news
Amyloidosis treatment discontinued from clinical trials
A treatment for amyloidosis has been pulled from clinical trials after failing to reach endpoints.
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QA/QC
news
NICE recommends Prevymis on the NHS after re-evaluation
The National Institute for Health and Care Excellence is recommending MSD’s Prevymis (letermovir) within the NHS.
news
New partnership established to track drugs using blockchain
Walmart has joined a consortium that’s attempting to build a blockchain for tracking pharmaceutical supply chains.
news
Heritage announces product recall after sterility test failure
Heritage has recalled two of its injectable treatments after microbial growths were found.
news
First PI3K inhibitor for breast cancer approved by FDA
The US Food and Drug Administration (FDA) has approved Piqray (alpelisib) tablets to treat patients with breast cancer.
news
FDA sends warning letter to Canadian OTC manufacturer
FDA sends warning to Petra Hygienic Systems Int LTD after they find violations of current good manufacturing practices (cGMPs).
product
Steriline products and solutions: Intelligent compounding systems
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.
product
Steriline products and solutions: Robotic applications
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.
article
Comprehensive consultation, validation, training and support
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.
product
Steriline products and solutions: Isolators
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.
article
Concerns around Annex 1
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.
article
Emerging NMR techniques as advanced tools for characterising biological parenteral products
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.
article
Endotoxin definition and standardisation
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.
whitepaper
Whitepaper: Digital transformation in QA/QC labs
With international regulatory agencies calling for pharma companies to properly manage data integrity issues to ensure GMP compliance, Abbott Informatics demonstrates how their STARLIMS solutions can provide support for numerous systems.
webinar
The role of an integrated LIMS solution on supporting data integrity in current cGMP environments
14 May 2019 | By Abbott Informatics
Understand the role of data integrity in current good manufacturing practice for drugs as required in 21 CFR parts 210, 211, and 212.
