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European Pharmaceutical Review Issue 4 2024
European Pharmaceutical Review Issue 4 includes articles on regulation, bioproduction, environmental monitoring, packaging and drug delivery.
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Bioprocessing
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Improving upstream fermentation with end-to-end automation
The automated system “significantly improved process control”, resulting in greater productivity of a small-molecule drug substance.
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Enhancing cell proliferation in bioproduction with non-invasive technology
The method has potential in both biomanufacturing and production of autologous cell therapies, the research suggests.
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Downstream process shows potential for oncolytic virus purification
The paper presents an “efficient and scalable GMP-compliant process” for purifying a fusogenic oncolytic virus (rVSV-NDV).
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Achieving VLP continuous production with digital twins
Utilising a digital twin for an advanced process control strategy facilitates additional productivity gains of 20 percent at 99.9 percent reliability, the authors shared.
whitepaper
Whitepaper: USP <645> Water Conductivity Regulations
31 July 2024 | By
This whitepaper looks at benefits of measuring conductivity on-line, and calibration and temperature compensation criteria for USP compliance.
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Application note: Validating recombinant cascade reagents in 3 simple steps
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).
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Combining biofermentation and chemical synthesis to manufacture complex molecules in pharmaceutical applications
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.
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European Pharmaceutical Review Issue 3 2024
European Pharmaceutical Review Issue 3 includes articles on microbiology, downstream bioprocessing and drug development. Register your details now to download this exclusive content.
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One HEK of a viral vector to develop
Viral vector manufacturing presents many challenges related to HEK cell line development, fluid transfer and product viability in the cold chain.
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Optimising iPS cell-based platelet manufacturing scale up
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.
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Webinar: Overcoming contamination risks during biologicals production: Mycoplasma & virus testing
Listen to the discussion on contamination risks in biomanufacturing, featuring mycoplasma and virus testing per European Pharmacopoeia and USP standard
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Case study: Data-driven water system maintenance
This case study looks at how an online microbial analyzer provides real-time bioburden monitoring for rapid response to adverse water system events.
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WuXi facility boosts bioprocessing capacity with new bioreactors
The new installation increases capacity at WuXi Biologics’ Hangzhou manufacturing facility from 8,000L to 23,000L.
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Case Study: Franz Ziel’s utilisation of Enzyme Indicators using Fractional Kill Time method
3 June 2024 | By
An EJPPS published study on Enzymatic Indicators in Vaporized Hydrogen Peroxide Decontamination Cycles: Application-related Research focusing on Fractional Kill Time (FKT) and Reverse Fractional Kill Time (RFKT) Studies
