On the Use of Temperature Measurements as a Process Analytical Technology (PAT) for the Monitoring of a Pharmaceutical Freeze-Drying Process [PDF]
Pharmaceutics, 2023 The measurement of product temperature is one of the methods that can be adopted, especially in the pharmaceutical industry, to monitor the freeze-drying process and to obtain the values of the process parameters required by mathematical models useful ...
Alberto Vallan +3 more
doaj +4 more sources
Process analytical technology (PAT) for biopharmaceuticals [PDF]
Biotechnology Journal, 2011 Process analytical technology (PAT), the regulatory initiative for building in quality to pharmaceutical manufacturing, has a great potential for improving biopharmaceutical production.
Jarka Glassey +6 more
core +8 more sources
Experimental design of a film flow cleaning rig equipped with in-line process analytical technology (PAT) tool for real-time monitoring [PDF]
HeliyonThe main purpose of this research was to develop an experimental film flow cleaning rig that can be combined with Process analytical technology (PAT) tools to reduce cleaning time and costs. Here, we show that the use of in-line UV–Vis was successful for
Marina Steiner-Browne +2 more
doaj +3 more sources
In-Line UV-Vis Spectroscopy as a Fast-Working Process Analytical Technology (PAT) during Early Phase Product Development Using Hot Melt Extrusion (HME) [PDF]
Pharmaceutics, 2018 This paper displays the potential of an in-line PAT system for early phase product development during pharmaceutical continuous manufacturing following a Quality by Design (QbD) framework.
Walkiria Schlindwein +5 more
doaj +4 more sources
Exploiting Fluorescent Reporter Molecules for Process Analytical Technology (PAT)
CHIMIA, 2009 Process Analytical Technology (PAT) launched by the U.S. Food and Drug Administration (FDA) aims to ensure the quality of pharmaceutical products. One important tool to obtain a deeper process understanding is the use of modern real-time process
Tobias Broger +3 more
doaj +4 more sources
Process Analytical Technology (PAT) Model Lifecycle Management [PDF]
Spectroscopy, 2023 Many applications of process analytical technologies (PAT) use spectroscopic measurements that are based on prediction models. The accuracy of the models can be affected by a number of factors such as aging equipment, slight changes in the active pharmaceutical ingredient (API) or excipients, or previously unidentified process variations.
Larry McDermott
openalex +2 more sources
Current PAT Landscape in the Downstream Processing of Biopharmaceuticals [PDF]
Analytical Science AdvancesProtein‐based therapeutics have revolutionized modern medicine, addressing complex diseases with unprecedented specificity and efficacy. The rising demand for biologics has driven the evolution of biomanufacturing practices to ensure consistent quality ...
Pavithra Sathiyapriyan +6 more
doaj +2 more sources
PROCESS ANALYTICAL TECHNOLOGY (PAT) IN PHARMACEUTICAL MANUFACTURING: A REVIEW
EPRA International Journal of Research & Development (IJRD)Process Analytical Technology (PAT) is a key concept in pharmaceutical manufacturing that involves the use of analytical techniques to monitor and control manufacturing processes in real-time. This review aims to provide an overview of PAT in pharmaceutical manufacturing, including its principles, applications, and benefits.
Sanjay Saravaiya +3 more
openalex +3 more sources
, 2020 Monoclonal antibodies (mAbs) are key molecules in biopharmaceutical manufacturing with important therapeutic use such as anticancer drugs. Mammalian cells serve as production hosts for mAbs. However, mammalian cell culture processes are complex and development timelines for new processes are long.
Sabrina Metze
openalex +3 more sources
Symposium on Process Analytical Technology (PAT) at ILMAC Lausanne 2018
CHIMIA, 2018 David Spichiger, Tobias Merz
doaj +5 more sources