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The pharma industry’s adaptation to Industry 4.0 has been slow, due to the extensive regulatory requirements imposed on manufacturers. However, regulatory agencies are starting to embrace movement towards more rapid/automated systems, as illustrated in the revised EU GMP Annex 1, which entered into force in August. Here, Isabella Jul-Jørgensen from the Technical…
A report has shown that growing demand for accurate identification of pharmaceutical raw materials is anticipated to boost the global Raman spectroscopy market.
Researchers have described how a process analytical technologies (PAT) fluorescent dye (FD)-based microfluidic sensor facilitated immediate feedback and control of process parameters for continuous downstream processing.
EPR Issue 4 includes articles on fridge-free vaccines, dry powder drug delivery, Annex 1, contamination control strategy and more.
A study incorporating new methodologies has described a stratified sampling procedure used for analyte response evaluation in pharmaceutical migration studies.
To address the perceived barrier to entry for rapid microbiological methods, new validation packages are now available for Celsis® rapid microbial detection.
Nitrosamine genotoxins in several pharmaceuticals has led to monitoring of manufacturing practices for products considered at risk.
Nitrosamine impurities have become a concern in the bio/pharmaceutical industries, due to their carcinogenic properties and presence in medications.
Discover the benefits of liquid-filled capsules for the formulation of highly potent APIs and drugs that benefit from slow or extended release.
Experts at Amgen have highlighted a micro sequential injection (µSI) process analyser and automatic assay preparation platform (A2P2) as an autonomous process analytical technology (PAT) platform to enable rapid testing and release of biopharmaceutical products.
2 August 2023 | By Metrohm
This webinar highlights the importance of impurity testing in pharmaceuticals and how ion chromatography can provide excellent sensitivity and selectivity when testing for ionic impurities.
Transferring analytical methods between companies is often a challenging, time-consuming manual process. In this Q&A, Dr Birthe Nielsen, Project Lead at The Pistoia Alliance, speaks about an ongoing project to digitally transfer HPLC data between different vendors.
Altasciences has published an ebook sharing comprehensive information about testing biomarkers of immunomodulation as part of your drug development program.
Altasciences’ Proactive Drug Development can accelerate the development of small molecules by up to 40%, from lead identification to clinical POC.
How the GMP requirements affect the manufacturing of sterile medicinal products from European Member States and products imported from outside Europe.
