Research landscape analysis for quality in Pharma 4.0 era

RV Barenji, RE Hariry, D Demirkol, TU Daim - Technology in Society, 2024 - Elsevier
This study focuses on the production phase of drug development and examines approaches
and their progress indicators for enhancing the quality of pharmaceutical products and …

The use of UV-Vis spectroscopy in bioprocess and fermentation monitoring

J Roberts, A Power, J Chapman, S Chandra… - Fermentation, 2018 - mdpi.com
Real-time analytical tools to monitor bioprocess and fermentation in biological and food
applications are becoming increasingly important. Traditional laboratory-based analyses …

[HTML][HTML] Multi-sensor spectral fusion to model grape composition using deep learning

S Gutiérrez, J Fernández-Novales, T Garde-Cerdán… - Information …, 2023 - Elsevier
Spectral instruments can be useful for the rapid assessment of chemical compounds in
different targets, and their use have been already reported for the modeling of grape …

Dropwise additive manufacturing of pharmaceutical products for amorphous and self emulsifying drug delivery systems

E Içten, HS Purohit, C Wallace, A Giridhar… - International journal of …, 2017 - Elsevier
The improvements in healthcare systems and the advent of the precision medicine initiative
have created the need to develop more innovative manufacturing methods for the delivery …

Comprehensive evaluation of a data driven control strategy: Experimental application to a pharmaceutical crystallization process

M Öner, FCC Montes, T Ståhlberg, SM Stocks… - … Research and Design, 2020 - Elsevier
In this contribution, a data-driven control approach was developed and applied
experimentally to a pharmaceutical batch cooling crystallization process. In this approach, a …

Improved understanding of cefixime trihydrate reactive crystallization and process scale-up with the aid of PAT

S Yu, Y Zhang, XZ Wang - Organic Process Research & …, 2019 - ACS Publications
Reactive crystallization to make cefixime trihydrate crystals via cefixime disodium reacting
with hydrogen chloride was investigated using ATR FTIR and an online imaging instrument …

Multi-impurity adsorption model for modeling crystal purity and shape evolution during crystallization processes in impure media

A Borsos, A Majumder, ZK Nagy - Crystal Growth & Design, 2016 - ACS Publications
The impurity effect on the crystal properties, such as particle size and shape distribution, is
significant, having significant impact on the downstream processes as well as on the product …

In situ monitoring of cocrystals in formulation development using low-frequency Raman spectroscopy

T Otaki, Y Tanabe, T Kojima, M Miura, Y Ikeda… - International journal of …, 2018 - Elsevier
In recent years, to guarantee a quality-by-design approach to the development of
pharmaceutical products, it is important to identify properties of raw materials and excipients …

Raman spectroscopy as process analytical tool in downstream processing of biotechnology

YK Lin, HY Leong, TC Ling, DQ Lin, SJ Yao - Chinese Journal of Chemical …, 2021 - Elsevier
Downstream processing or product recovery plays a vital role in the development of
bioprocesses. To improve the bioprocess efficiency, some unconventional methods are …

Small-volume continuous manufacturing of merestinib. Part 2. Technology transfer and cGMP manufacturing

BJ Reizman, KP Cole, M Hess, JL Burt… - … Process Research & …, 2019 - ACS Publications
Technology transfer of a small volume continuous (SVC) process and Current Good
Manufacturing Practices (cGMP) manufacturing of merestinib are described. A hybrid batch …