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New technologies are awaiting implementation by the pharmaceutical industry to improve and optimise processes, but as they are not compendial and may require lengthy approval processes, their adoption as a replacement for a compendial method is slow, if at all possible. Though the industry is still contemplating how to unlock…
Authors Edwin van den Heuvel, Maliheh Heidari, Kathrin Möllenhoff and Pieta IJzerman-Boon compare statistical analysis methods for determining comparable accuracy of alternate and compendial microbiological methods.
Robust sterility testing protocols are essential to protect patients, medicine supply chains and manufacturers’ bottom lines. But how do companies build successful sterility processes?
Articles in this in-depth focus discuss how you can compare the accuracy of alternate and compendial micro methods and explore the use of RMM to enhance microbial control alongside compendial methods.
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.
In this issue experts explore the development of targeted protein degradation drugs, how potential legislative changes may impact the EU and selecting the right downstream process for bi-specific antibodies. Also featured in this journal, how RMM can enable efficient shutdown recovery, five critical areas for data integrity in life sciences…
Here, EPR summarises the key points of Tim Sandle’s recent review of mycoplasma risks, detection and eradication techniques for cell cultures.
Researchers have identified, for the first time, a sensitive, low-risk, closed-system for the detection of fungal contaminants in cell and gene therapy (CGT) products.
According to a recent paper, by specifying equipment surface roughness as well as finish, pharmaceutical manufacturers can limit microbial attachment.
Are environmental isolates truly beneficial in qualifying microbiological methods? Here EPR summarises Tim Sandle’s recent paper on the debate.
Discover why Merck’s new MAS-100 Atmos® compressed gas sampler should be your go to for detecting microbial contamination…
Find out how SGS’s high-quality analytical testing solutions could benefit all phases of your drug development programmes, from discovery through commercialisation.
Here, EPR summarises Dr William Whyte’s guidance for formally selecting cleanroom monitoring locations and action levels.
Welcome to European Pharmaceutical Review’s Guide to Testing. In this edition, Oliver Großgart, Plant Safety Expert at TÜV SÜD Industrie Service GmbH, discusses the benefits of leveraging acoustic emission testing to identify faults in compressed air pressure vessels, and Associates of Cape Cod and SGS Health Science showcase their services,…
WuXi Biologics awarded the Bioprocessing Excellence in Viral Clearance and Safety accolade for the second time at the Asia-Pacific Bioprocessing Excellence Awards (ABEA) 2022 event.
