All Therapeutics articles – Page 38
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NewsWHO initiative to enhance biomanufacturing in LMICs
A new World Health Organization (WHO)-driven initiative aims to enhance bioproduction capabilities for biological products in low- and middle-income countries (LMICs).
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NewsNovel 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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NewsOvercoming 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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NewsNew chemotherapy treatment could benefit multiple cancer types
The innovative treatment significantly increased survival in patients with malignant pleural mesothelioma, a rare, aggressive cancer, according to Phase III data from UK researchers.
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NewsNelson 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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Webinar
Process analytical technology: applications and opportunities for pharma
During this virtual panel, industry experts will discuss the latest advances and applications of process analytical technology in the pharmaceutical sector.
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ArticleTaming cardiovascular risk: the promise of LDL cholesterol lowering therapeutics
In this exclusive interview, CEO of NewAmsterdam Pharma, Michael Davidson, offers insight into the low-density lipoprotein (LDL) cholesterol lowering therapeutic landscape and shares promising data from the company’s lead candidate, a cholesterol ester transfer protein (CETP) inhibitor.
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NewsPharmaceutical suspension market to witness accelerated growth
The global pharmaceutical suspensions market is set to value $83.8 billion by 2032, due to the systems having key benefits such as supporting patient compliance.
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ArticleNavigating 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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NewsUSP recommends revisions to proposed RMM chapters
Revisions for two proposed USP chapters recommend changes for rapid tests required for releasing sterile short-life products, as well as for rapid microbiological methods (RMM) for detecting contamination in these products.
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NewsVertex secures European approval for CRISPR cell therapy
Now conditionally approved in Europe for sickle cell disease and transfusion-dependent beta thalassemia, the CRISPR therapy offers eligible patients a functional cure.
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NewsRaman 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.
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ArticleBiologics – 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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NewsBioNTech 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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NewsInhalable 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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NewsNext-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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NewsEMA 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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NewsSuanfarma 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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NewsNovo 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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NewsUS 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.