news
WuXi STA opens its first oral solids continuous manufacturing line
Operation has begun for CRDMO WuXi STA's first continuous manufacturing line for oral solids, in Wuxi city, China.
List view / Grid view
Process Analytical Technologies (PAT)
article
An Annex 1 and Pharma 4.0 perspective on water quality
Pharma 4.0 is coming and is further driven by the recent update of the EU GMP Annex 1 regarding manufacturing of sterile medical products, setting new regulatory expectations in all manufacturing processes. Here, Isabella Jul-Jørgensen from the University of Denmark focuses on sterile water quality and how the new requirements…
news
Validating FTIR for rapid cleaning verification
Researchers simulated the effect of surface roughness on Fourier-transform infrared (FTIR) spectroscopy, developing guidance for validating the technique for rapid cleaning verification.
news
Developing an adaptive auto-synthesiser
EPR highlights the use of HPLC and FTIR in the creation of an auto-synthesiser that can flexibly perform critical actions such as quenching, purging and dosing reagents.
whitepaper
Whitepaper: PAT leads the way in the adoption of continuous manufacturing processes
Martin Gadsby, CEO & Director at Optimal Industrial Technologies and Flavio Belvedere, Co-Founder of ABCS Srl, look at the benefits of PAT and the aspects to consider when deploying it.
news
Multi-angle light scattering: PAT for polysaccharide conjugate vaccines
EPR highlights the implementation of multi angle light scattering (MALS) as a process analytical technology (PAT) tool for the real-time monitoring of protein-polysaccharide conjugate fraction molar mass.
news
UV-based PAT could enable continuous protein purification
A multi-wavelength UV-based process analytical technology (PAT) could significantly reduce downstream protein purification timelines.
news
Evolving real-time dissolution prediction and product release
EPR highlights the development of a model to predict dissolution of sustained release formulations based on Raman process analytical technology (PAT) sensor data that could enable real-time release testing.
news
Advancing autonomous API reaction optimisation
A novel flow reactor platform was able to self-optimise a range of variables within a multi-step reaction by leveraging process analytical technologies (PAT) and chemometric models.
whitepaper
Product hub: Simple process Raman with Ramina
The Thermo Scientific™ Ramina™ Process Analyzer is a compact and portable Raman spectrometer. This all‑in-one system is purpose-built for rapid deployment, ease of use, and scalability in markets where time-to-results is critical.
article
Progress in the implementation of biofluorescent particle counters
Despite the promise of biofluorescent particle counters (BFPCs) as an alternative and rapid microbiological method and process analytical technology, their implementation thus far has predominantly occurred in non-GMP environments. In this article, EPR’s Hannah Balfour explores the reasons, with comment from Mike Russ, Senior Manager, Head of QCLS/Analytical Science and…
news
Machine learning model enables adventitious agent detection in cell cultures
Researchers have developed a rapid, label-free process analytical technology, called the anomaly detection model, to monitor microbial contamination in cell cultures in near-real-time.
news
Could process data offer a different approach for predicting quality?
A data collection study provides a product quality dataset that could form the basis of advanced analytical models to predict final product quality.
whitepaper
Future of QA/QC for Complex Biologics Whitepaper
Download this whitepaper to discover the latest developments and research in QA/QC for biologic therapies via exclusive articles, interviews and application notes.
news
Miniaturisation helps overcome limitations of PAT, say experts
Researchers review how miniaturised process analytical technologies (PAT), microfluidic affinity assays and microchip capillary electrophoresis, enhance bioprocess monitoring and control.
