news
Importance of sublimation tests when freeze-drying HPAPIs shown in study
Researchers have shown that sublimation tests should be conducted if new components are added to the freeze-drying process of HPAPIs.
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news
Alter Pharma Group adopts Movilitas.Cloud to ensure safer goods and EU FMD compliance
Movilitas has announced that Alter Pharma Group has adopted its Movilitas.Cloud software to meet requirements throughout the product path and changes in packaging under the EU FMD regulation.
article
How will clinical trials change in light of COVID-19?
Barbara Lopez Kunz from the Drug Information Association (DIA) discusses how COVID-19 has impacted clinical trials.
news
Clinical trial for AstraZeneca Oxford COVID-19 vaccine candidate to resume
After the clinical trial for AZD1222 was halted last week, the studies for AstraZeneca's COVID-19 vaccine candidate will now resume.
article
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.
news
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.
article
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…
article
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.
article
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.
article
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.
