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Guide to Testing 2024
LoD requirements of qualitative microbiological methods for short shelf-life products In this article, Edwin van den Heuvel from Eindhoven University of Technology and MSD’s Pieta Boon investigate the...
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Bioprocessing / Bioproduction In-Depth Focus 2024
Unlocking the potential of biologics production: a comprehensive exploration Different types of biologics require different sized bioreactors and different manufacturing approaches, as Sridevi...
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Under the microscope: Using recombinant reagents for BET
Can you provide an overview of the developments around recombinant reagents for bacterial endotoxin testing (BET)? Advancements in recombinant technologies have changed the landscape of BET, offering...
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Application of NGS to enhance the molecular monitoring of CML patients
ICON has developed a novel RNA-based Next Generation Sequencing (NGS) assay that supports more accurate monitoring of chronic myeloid leukemia patients. Here we discuss its benefits over standard NGS...
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Advancing pharmaceutical technology: trends and innovations at ACHEMA 2024
The pharmaceutical industry, a driving force for global innovation and health, is undergoing a transformative period marked by technological advancements and emerging challenges. In this dynamic...
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Advancements and knowledge gaps in ICH Q2(R2)
The landscape of scientific and technological advancements has evolved significantly since the finalisation of the first version of ICH Q2 in the 1990s. Particularly notable is the progress in advanced...
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ICH Q14 – latest guideline on analytical procedure development
Last issue, we looked at the revisions to the ICH Q2(R2) – Validation of analytical procedures1,2 guidance. Now, we will look at the newly issued guidance on analytical procedure development (ICH...
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Fresh or frozen? Navigating the cryopreservation dilemma for CGT
Although fuelled by unprecedented impact on patients, scaling up cell and gene therapies (CGTs) for commercial accessibility has proven to be an enormous challenge. This nascent industry still has much...
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Delivering long-acting oral treatments
How has the drug delivery landscape evolved in recent years? Over the last few years, we have witnessed increasingly impressive innovations in the drug delivery landscape that have advanced our ability...
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SFC-MS: advancements and applications in pharmaceutical quality control
Pharmaceutical quality control (QC) is an essential aspect of the pharmaceutical industry, ensuring that medicinal products meet the desired quality standards and comply with regulatory requirements....
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