Tim Sandle explores the main factors that influence particle accumulation in pharmaceutical cleanrooms, advising how best to control risks and minimise operator contamination.
The German Pharmaceutical Industry Association has launched the ERA Pooling Initiative, a collaborative project enabling marketing authorisation holders to share environmental data, reduce duplicative testing and meet tightening regulatory requirements.
A hybrid model built into commercial software and running a self-driving bioreactor has found that unmeasured cellular waste, not the usual metabolites, throttles perfusion yields.
The definitive guide to transitioning from manual, offline batch testing to automated, continuous biomanufacturing.
First combination regimen to demonstrate significant reduction in recurrence risk in completely resected stage IIB-IV melanoma compared to Keytruda alone as adjuvant treatment.
Opening of the two advanced manufacturing facility expansions strengthens the CDMO’s capabilities in large-scale commercial small molecule API production and HPAPI manufacture.
The regulator’s new position paper provides developers with a defined regulatory route to licence microbiome-based medicinal products in the UK.
Discussions from the Animal Testing Replacement for Vaccines: A One Health View – Global Outlook and Future Strategy conference have been summarised in a recent report, highlighting progress towards non-animal vaccine testing alongside the regulatory and operational challenges that remain.
Join USP to explore the latest approaches to organic impurity analysis and scientific solutions to support pharmaceutical quality, including regulatory expectations and practical applications of the USP Reference Standards.
Join this webinar to discover how modern QA/QC laboratories are embracing digital transformation to enhance compliance, workflows and data integrity to build a more connected, future-ready pharmaceutical quality ecosystem.
Join this webinar to discover how UV-Vis spectroscopy and gas chromatography support API monitoring, testing and analysis.
Manual sampling cycles leave bioreactor control decisions hours behind culture dynamics. Process Raman spectroscopy offers continuous, real-time measurement of critical parameters, enabling true closed-loop control in perfusion and continuous bioprocessing applications where measurement lag directly impacts yield and product quality.
The biopharmaceutical industry has embraced Pharma 4.0 concepts, but the measurement infrastructure required to realise autonomous facilities and continuous bioprocessing remains underdeveloped. Process Raman spectroscopy offers continuous, non-destructive monitoring at frequencies aligned with cell culture dynamics, bridging the gap between control system capabilities and available data.