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ADC developers opt to outsource
Most developers of antibody drug conjugates choose to outsource operations to mitigate manufacturing challenges, says report.
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Manufacturing
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Vaccine producers promise equal access in future pandemics
COVID-19 vaccine key players back a new proposal ensuring vaccines for future pandemics are equally distributed to all priority populations.
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Using design of experiments to optimise SEC method conditions for proteins
Size exclusion chromatography (SEC) is routinely used in the pharmaceutical industry to characterise the higher and lower molecular weight species proteins. Here, Gregory Webster, Senior Principal Research Scientist in Analytical Research and Development at AbbVie, explores the challenges, opportunities and optimisations needed to execute design of experiment studies to project…
whitepaper
Application note: Tipping point – what is driving the adoption of rFC for bacterial endotoxin testing?
As industry leaders seek strategies to build supply chain resilience, multi-sourcing is driving the adoption of alternative solutions like rFC.
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Make confident operational decisions by understanding your microflora
Are you leveraging all the information from your QC data? A secure, compliant and powerful data management tool is critical for maintaining a state of control.
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Tackling immune-mediated disease with CAR Tregs
Here, Jason Fontenot, Chief Scientific Officer of Sangamo Therapeutics, discusses with EPR’s Hannah Balfour how the industry is developing chimeric antigen receptor (CAR) T regulatory cells (Tregs) as a potentially paradigm-shifting therapeutic option for conditions driven by the immune system, such as autoimmunity and transplant rejection.
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An Annex 1 and Pharma 4.0 perspective on water quality
Pharma 4.0 is coming and is further driven by the recent update of the EU GMP Annex 1 regarding manufacturing of sterile medical products, setting new regulatory expectations in all manufacturing processes. Here, Isabella Jul-Jørgensen from the University of Denmark focuses on sterile water quality and how the new requirements…
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Full data set for new buffer stock blending system freely available
NIIMBL and BioPhorum reveal open-access design models for a new buffer stock blending system that could help reduce bottlenecks in biomanufacturing plants.
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HPAPI contract manufacturing to value $14.6 billion by 2030
Rising demand for cancer drugs, combined with high in-house manufacturing costs is driving growth in the high-potency API outsourcing market.
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Sanofi to sell Japanese manufacturing plant
Sanofi’s Japan-based manufacturing site near Tokyo will be sold to a European contract development and manufacturing organisation.
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European Pharmaceutical Review Issue 5 2022
In EPR Issue 5, articles explore the role of whole genome sequencing in pharmaceutical microbiology, the formulation of oral taxanes and the potential for tackling immune-mediated disease with CAR T regulatory cells. Plus, coverage of how proposed US pharmaceutical regulation could impact European companies, in-house lentiviral vector manufacturing and much…
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New initiative will calculate carbon footprint of clinical trials
The new methodology will assess the carbon impact of clinical trials and recommend ways to reduce it.
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Are strategic partnerships the winning model for outsourcing?
A University of Cambridge report assessing the preferred relationship type between pharma and contract research organisations (CROs), showed strategic partnerships will continue as the primary collaboration model.
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Funding boost for CPI’s RNA vaccine innovation centre
The UK Government’s Vaccine Taskforce (VTF) has funded CPI’s innovative training academy and manufacturing facility to further the development of novel RNA therapies and vaccines.
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OSD contract manufacturing market valued at $54.7 billion by 2030
Outsourcing the production of oral solids is estimated to be the primary influencer for the contract manufacturing market in the next decade, using lessons learnt from the COVID-19 pandemic.
