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Sterile medical packaging: the need of the hour amid the COVID-19 pandemic
Reeti Banerjee explains why the use of sterile packaging for medicines will see a growth in the near future, mostly due to the COVID-19 pandemic.
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QA/QC
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Dexamethasone Taw application to treat COVID-19 to be evaluated by EMA
Dexamethasone Taw will be examined by the EMA on an accelerated assessment timetable, to assess whether it should be given to patients with COVID-19.
news
EMA safety committee recommends withdrawal of ulipristal acetate marketing authorisation
The EMA's PRAC has recommended the revocation of the marketing authorisation for ulipristal acetate, after a review confirmed liver injury caused by the medicine.
news
Global sterility indicator market to be worth over $1 billion by 2026
According to new research, the global sterility indicator market is set to grow at a CAGR of 10.8 percent over the forecast period.
news
Further clinical trials testing Kevzara as COVID-19 therapy to be halted
After Kevzara (sarilumab) did not meet its primary or secondary endpoints in a Phase III trial, Sanofi and Regeneron have said they do not expect to conduct further studies on the drug against COVID-19.
whitepaper
Whitepaper: Characterising insulin as a biopharmaceutical using Analytical Ultracentrifugation
AUC was used to probe the effect of insulin concentration and the zinc chelating agent EDTA on monomer, dimer, and hexamer formation of USP Human Insulin Standard.
video
On-demand webinar: An update on remote and virtual auditing
NSF expert Dave Waddington discusses the challenges and benefits associated with remote and virtual GMP audits.
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Exploring and deploying blockchain solutions in the life sciences and healthcare sectors
Blockchain is perhaps best known as the technology on which Bitcoin and other cryptocurrencies are built. Notwithstanding that adoption in the life sciences and healthcare sectors is still in its relative infancy, companies and other organisations in these sectors are increasingly exploring and deploying blockchain solutions. Here, legal experts James…
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Improving quality in investigator‑led clinical trials
Laura Trotta explains why risk-based quality management is the best strategy to ensure data integrity of information from investigator-led clinical trials.
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NDMA: a recall trigger for the drug development industry
Product recalls due to contamination issues can be extremely costly for companies, in addition to the associated health implications. In this article, Marc Baiget Francesch explores the potential risks associated with N-nitrosodimethylamine (NDMA) contamination, why is it such a frequent contaminant and how to detect and eliminate the risks.
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Release of sterile medicinal products – looking at the focal points
There are numerous risks and regulatory requirements that must be considered to ensure appropriate contamination control of sterile medicinal products. Tim Sandle discusses the complexities of sterility assurance and provides guidance for manufacturers to ensure that appropriate risk management processes are in place.
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Expert view: Our air samplers are designed to perfectly match customer needs
A discussion between experts Roger Haas, Head of Environmental Monitoring Franchise at Merck KGaA, Darmstadt, Germany, and Ronny Zingre, CEO of MBV AG.
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Expert view: Realising real-time TOC testing and Pharma 4.0 improvements in pharmaceutical grade water systems
This expert view from SUEZ discusses how total organic carbon (TOC) and conductivity monitoring are crucial aspects of purified water system quality and control.
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Bioprocessing & Bioproduction In-Depth Focus 2020
In this in-depth focus are articles on what manufacturing challenges must be overcome for regenerative medicine to reach its potential and how automation and digitalisation ensure efficient bioprocessing.
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QA/QC & Analytical Techniques In-Depth Focus 2020
Included in this in-depth focus is a discussion on how to detect and eliminate NDMA impurities in medicines and an article exploring the complexities of sterility assurance, providing manufacturers with guidance.
