news
Novel immunotherapy approved for melanoma
The first non-CAR-T adoptive cell therapy to reach the market has been approved by the US Food and Drug Administration (FDA).
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Manufacturing
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SGS joins forces with Agilex Biolabs
SGS, the world’s leading testing, inspection and certification company, is excited to announce a partnership with Agilex Biolabs, Australia’s largest and most technologically advanced regulated bioanalytical laboratory. This collaboration marks a significant step in strengthening SGS’s global footprint in the bioanalysis services sector.
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Overcoming challenges of continuous antibody manufacture
During monoclonal antibody (mAb) manufacture, continuous flowsheets could offer ~20 percent–40 percent cost of goods (COG) saving over the batch process, for instance, during low commercial demand, a paper suggests.
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Nelson Labs facility expansion to benefit parenteral and ophthalmic drug product manufacturers
The new Pharmaceutical Center of Excellence from Nelson Labs offers state-of-the-art chemistry manufacturing and controls (CMC) analytical testing support.
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Navigating the unique CMC challenges of oral anaerobic live biotherapeutics
Here, Chief Technical Officer, Mike Frodsham and Ryan Wilson, Head of Microbiome Services at SGS Quay Pharma, explore the chemistry, manufacturing, and control (CMC) challenges of developing drug products containing live anaerobic bacterial strains, used for treatments such as microbiome therapeutics.
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Biologics – manufacturing trends in a modern facility
Liam Dunne, MSD Biotech Site Lead, speaks to Danielle Barron about how the Dublin site is leveraging the latest technologies, from real-time process monitoring to the latest upstream techniques, helping to ensure reliability and quality of global supply.
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BioNTech agrees collaboration to accelerate autologous CAR-T therapies
The collaboration between BioNTech SE and Autolus Therapeutics utilises manufacturing and commercial infrastructure, supporting a shared goal of advancing autologous CAR-T programmes towards potential market authorisation.
webinar
Are outdated microbial identification methods risking your product safety and operational efficiency?
9 February 2024 | By Charles River Laboratories
Watch this webinar to unravel the complexities of microbial identification technologies and their pivotal role in fortifying contamination control strategies within the pharmaceutical industry.
whitepaper
Whitepaper: Unique Particle Sizes via Spiral Jet Mills
Discover how combining a spiral jet mill with an in-line classifier optimizes particle size distribution in pharmaceuticals, enhancing drug efficacy.
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AstraZeneca to boost cell therapy operations with $300m manufacturing investment
Investment in the US manufacturing facility will accelerate AstraZeneca’s ambition to make next-generation cell therapy a reality, the company asserts.
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How will automation shape deviation management in continuous bioprocessing?
A paper has proposed how advanced manufacturing process technologies such as integrated continuous bioprocesses (ICB) could impact the future of deviation detection and control.
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Novo Nordisk $11b acquisition to support manufacturing capacity
As part of its acquisition of Catalent, Novo Holdings plans to sell three Catalent fill-finish sites, supporting the growth of the European and US manufacturing capacity.
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Construction of major radioligand therapy manufacturing site begins
The new site will be Europe's first industrial-scale pharmaceutical facility dedicated to the production of lead-212 based radioligand therapies.
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WuXi Biologics achieves large-scale manufacturing milestone
The environmentally-sustainable inaugural manufacturing run at WuXi Biologics’ GMP-certified facility in Ireland combined four 4,000-litre single-use bioreactors.
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Eli Lilly EVP of Global Quality to retire
Following her leading contribution in key manufacturing and quality projects in Ireland and the US, Eli Lilly and Company’s Executive Vice President (EVP) of Global Quality is set to retire after nearly 35 years of service.
