All Method development and validation articles
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NewsBiogen acquires immunology start-up RayThera for $1bn
Anti-inflammatory assets in the deal allow Biogen to expand immunology pipeline into new disease areas.
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NewsCorrectSequence’s base-editing therapy shows preliminary success in sickle cell disease
Achievement of study’s primary efficacy endpoint positions therapy as potentially safer and more effective approach to CRISPR-based gene-editing therapies.
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NewsMHRA proposes modernisation of gene therapy products classification
UK medicines agency calls for a more technologically neutral approach to the current legal definitions of gene therapy medicinal products.
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WebinarThe either-or trap: consequences of enhanced mechanical calibration vs fully qualifying your dissolution equipment
USP expert discusses how to confidently qualify your dissolution equipment and avoid costly testing errors.
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NewsNovel PAT tool could improve pharmaceutical QC
The at-line PAT method utilised machine-vision and was able to predict API content of tablets containing amlodipine and valsartan with low relative errors.
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ArticleValidation of analytical procedures – ICH Q2(R2)
The recently updated ICH Q2(R2) guidance marks a significant milestone in analytical procedure validation. Dave Elder explains why.
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NewsHow to approach die plate adhesion during tableting
A study by IMA and Labomar has illustrated a gentle but effective approach for achieving defect-free tablets and an adhesion-free die plate.
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NewsMicrofluidic device detects bacteria concentration from small sample volumes
A novel ultrasonic nanosieve enabled concentration of bacteria into a 1µL highly concentrated solution suitable for plate counting and PCR, according to research.
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NewsMIT unlocks real-time powder particle size distribution monitoring
Massachusetts Institute of Technology researchers have developed an algorithm that extracts powder particle size distribution from laser speckle in real-time.
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NewsNew purification method could enhance protein drug manufacturing
Bioconjugate-functionalised nanoparticles can isolate proteins from a bioreactor fast and inexpensively, MIT researchers have found.