article
Endotoxin standards: reflection and recommendation
Dr Radhakrishna Tirumalai and Karen Zink McCullough reflect on the recent opportunity to update the user requirements document relating to reference endotoxin standards.
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QA/QC
news
Pharma’s attitudes on AI revealed
Artificial intelligence (AI) is generally being embraced in the pharma and life science sectors, but concerns around data accuracy and transparency remain, a new survey reveals.
webinar
Simplifying complex dosage forms with advanced encapsulation
15 July 2024 | By ACG Worldwide
This webinar explores the unique manufacturing challenges of multi-formulation capsules and how these dosage forms can enhance treatment efficacy and patient compliance.
webinar
Unmasking the unknown: how mass spectrometry delivers accurate identifications
15 July 2024 | By Nelson Laboratories
In this webinar, learn more about advanced techniques like mass spectrometry which can help identify unexpected impurities in drug substances and drug products.
news
Advanced techniques fuelling demand for liquid chromatography reagents
The versatility of liquid chromatography is propelling demand for high-quality chromatography reagents, the report stated.
article
Using rack systems to reduce thermal interactions between vials during freezing
Formulation experts from Polytechnic of Turin, Italy, discuss the impact of freeze-drying on the integrity and stability of pharmaceuticals and how mathematical modelling can improve understanding of the freezing process.
article
Cleanroom microbiology: single-temperature incubation for EM
Single-temperature incubation has been discussed for a long time in the pharmaceutical industry but only a few sites have implemented this system. Here, Guillaume Pinon, Head of the Microbiology Lab at Servier, discusses the use of single-temperature incubation in an aseptic production facility, outlining the regulatory considerations, strategic approach, challenges…
news
Optimising reverse-phase chromatography for molnupiravir production
The research offers insight into optimising chromatographic separation outcomes through precise control of measures such as flowrate and column length, supporting potential for drug development.
whitepaper
Application note: Automated nucleic acid amplification assay for mycoplasma detection in cell and gene therapy products
Ambili Menon, Pharma Quality Control, bioMérieux Inc. addresses the task of microbiological testing for advanced therapeutic medicinal products.
whitepaper
Application note: Validating recombinant cascade reagents in 3 simple steps
Endotoxin testing continues to evolve alongside the industry’s need for more sustainable methods that reduce ecological impact. Nicola Reid, Associate Director of Endotoxin Products, Charles River Labs, reflects on these developments which are driven by the 3Rs (replacement, reduction and refinement).
article
Guide to Data Integrity 2024
In this Guide to Data integrity articles explore the role of data integrity in CCS, AI and ML as well as biopharma manufacturing.
article
QA/QC Microbiology In-Depth Focus 2024
This in-depth focus features articles on single temperature incubation, endotoxin standards and aseptic connections in pharmaceutical manufacturing.
article
European Pharmaceutical Review Issue 3 2024
European Pharmaceutical Review Issue 3 includes articles on microbiology, downstream bioprocessing and drug development. Register your details now to download this exclusive content.
news
New US fill finish facility receives $4.1 billion investment
Novo Nordisk plans to allocate $6.8 billion towards production to expand its overall US manufacturing capacity.
podcasts
EPR Podcast Episode 26 – Navigating Nitrosamine Impurities – Jason Brown, Adare Pharma Solutions
In this podcast, Jason Brown, Senior Manager, Analytical Sciences, R&D, Adare Pharma Solutions, discusses the current landscape and the best approaches for mitigating contamination and detecting nitrosamines.
