video
On-demand webinar: Avoiding cross contaminations in cleanrooms
Essential points of active air sampling units for use in your high-grade cleanrooms, along with requirements for prevention of cross-contamination.
List view / Grid view
QA/QC
news
EMA recommends updating safety information for HRT and leuprorelin
The EMA has suggested that the safety information be updated for HRT, to reflect a higher risk of breast cancer and recommends new measures for the handling of leuprorelin depot medicines.
news
Spartan’s COVID-19 test recall exposes issues of rapid medical device approval, says report
Following the recall of Spartan Bioscience's COVID-19 test by Health Canada, a report suggests this demonstrates the challenges associated with rapid approval.
whitepaper
Application note: Influence of environmental sample pre-storage
The manufacturing process does not always allow for immediate transfer of samples to the incubator space and may be pre-stored.
video
On-demand webinar: Microbiological control in a pharmaceutical manufacturing environment
This webinar will address the evaluation of microbiological, environmental monitoring data as well as what would be considered significant differences in data.
news
Doubt cast over Avigan (favipiravir) and DAS181 potential to fight COVID-19
A new report has highlighted that the early successes of Avigan (favipiravir) and DAS181 do not guarantee their efficacy against COVID-19.
whitepaper
Whitepaper: Establishing the proper alcohol/water proportion for simulating solvents used in controlled extraction studies
This paper provides scientific guidance as well as a case study on the effect of solvent polarity (ethanol/water proportion) on the levels of extractables.
news
Programme to develop sustainable cold chain delivery for COVID-19 vaccine initiated
Researchers have begun research to find how sustainable cold chain delivery systems for a COVID-19 vaccine can be established in resource-poor countries.
news
ICU Medical recalls one lot of Lactated Ringer’s Injection in US
The US FDA has announced ICU Medical is recalling a lot of Lactated Ringer's Injection due to iron oxide particulates being found by a consumer.
video
On-demand webinar: ICH stability testing and method development
Stability testing is a vital part of product development and is conducted throughout a product’s life cycle.
whitepaper
Whitepaper: Establishing the proper PH range for aqueous simulating solvents used in extractables profiling
This whitepaper considers the chemical properties of commonly encountered acidic and basic extractables and uses these properties to address questions about establishing the proper pH (or proper pH range).
article
Sterile and antiviral packaging: unlocking the potential of business continuity and resilience during COVID-19 pandemic
Amid the disruptions due to COVID-19, companies providing sterile and antiviral packaging solutions look forward to opportunities arising from the concern over viral exposure itself. Regulatory compliance will play a significant role in the rapidly shifting risk terrain.
news
EMA recommends eight drugs for approval from April meeting
The EMA's human medicines committee has adopted a positive opinion for eight medicines, recommending their marketing authorisation.
news
New standards to help remove foreign particles in bioprocessing
ASTM International says its new standard for single use system manufacturing processes will help to prevent the contamination of biopharmaceuticals with foreign particles.
news
Utilising CRISPR could reduce contamination in recombinant-protein drugs
Researchers have used CRISPR-Cas to edit the genes of contaminating proteins in mammalian cells used to produce recombinant-protein drugs, which could reduce costs and strengthen quality.
