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Raman and machine learning show promise for online monitoring of bioreactors
The approach applied in the research on bioreactors represents a significant advancement over traditional methods, according to the researchers.
List view / Grid view
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.
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Inhalable dry powder drug formulation could treat respiratory infections
The drug formulation study offers promise for treating different respiratory tract infections using a single antimicrobial agent, a paper reports.
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Next-in-class combination treatment shows potential in cystic fibrosis
Phase III trials have found CFTR modulator vanzacaftor/tezacaftor/deutivacaftor (vanza triple) to be non-inferior to TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in improving cystic fibrosis lung function.
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EMA Annex 1 Q&A discusses bioburden considerations
In its recent responses to FAQs relating to Annex 1, the European Medicines Agency (EMA) discusses bioburden guidelines for good manufacturing practice (CGMP) and good distribution practice (GDP).
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Suanfarma realigns brand to showcase innovative spirit
The new identity of Suanfarma’s industrial brands signifies integration of its manufacturing sites as part of Suanfarma CDMO.
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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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US legislation to benefit small molecule drug innovation
Passing of two key legislations in the US is set to support innovation for small molecule drugs and the biotech sector, Biotechnology Innovation Organization (BIO) asserts.
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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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Biogen refocuses its Alzheimer’s strategy
Part of Biogen’s prioritisation of its portfolio includes focusing on the advancement of its leading anti-amyloid beta Alzheimer’s treatment, LEQEMBI® (lecanemab-irmb).
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BCMA CAR T therapy facilitates potential autoimmune breakthrough
First use of a BCMA CAR T-cell therapy for immune-mediated necrotising myopathy (IMNM), enabled sustained depletion of autoantibodies beyond 18 months, a study shows.
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NICE recommends injectable bispecific antibody for aggressive blood cancer
Recommendation of AbbVie’s bispecific antibody for NHS use is based on a Phase I/II trial, which observed a 62 percent overall response rate in diffuse large B-cell lymphoma (DLBCL) patients.
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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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Immunotherapy drug achieves trial-first in fifty years
Major findings from a Phase III trial show that using immunotherapy drug pembrolizumab post-surgery extended survival and delayed disease recurrence in kidney cancer.
