Remove Food Remove Pharmaceutical manufacturing Remove Specialization
article thumbnail

LAMP assays to enable rapid and sensitive detection of BCC

European Pharmaceutical Review

According to researchers, a ribB -based colorimetric loop-mediated isothermal amplification (LAMP) assay could become a fast and easy-to-perform detection method for testing non-sterile pharmaceuticals for BCC. Burkholderia species are one of the primary causes of non-sterile pharmaceutical product recalls and accounted for 45.3

article thumbnail

FDA completes inspection of Nexus’ manufacturing facility in US

Pharma Leaders

The Food and Drug Administration (FDA) has successfully inspected Nexus Pharmaceuticalspharmaceutical manufacturing facility located in Pleasant Prairie, Wisconsin, US. The inspection will allow the company to commence commercial operations at the three-storey, 84,000ft² manufacturing facility.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Building CO2-neutral, defossilised supply chains for chemicals

European Pharmaceutical Review

2 However, most of these efforts relating to catalysis, 3 process waste metrics, 4 lifecycle assessments, 5 pharmaceuticals in the environment 6 and the phase out of substances of concern 7 mainly mitigate the consequences of pharmaceutical manufacturing. Defossilization of pharmaceutical manufacturing.

article thumbnail

Cleanroom microbiology: single-temperature incubation for EM

European Pharmaceutical Review

Information can be found in certain US pharmacopeia guide chapters, such as USP <1116>, 1 as well as guidance from the US Food and Drug Administration (FDA) and World Health Organization (WHO) but none of these are regulatory requirements. From this observation, all options are possible.

article thumbnail

Precision Medicine Needs an Overhaul

PM360

Between 2015 and 2021, over a quarter of the drugs approved by the US Food and Drug Administration (FDA) were associated with specific biomarkers. Longevity, wellness, and specialty concierges specialized in precision medicine are a bright spot that can offer new options, and indeed hope for patients and caregivers.