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Sanofi adds to biomanufacturing investment in France
The pharmaceutical company shared that its new investment adds to the current €2.5 billion planned for major building projects in France.
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Research & Development (R&D)
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Addressing drug delivery challenges of emerging drug modalities
The new company will work to develop solutions to overcome issues within new therapeutic modalities, in areas such as formulation, manufacturing and supply chain.
webinar
Pharmaceutical continuous manufacturing: what’s next for industry?
13 May 2024 | By European Pharmaceutical Review, sponsored by MasterControl
During this virtual panel, industry experts will discuss adoption of continuous manufacturing in the pharmaceutical industry.
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mRNA cancer vaccine granted world-first approval
Once commercialised, the mRNA therapeutic cancer vaccine will offer a new option to treat advanced Epstein–Barr virus-positive solid tumours and haematologic malignancies.
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Improving accuracy of spectroscopy for protein analysis
A study on spectroscopy challenges during biosimilar analysis has highlighted a novel observation with potential implications for quality control when detecting protein structures.
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Novel preservation method could improve storage of biologics
Light-assisted drying (LAD) is a new optical processing technique for forming trehalose amorphous solids to preserve biologics, while avoiding the freezing step necessary for lyophilisation.
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US agencies collaborate to address regulation for biotechnology products
In formulating the current Coordinated Framework for the Regulation of Biotechnology, the US Food and Drug Administration (FDA), US Environmental Protection Agency (EPA) and the US Department of Agriculture (USDA) utilised horizon scanning for novel biotechnology products.
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Dissolution of capsule with cross-linking
In this article, Jigar Shah, Senior Group Leader in Analytical Development at Baroque Pharmaceuticals, explores the intricacies of capsule dissolution testing.
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Key vaccine adjuvant biosynthesised in yeast
According to research, the yeast-based process could not only make one of the most effective adjuvants more widely available, but also help lower the cost of vaccines overall.
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Potential best-in-class antibody shows “remarkable efficacy” in atopic dermatitis
Interim trial results show that the only clinical-stage nondepleting anti-OX40 monoclonal antibody (mAb) provided rapid skin sign improvement in atopic dermatitis (AD).
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Pioneering the next wave of LBP-based therapeutics
Christopher Weidenmaier, PhD, Chief Scientific Officer, and Johannes B. Woehrstein, PhD, Chief Technology Officer at mbiomics share with EPR about the challenges and considerations of manufacturing microbiome-based therapeutics.
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Intravesical drug delivery system exhibits bladder cancer benefit
The drug delivery system provides local release of erdafitinib and may offer an alternative treatment for eligible bladder cancer patients with limited options.
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MHRA approves new medicine formulations for HIV prevention
The authorised formulations are a tablet and a long-acting injection used for preventing sexually transmitted HIV-1 infection (pre-exposure prophylaxis (PrEP).
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“Landmark” genetic blindness CRISPR trial outcomes released
A Phase I/II trial has shown that a CRISPR-based gene editing therapy can be safely delivered to the retina and provide clinically meaningful outcomes.
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Alternative methods for mycobacterial testing in biological products
Considering the limited available information on implementing mycobacterial testing for quality control of biologicals, researchers have highlighted a suitable potential alternative detection method.
