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Poland-based Polpharma API relies on Waters analytical instrumentation for impurities method development and testing to meet the ever-evolving regulatory guidance around N-nitrosamines (nitrosamines) control in active pharmaceutical ingredients (API).
The new identity of Suanfarma’s industrial brands signifies integration of its manufacturing sites as part of Suanfarma CDMO.
Included in the revised ISO 10993-17 guideline are requirements for toxicological risk assessment of medical device constituents, such as extractables and leachables (E&L).
Lek Pharmaceuticals, part of Sandoz, has started building a $400 million biologics manufacturing centre in Slovenia.
In this interview, Anil Kane, Executive Director and Global Head of Technical & Scientific Affairs, Pharma Services, at Thermo Fisher Scientific discusses innovations in oral delivery of biologics, the rising popularity of prefilled syringes as well as global pharma trends in regulation and manufacturing.
Alongside its new biosimilar facility, Sandoz’s new penicillin production process will help secure European-based antibiotic supply.
Camfil´s 10 tips whitepaper will help you choosing the right cartridge dust collection equipment for your tablet press applications.
Effective filtration combined with containment solutions ensure that dust doesn´t escape during normal operation as well as during routine maintenance.
A study by IMA and Labomar has illustrated a gentle but effective approach for achieving defect-free tablets and an adhesion-free die plate.
NMR relaxometry is a promising technique for identifying pharmaceutical raw materials without the need for laboratory testing. Gregory Webster, Senior Principal Research Scientist at AbbVie, considers the use of NMR relaxometry for identity confirmation of monoclonal antibodies.
CPHI, the global pharmaceutical exhibition will take place in Milan, Italy from 8-10 October 2024.
Continuous-flow manufacturing of the antibiotic cefazolin can cover mass production within compact manufacturing facilities and contribute to a stable drug supply, researchers have reported.
A paper has stated that applying the quality by design (QbD) principle during development of bilayer tablets will “help improve product design while also enhancing the quality, safety, and efficacy of drug products”.
Anticipating similar demand of antibiotic use in prior winter seasons, the European Medicines Agency (EMA) has proposed key actions to mitigate supply chain issues.
There continues to be a correlation between low site inspection scores and potential drug recalls, states the US Office of Pharmaceutical Quality (OPQ) 2022 annual report.
