Chromatography analysis for nitrosamine quantitation in pharmaceutical manufacturing water
The paper describes an innovative ion chromatography-based analytical method for quantifying nitrite quantities in purified and potable water.
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The paper describes an innovative ion chromatography-based analytical method for quantifying nitrite quantities in purified and potable water.
Single-temperature incubation has been discussed for a long time in the pharmaceutical industry but only a few sites have implemented this system. Here, Guillaume Pinon, Head of the Microbiology Lab at Servier, discusses the use of single-temperature incubation in an aseptic production facility, outlining the regulatory considerations, strategic approach, challenges…
The Association of the British Pharmaceutical Industry (ABPI) and Drug Research Safety Unit (DRSU) assert the importance of partnership and collaboration to support the pharmaceutical industry under the new UK government.
The investigators hope that their new approach could lead to large-scale manufacturing of the CAR T cells for blood cancer patients.
Endotoxin testing continues to evolve alongside the industry’s need for more sustainable methods that reduce ecological impact. Nicola Reid, Associate Director of Endotoxin Products, Charles River Labs, reflects on these developments which are driven by the 3Rs (replacement, reduction and refinement).
Continuous chemical manufacturing technology has been in use for more than 100 years producing high-volume commodity chemicals. However, it was not until the early 2000s that the technology caught the attention of the pharmaceutical industry in a significant way.
It is well known that nature, being a rich source of bioactive natural products, offers up a massive number of candidate drugs for the pharmaceutical industry. David Blanco, Industrial BD and CDMO Director at Suanfarma CDMO, reveals why biofermentation benefits from additional processing to produce a viable drug candidate.
In this Guide to Data integrity articles explore the role of data integrity in CCS, AI and ML as well as biopharma manufacturing.
European Pharmaceutical Review Issue 3 includes articles on microbiology, downstream bioprocessing and drug development. Register your details now to download this exclusive content.
Novo Nordisk plans to allocate $6.8 billion towards production to expand its overall US manufacturing capacity.
Viral vector manufacturing presents many challenges related to HEK cell line development, fluid transfer and product viability in the cold chain.
Large-scale platelet manufacturing must consider turbulent energy and shear stress as well as the undesired turbulent flow space within a bioreactor, the paper concluded.
Research has highlighted the potential of using robotics for isolator filling line interventions, enabling gloveless executions by operators.
Currently, the Latina site exports 97 percent of the medicine it produces, according to Johnson & Johnson Innovative Medicine.
The new, potentially multi-billion-dollar deal will help bring a next-generation therapy to patients with inflammatory bowel disease (IBD), an autoimmune condition.