Researchers use the Earth’s biodiversity for pharmaceuticals, but this is under threat due to climate change and habitat destruction. The Nagoya Protocol aims to conserve these resources in a sustainable way.
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Two lots of Kogenate® FS vials actually contain the FVIII hemophilia A treatment, Jivi®.
The FDA has handed a CRL to Biohaven for its ALS treatment awaiting approval due to concerns regarding the medication’s API.
The FDA has released draft guidance for using the Inactive Ingredients Database to aid drug developers.
Metallic contamination in drug products, referred to as elemental impurities, may arise from several sources. They may be added intentionally in synthesis, or may be present as contaminants, (e.g., through interactions with processing equipment or by being present in components of the drug product) and are consequently detectable in the…
Nelson Labs has a long history of partnering with pharmaceutical and biopharmaceutical companies. We perform a variety of testing to support your internal quality processes including: sterility (USP 71) testing in a cleanroom for isolator environment, particulates testing (USP 787, 788) using a variety of methods, bacterial endotoxin, filter validations,…
Emerging recombinant Factor C (rFC) methods have many advantages to offer pharmaceutical quality control, including improved specificity, robustness, efficiency and alignment with 3R principles. First, global manufacturers have validated rFC and pharmacopoeias worldwide are on the move. Here, Karolina Heed provides an industry and regulatory update.
In the present study, the performance of PROSOLV® EASYtab SP was tested in four DC formulations with different model APIs. Each of the selected APIs presented a particular challenge in terms of producing tablets with suitable hardness, weight, uniformity, content uniformity and/or reliable dissolution profiles.
A brief overview of how SWAN Analytical Instruments helps to ensure water quality with analysers to measure trace ozone and total organic carbon (TOC).
Seventy-two percent of chemistry professionals said that a no-deal Brexit would be “very negative” for the sector, survey finds...