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US Government investigation report suggests Emergent Biosolutions destroyed almost 400 million doses of COVID-19 vaccine and worked to conceal quality issues from the FDA.
Learn the benefits of collaboration between the pharmaceutical scientists and clinical supply services teams.
12 May 2022 | By Bruker
In this webinar, experts will discuss state of the art technology to characterise polysaccharide vaccines and relative implementation in biopharma development and manufacturing.
Learn about 21CFR.11 and Annex 11 requirements and how you can implement a rapid bioburden analyser designed to meet compliant operation needs.
Best practices for leveraging the resources of sourcing vendors are vital to anticipating and avoiding clinical supply delays.
Phase III trial shows fenfluramine as an adjunct to existing anti-epileptic treatment is effective in reducing the frequency of drop seizures from Lennox-Gastaut Syndrome (LGS).
Here, EPR’s Hannah Balfour discusses the latest reports on pharmaceutical counterfeiting and falsification, exploring global and European crime rates, as well as recent counterfeiting incidents reported by Big Pharma.
Most industries face mould contamination issues, including medical products, hospitals, cosmetics, paint, among others. Learn more about mould and what you can do to combat it.
With comment from Diane Paskiet, chair of the Product Quality Research Institute (PQRI) L&E Working Group, EPR’s Hannah Balfour outlines three key exposure-based safety thresholds and explores how the new extractables and leachables (E&Ls) strategy for parenteral drug products was established.
At its latest meeting, EMA’s human medicines committee (CHMP) recommended the approval of four medicines, seven extensions of therapeutic indication and laid out recommendations for diabetes treatment outside of the EU.
How to select a CDMO partner for the development and commercial manufacture, packaging and launch of products containing highly potent APIs.
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…
The new clinical trial guidance asks sponsors to submit a Race and Ethnicity Diversity Plan outlining how they plan to enrol participants from underrepresented populations.
The examples of common applications in the pharmaceutical industry for titration, UV/VIS spectroscopy and physical values are presented in details.
Novartis’ Vijoice® (alpelisib) is the first and only treatment approved for the treatment of the rare spectrum of conditions associated with PROS in certain patients.
