgent need of both innovative technological
solutions and fundamental scientific work, enabling the production of highly engineered …

Sol-gel silica nanoparticles in medicine: A natural choice. Design, synthesis and products

MC Gonçalves - Molecules, 2018 - mdpi.com
Silica is one of the most abundant minerals in the Earth's crust, and over time it has been
introduced first into human life and later into engineering. Silica is present in the food chain …

Development of a quantitative mass spectrometry multi-attribute method for characterization, quality control testing and disposition of biologics

RS Rogers, NS Nightlinger, B Livingston, P Campbell… - MAbs, 2015 - Taylor & Francis
Regulatory agencies have recently recommended a Quality by Design (QbD) approach for
the manufacturing of therapeutic molecules. A QbD strategy requires deep understanding at …

Continuous manufacturing in pharmaceutical process development and manufacturing

CL Burcham, AJ Florence… - Annual review of …, 2018 - annualreviews.org
The pharmaceutical industry has found new applications for the use of continuous
processing for the manufacture of new therapies currently in development. The …

PAT implementation on a mobile continuous pharmaceutical manufacturing system: real-time process monitoring with in-line FTIR and Raman spectroscopy

Y Miyai, A Formosa, C Armstrong… - … Process Research & …, 2021 - ACS Publications
The strategies and experimental methods for implementation of process analytical
technology (PAT) on the mobile pharmaceutical manufacturing system, Pharmacy on …

[HTML][HTML] Pharmaceutical crystallisation processes from batch to continuous operation using MSMPR stages: Modelling, design, and control

Q Su, ZK Nagy, CD Rielly - Chemical Engineering and Processing: Process …, 2015 - Elsevier
In pharmaceuticals manufacturing, the conversion of conventional batch crystallisations to
continuous mode has the potential for intensified, compact operation and more consistent …

Transforming nanomedicine manufacturing toward Quality by Design and microfluidics

S Colombo, M Beck-Broichsitter, JP Bøtker… - Advanced drug delivery …, 2018 - Elsevier
Nanopharmaceuticals aim at translating the unique features of nano-scale materials into
therapeutic products and consequently their development relies critically on the progression …

Using a material property library to find surrogate materials for pharmaceutical process development

MS Escotet-Espinoza, S Moghtadernejad, J Scicolone… - Powder technology, 2018 - Elsevier
Material properties are known to have a significant impact on pharmaceutical manufacturing
performance, particularly for solid product processes. Evaluating the performance of a …