Whitepaper: Designing an environmental monitoring solution for GMP
A review of current environmental monitoring practices to ensure that monitoring systems comply with the latest EU GMP Annex 1 2022.
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A review of current environmental monitoring practices to ensure that monitoring systems comply with the latest EU GMP Annex 1 2022.
US Pharmacopeia (USP) and American Type Culture Collection (ATCC) will collaborate to better support the biologics sector in R&D, process development and release of high-quality biologics.
The NanoFlowSizer, unique inline nanoparticle size analyser, is able to monitor nanoparticle suspensions and enable real time monitoring of processes.
Here, Edward C Tidswell, Executive Director Quality Assurance at Merck & Co, Inc., discusses the microbiology challenges for industry, pharmaceutical companies and microbiologists themselves.
Technical Report 90: Contamination Control Strategy Development has been released by the Parenteral Drug Association (PDA).
This interview with Dr Marie Izac, Vaccine Drug Substance Unit Head at Sanofi Pasteur, elaborates on the use of process analytical technology – and specifically mass spectrometry – for continuous respiratory gas analysis.
A paper aiming to identify bacterial isolates on cleanroom operators’ garments, showed these surfaces were a major source of contamination.
EPR Issue 1 includes articles on the future of pharmaceutical microbiology, separation and purification of complex biologics, the latest on nitrosamines and more...
Following on from the first GMP registration of a cannabis API for a UK pharmaceutical facility, EPR spoke with Celadon Pharmaceuticals about how it navigated the complex regulatory landscape.
The planned expansion of Lonza’s bioconjugation facility in Visp, Switzerland has been completed, the company has announced.
A new, high-tech, sustainable biologics manufacturing facility at Genentech’s US Oceanside campus will be operational in early 2025.
The global highly potent active pharmaceutical ingredient (HPAPI) market is expected to reach $34.04 billion in 2026, a report has predicted.
The Cell and Gene Therapy Catapult (CGT Catapult) is set to be involved in the establishment of one of the largest life sciences campuses in Europe.
A two-chamber setup (TCS) for containment investigations could predict the dustiness of HPAPIs in a sealed system at different flow conditions.
The Association of the British Pharmaceutical Industry (ABPI) has urged immediate government action is needed against the planned UK statutory revenue clawback rate rise for branded medicines.