Results 21 to 30 of about 128,853 (246)

Understanding Pharmaceutical Quality by Design [PDF]

, 2016
This review further clarifies the concept of pharmaceutical quality by design (QbD) and describes its objectives. QbD elements include the following: (1) a quality target product profile (QTPP) that identifies the critical quality attributes (CQAs) of ...
Amidon, Gregory, Hoag, Stephen W., Khan, Mansoor A., Polli, James, Raju, Gokaraju K, Woodcock, Janet, Yu, Lawrence X.   +6 more
core   +1 more source

Advances in Twin-Screw Granulation Processing

Pharmaceutics, 2021
Twin-screw granulation (TSG) is a pharmaceutical process that has gained increased interest from the pharmaceutical industry for its potential for the development of oral dosage forms.
Uttom Nandi, Vivek Trivedi, Steven A. Ross, Dennis Douroumis   +3 more
doaj   +1 more source

Raman Spectroscopy as a PAT-Tool for Film-Coating Processes: In-Line Predictions Using one PLS Model for Different Cores

Pharmaceutics, 2020
Although Raman spectroscopy has been described as a potential process analytical technique for tablet coating, it has rarely been transferred from academic studies to commercial manufacturing applications.
Juliana Radtke, Hubertus Rehbaum, Peter Kleinebudde   +2 more
doaj   +1 more source

Removal of benzaldehyde from a water/ethanol mixture by applying scavenging techniques

Green Processing and Synthesis, 2017
A presence of carbonyl compounds is very common in the food industry. The nature of such compounds is to be reactive and thus many products involve aldehydes/ketones in their synthetic routes.
Mitic Aleksandar, Skov Thomas, Gernaey Krist V.   +2 more
doaj   +1 more source

Machine learning and metabolic modelling assisted implementation of a novel process analytical technology in cell and gene therapy manufacturing

Scientific Reports, 2023
Process analytical technology (PAT) has demonstrated huge potential to enable the development of improved biopharmaceutical manufacturing processes by ensuring the reliable provision of quality products.
Thomas Williams, Kevin Kalinka, Rui Sanches, Greg Blanchard-Emmerson, Samuel Watts, Lee Davies, Carol Knevelman, Laura McCloskey, Peter Jones, Kyriacos Mitrophanous, James Miskin, Duygu Dikicioglu   +11 more
doaj   +1 more source

Texture analysis as a tool to study the kinetics of wet agglomeration processes [PDF]

, 2015
In this work wet granulation experiments were carried out in a planetary mixer with the aim to develop a novel analytical tool based on surface texture analysis.
Codemo, Carlo, Franceschinis, Erica, Realdon, Nicola, Riccardo, Artoni, Santomaso, ANDREA CLAUDIO, Silvia, Nalesso   +5 more
core   +4 more sources

Oscillatory flow reactors (OFRs) for continuous manufacturing and crystallization [PDF]

, 2015
Continuous crystallization is an attractive approach for the delivery of consistent particles with specified critical quality attributes (CQAs), which are attracting increased interest for the manufacture of high value materials, including fine chemicals
Briggs, Naomi E. B., Brown, Cameron J., Clark, Catriona A., Florence, Alastair J., McGlone, Thomas, Sefcik, Jan   +5 more
core   +1 more source

Analytical Quality by Design Approach to Test Method Development and Validation in Drug Substance Manufacturing

Journal of Chemistry, 2015
Pharmaceutical industry has been emerging rapidly for the last decade by focusing on product Quality, Safety, and Efficacy. Pharmaceutical firms increased the number of product development by using scientific tools such as QbD (Quality by Design) and PAT
N. V. V. S. S. Raman, Useni Reddy Mallu, Hanimi Reddy Bapatu   +2 more
doaj   +1 more source

Diamond-Coated Silicon ATR Elements for Process Analytics

Sensors, 2021
Infrared attenuated total reflection (ATR) spectroscopy is a common laboratory technique for the analysis of highly absorbing liquids or solid samples.
Nicolai Arndt, Carsten Bolwien, Gerd Sulz, Frank Kühnemann, Armin Lambrecht   +4 more
doaj   +1 more source

Challenges and Opportunities of Implementing Data Fusion in Process Analytical Technology—A Review

Molecules, 2022
The release of the FDA’s guidance on Process Analytical Technology has motivated and supported the pharmaceutical industry to deliver consistent quality medicine by acquiring a deeper understanding of the product performance and process interplay.
Tibor Casian, Brigitta Nagy, Béla Kovács, Dorián László Galata, Edit Hirsch, Attila Farkas   +5 more
doaj   +1 more source