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European Pharmaceutical Review Issue 4 2023
EPR Issue 4 includes articles on fridge-free vaccines, dry powder drug delivery, Annex 1, contamination control strategy and more.
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Technology
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$2 billion mRNA-based oncology therapy market anticipated by 2029
As the pharmaceutical industry awaits the first regulatory approval of an mRNA-based oncology therapy, research predicts BioNTech will lead the market by 2029, which by then, is anticipated to value $2 billion.
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Meeting rising demands of a new radiotheranostic era
Targeted radiotheranostics are on the path to becoming integral to cancer diagnosis and treatment. Their success, however, depends on patient benefit and the ability to meet commercial demands for broader indications. Aside from the therapeutic or diagnostic efficacy, decisions on suitable radionuclide properties and owning the supply chain will be…
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IMA: the all-in-one solutions provider for complete vaccines lines
IMA Pharma showcases its extensive, all-in-one vaccine production solutions, including the design and development of complete aseptic lines and secondary packaging, all facilitated by the latest advanced technologies.
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Stem cell therapy delivers potential for sickle cell disease
A Novartis’ Phase I/II study for sickle cell disease trialling the gene therapy OTQ92 is the first treatment to target a new genetic area and use cryopreserved stem cells, according to new paper published in NEMJ.
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CGT manufacturing QC market to value $2.8b by 2031
Advanced analytical technologies in quality control (QC) processes in cell and gene therapy manufacturing is anticipated to help deliver a 24.6 percent market CAGR between 2023 and 2031.
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Roche subcutaneous cancer immunotherapy granted MHRA approval
The first subcutaneous anti-PD-(L)1 cancer immunotherapy available to patients in Great Britain on the NHS reduces treatment time to under ten minutes.
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Pharmaceutical migration study sampling procedure reported
A study incorporating new methodologies has described a stratified sampling procedure used for analyte response evaluation in pharmaceutical migration studies.
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UK medicines manufacturing to get innovation boost
A multi-million investment is set to enhance UK medicines manufacturing in three key areas: intracellular drug delivery, digitalisation and automation and nucleic acid medicines.
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New vaccine development centre to strength UK’s capabilities
The UK’s new vaccine development and evaluation centre will target pathogens for which a vaccine does not exist or could be improved, supporting pandemic preparedness.
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Astellas to advance oncology CAR-T therapy
An investment of $50 million by Astellas Pharma in Poseida Therapeutics’ Phase I allogeneic CAR-T product candidate for solid tumour indications is set to advance the cancer immunotherapy field.
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Antibiotic manufactured via continuous-flow for first time
Continuous-flow manufacturing of the antibiotic cefazolin can cover mass production within compact manufacturing facilities and contribute to a stable drug supply, researchers have reported.
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Next-gen sustainable inhalers on the horizon
Global development and manufacture of the next generation of green inhalers is positioned to be accelerated by a new joint £33 million government-industry investment.
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Accelerating biomanufacturing with automated PAT systems
Experts at Amgen have highlighted a micro sequential injection (µSI) process analyser and automatic assay preparation platform (A2P2) as an autonomous process analytical technology (PAT) platform to enable rapid testing and release of biopharmaceutical products.
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Innovation passport designation awarded to Pfizer and Arvinas
As the next stage of their co-development of vepdegestrant, the Medicines and Healthcare products Regulatory Agency (MHRA) has granted Pfizer and Arvinas its Innovation Passport to advance development of the oestrogen receptor (ER) degrader for ER+HER2- breast cancer.
