article
Your endotoxin experts
A new age of sustainability: discover how ACC’s PyroSmart NextGen® recombinant Cascade Reagent (rCR) enhances bacterial endotoxin testing (BET).
List view / Grid view
QA/QC
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…
article
Microbiology In-Depth Focus 2022
Features in this in-depth focus review the advances in bacterial genome sequencing and its role in pharmaceutical microbiology, as well as key considerations for when implementing and validating recombinant Factor C (rFC) endotoxin testing. Plus, coverage of how proposed US pharmaceutical regulation could impact European companies, in-house lentiviral vector manufacturing…
article
European Pharmaceutical Review Issue 5 2022
In EPR Issue 5, articles explore the role of whole genome sequencing in pharmaceutical microbiology, the formulation of oral taxanes and the potential for tackling immune-mediated disease with CAR T regulatory cells. Plus, coverage of how proposed US pharmaceutical regulation could impact European companies, in-house lentiviral vector manufacturing and much…
news
Microbial identification market valued at $10.7 billion by 2032
Technological innovations like automation and real-time analysis, as well as industry collaboration are anticipated to become key tools in the global microbial identification systems market going forward.
news
Large bacterial culture volumes can be filtered without centrifuge
The study observed that using a modified vacuum filtration system assisted in the filtration of large volumes of bacterial cultures, removing the need for centrifuges.
news
Quantifying proteins en masse using coulometric mass spectrometry
Coulometric mass spectrometry (CMS) fully quantities proteins without using traditional lab sample testing standards, promising faster vaccine and drug advancement.
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
Nitrogen dioxide for sterilisation of protein-filled polymer-based syringes
Nitrogen dioxide (NO2) gas found not to ingress and cause protein degradation when sterilising polymer-based prefilled syringes (P-PFSs), according to study.
news
Enabling multi-dimensional biotherapeutic analysis
EPR highlights the development of a simple, flexible two-dimensional liquid chromatography-native mass spectrometry method for the in-line analysis of biotherapeutics.
news
HPLC-MS/MS for NDMA impurity determination in sartans
EPR summarises the development of a HPLC method for the detection, separation and quantification of N-nitrosodimethylamine (NDMA) in both olmesartan API and finished formulations.
news
Medicinal cannabis monograph proposed by US Pharmacopeia
A monograph outlining the analytical methods and acceptance criteria for cannabis chemotypes has been released for comment by USP’s Herbal Medicines Compendium.
news
HPLC determination of common cold formulations
EPR highlights a high-performance liquid chromatography (HPLC) method which enables the detection of both chlorpheniramine maleate and ibuprofen in formulation.
news
AbbVie Cork facility €60 million expansion
The Irish biopharmaceutical plant was given a special update for its pivotal 20th anniversary, expanding the site to offer its future workforce training in new technology.
whitepaper
Guide: Rapid microbial detection methods
Plate counting falls short in reducing the risk of contamination during pharmaceutical production. Learn more about rapid microbiological methods.
