Regulators recommend remote inspections for use post-pandemic
A review of remote regulatory inspections has recommended that they be used in conjunction with on-site visits to enable GxP oversight post-pandemic.
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A review of remote regulatory inspections has recommended that they be used in conjunction with on-site visits to enable GxP oversight post-pandemic.
The global generics drug market is anticipated to grow to $574.63 billion by 2030, owing to the increasing application of robotic process automation, branded medicine patent expiries and the rising prevalence of chronic diseases.
Long before the advent of Coronavirus, next-generation therapies were making headlines, but the successful development of COVID-19 vaccines, including mRNA vaccines, has now shone a spotlight on next-generation therapies. This offers a boost to the long-term growth projections for the advanced therapy medicinal products (ATMPs) sector. But although ATMPs hold…
A new microfluidics tool, the Dynamic Sampling Platform, could improve biomanufacturing of cell therapies by reducing the cost of analysing bioreactor contents.
Creating new biologic drugs from early research is a complex process, but certain development methodologies and practices are proving to reach clinical and commercial goals faster. In this article, Seahee Kim from Samsung Biologics provides insight into how contract development and manufacturing organisations (CDMOs) are applying new and effective methodologies…
Why are precision medicines important? What challenges face their development and manufacture? Where could they be in 10 years? Discover all this and more in this podcast with Janssen!
Looking at patent and publication data, researchers show the applications and potential of cell-free protein synthesis systems are growing.
Growth in the global transfection technologies market will be driven by emerging methods and the increasing prevalence of chronic diseases over the next five years.
Researchers have developed a novel platform technology, iVAX, that could enable the decentralised bioproduction of conjugate vaccines and enhance vaccination rates in developing nations.
Research comparing intensified bioprocesses to fed-batch shows high cell density perfusion significantly advances productivity while maintaining quality and costs.
Research shows using the greatest common divisor (GCD) to define batches in continuous biomanufacturing enhances process control and raw material traceability.
Join Rey Mali and Félix Montero-Julian as they discuss the challenges facing the manufacture and QC of advanced therapy medicinal products (ATMPs) and potential solutions.
The Gates Biomanufacturing Facility announced a strategic agreement with Nkarta to manufacture Nkarta's investigational cell therapy NKX101.
Rich Quelch, Global Head of Marketing at DiD,1 explores how packaging can help pharma to cut costs, uphold high quality standards and improve health outcomes.
Researchers review how miniaturised process analytical technologies (PAT), microfluidic affinity assays and microchip capillary electrophoresis, enhance bioprocess monitoring and control.