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How an inline vial management device is able to reject, retrieve for sampling, or reintroduce vials automatically during the loading/unloading process into pharmaceutical freeze-dryers.
Overview on how ionBench products can help LC/MS users with dedicated furniture for their instrumentation
A treatment for amyloidosis has been pulled from clinical trials after failing to reach endpoints.
The National Institute for Health and Care Excellence is recommending MSD’s Prevymis (letermovir) within the NHS.
Walmart has joined a consortium that’s attempting to build a blockchain for tracking pharmaceutical supply chains.
Heritage has recalled two of its injectable treatments after microbial growths were found.
The US Food and Drug Administration (FDA) has approved Piqray (alpelisib) tablets to treat patients with breast cancer.
FDA sends warning to Petra Hygienic Systems Int LTD after they find violations of current good manufacturing practices (cGMPs).
As a single-source supplier of equipment solutions for the primary packaging of injectable drugs, Steriline develops, manufactures and supplies a comprehensive range of solutions, including both mechanical and robotic applications for the aseptic processing.
As a single-source supplier of equipment solutions for the primary packaging of injectable drugs, Steriline develops, manufactures and supplies a comprehensive range of solutions, including both mechanical and robotic applications for the aseptic processing.
As the pioneers of the Limulus amebocyte lysate (LAL) testing methodology, Associates of Cape Cod, Inc. (ACC), specialises in bacterial endotoxin and (1→3)-ß-D-glucan detection, using FDA-licensed chromogenic, turbidimetric and gel-clot reagent technologies.
As a single-source supplier of equipment solutions for the primary packaging of injectable drugs, Steriline develops, manufactures and supplies a comprehensive range of solutions, including both mechanical and robotic applications for the aseptic processing.
This article expresses the opinions of a pharmaceutical microbiologist on the proposed revisions to the EU Good Manufacturing Practice Annex 1 in terms of current industry practice and future innovation in sterile product manufacturing.
An important step in the research and development of biopharmaceuticals is to identify molecules with favourable physical and chemical stability profiles. Yongchao Su, Wei Xu and Bruce Yu discuss how solution, solid-state and benchtop nuclear magnetic resonance (NMR) methods can provide advanced biophysical characterisations of biological products.
Appropriate standards for impurity tests are an important part of analytical testing. In this paper, Kevin Williams outlines various requirements of standards for endotoxin, as stated by United States Pharmacopeia (USP), and elaborates on the definition of endotoxin as distinct from other cellular constituents.
