All Method development and validation articles
-
NewsAbbVie’s epcoritamab combination approved as first bispecific therapy for follicular lymphoma in EU
European Commission’s approval brings a chemotherapy-free option to patients and develops AbbVie’s oncology and antibody portfolio.
-
NewsIpsen strengthens rare disease pipeline with €700m acquisition of Memo Therapeutics
Deal involves potential first-in-class BK polyomavirus monoclonal antibody as potential breakthrough therapy in kidney transplantation.
-
ArticleClosing the last mile: the key to fully unlocking healthcare value in Europe
Giancarlo Benelli reflects on why Europe must capitalise on its strong innovative drug discovery infrastructure by shoring up the last mile and attracting clinical trials back to Europe’s healthcare systems.
-
NewsPaulo Fontoura to lead research and development at Sanofi
Taking over from Dr Houman Ashrafian, the 25-year industry veteran will help to advance the firm’s innovation strategy.
-
NewsBiogen acquires immunology start-up RayThera for $1bn
Anti-inflammatory assets in the deal allow Biogen to expand immunology pipeline into new disease areas.
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
NewsNew purification method could enhance protein drug manufacturing
Bioconjugate-functionalised nanoparticles can isolate proteins from a bioreactor fast and inexpensively, MIT researchers have found.