Should environmental isolates be used in pharmaceutical microbiology?
Are environmental isolates truly beneficial in qualifying microbiological methods? Here EPR summarises Tim Sandle’s recent paper on the debate.
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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…
Disulphide bonds between cysteines play a critical role in the stability and activity of therapeutic antibodies. Here, Dr Ioannis Papayannopoulos, Principal Scientist at Dragonfly Therapeutics, describes the characterisation of the oxidation state of cysteines and formed disulphides in therapeutic antibody drugs.
Novel and advanced therapies have come on in leaps and bounds over the past decade. Some cell and gene therapies have already reached the approvals stage, while others have now entered the later development stages. As a result, manufacturing process consistency, GMP standards and more must now meet more formal…
Find out how SGS’s high-quality analytical testing solutions could benefit all phases of your drug development programmes, from discovery through commercialisation.
How to select a CDMO partner for the development and commercial manufacture, packaging and launch of products containing highly potent APIs.
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.
In this in-depth focus, articles illustrate how mass spectrometry‑based wastewater analysis can estimate illicit drug usage and explore the applications of mass spectrometry in characterising therapeutic antibodies.
Features in this issue discuss how bioprocessing must adapt to meet the needs of autologous cell therapies, the role of mass spectrometry in enhancing antibody consistency and the economic benefits of embracing continuous manufacturing. Also in this journal, articles exploring the development of precision medicine for chronic diseases, why acoustic…
Water content determination of Ibuprofen tablets with an automated Karl Fischer titrator coupling with gas phase extraction.
A lot of Moderna’s Spikevax® vaccine is being recalled due to particulates, just six months after previous contamination concerns were supposedly solved.
In this article, pharmaceutical microbiologist and contamination control expert Tim Sandle presents three microbial contamination investigation case studies, highlighting the key lessons for pharmaceutical microbiologists to take away and the underlying importance of identifying the root cause of microbial data deviations.
Researchers used computational fluid dynamics (CFD) simulations to assess their cleanroom airflow and suggest improvements that would reduce contamination levels.