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In Depth Focus QA/QC Microbiology/RMM 2023
This in-depth focus explores collaborative efforts to accelerate validation and adoption of rapid microbial methods across the pharmaceutical industry and the power of rapid methods for fungal ID.
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Reflecting on five years of quality control for nitrosamine impurities
Since the US Food and Drug Administration (FDA)’s report on a series of nitrosamine-related impurity drug recalls in 2018, pharma has made great strides in its ability to detect and control for these impurities. Dr Mrunal Jaywant, Vice President of R&D at USP India proposed a collaborative, cross-community approach between…
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HPLC market projected to value $8 million by 2030
Research has shown that the global high-performance liquid chromatography (HPLC) market is being driven by the need for precise analytical tools in drug development and quality control (QC).
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European Pharmaceutical Review Issue 3 2023
EPR Issue 3 includes articles the role of titanium dioxide in pharmaceutical formulations, bioprocessing innovations for cell and gene therapies, manufacturing of radiotheranostics and more …
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Reducing bioburden testing and sterility testing volumes for gene therapies
A reduced sampling plan was recommended in a Biophorum report for reducing required bioburden and sterility testing volumes for gene therapy batch yield.
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Video: An introduction to Protak Scientific and Enzyme Indicators for advanced, gaseous bio-decontamination validation
The advanced rapid validation tool for measuring hydrogen peroxide bio-decontamination performance that’s transforming the validation process in pharmaceutical manufacturing and other applications including healthcare and research.
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Case study: Eliminating contamination with whole genome sequencing
Read this case study to learn how a pharmaceutical company used Accugenix Whole Genome Sequencing for bacterial and fungal ID.
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Why is microbiological testing in medical device manufacturing important?
Careful planning during manufacture means accurate microbiology testing methods can be developed, ensuring the safety and efficacy of medical devices, a paper reports.
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6.1 percent CAGR expected for pharmaceutical sterility testing market
The rising importance of quality and sterility is expected to drive the pharmaceutical sterility testing market in the next decade, a report says.
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Scientific journal: Reduce CNS drug development timelines by up to 40%
CNS drug development is complex, and partnering with an integrated CRO/CDMO can reduce your timelines by up to 40%. Learn more in The Altascientist.
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Novel nanofiltration method for microbial biosurfactant downstream processing
A paper has reported an innovative downstream method using nanofiltration for microbial biosurfactant production offers superior purity.
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EDQM publishes annual report
Included in EDQM’s annual report were reflections on the 11th Edition conference, which highlighted key topics such as the potential of nanomedicines and Big Data.
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Study identifies key contamination source during ATMP manufacture
Researchers say they are the first to demonstrate contamination of over 40 percent of lipoaspirate samples for adipose tissue-derived stem cell (ADSC)-based advanced therapy medicinal product (ATMP) manufacture.
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Analysis reports nitrosamine prevalence in small molecule drugs
Data from a paper on small molecule drugs has indicated nitrosamines in pharmaceuticals is likely more prevalent than originally expected.
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Novel PAT system could enable adaptive process control
A paper has demonstrated a novel refractometry-based process analytical technology (PAT) system has potential for enabling adaptive process control in CGT manufacturing.
