FDA releases draft guidance for cell and gene therapy industry
The US FDA has published two draft guidance documents, one on gene therapy products and the other CAR T-cell therapies, for developers and manufacturers.
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The US FDA has published two draft guidance documents, one on gene therapy products and the other CAR T-cell therapies, for developers and manufacturers.
In a new paper, Lumen Bioscience detailed how spirulina can be genetically engineered for to rapidly produce large quantities of biologic drugs.
How long until pharmaceuticals are widely 3D printed commercially? What are the key formulation considerations when applying 3D printing? Tune in to learn about all this and more...
A new paper details the GMP manufacturing and formulation process for a semi-synthetic Shigella glycoconjugate vaccine candidate from Institut Pasteur.
The €5.1 million will add a new chemical synthesis workshop for HPAPIs, expanding Novasep’s HPAPI production capacity at its Le Mans site in France.
The completed modernisation of Catalent’s facility in Limoges, France, will support the development of early phase and small-scale commercial biologic drugs.
Pfizer’s oral COVID-19 treatment nirmatrelvir will be produced by 35 generic manufacturers to increase supply for low- and middle-income countries.
Unveiling its Medicine Supply Map, the US Pharmacopeia (USP) showed how reliant the US pharma supply chain is on Indian API manufacturers.
A novel flow synthesis method using recoverable solvents will be used to supply NEt-3IB, an inflammatory bowel disease (IBD) drug candidate.
Under a new agreement with J&J, Aspen SA Operations will be able to manufacture and make available Aspen-branded COVID-19 vaccines in Africa.
The UK Government has committed £200mn to support NHS-led diagnostics and treatment research and £60 million to expand life sciences manufacturing.
In this article by IMA, discover how IMAGO software installed on rotary tablet presses supports scientists during tablet manufacturing, providing critical insights into powders.
The EDQM will include Real-Time Remote Inspections (RTEMIS) as an integral part of its system for the supervision of manufacturers of active substances from 2022.
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Brian Henry, Global Head of Drug Product Design at Pfizer, is the new Chair of the Medicines Manufacturing Industry Partnership (MMIP), a body representing the voice of medicines manufacturing in the UK.