Single-use technology propelling upstream bioprocessing market expansion
European Pharmaceutical Review
by Catherine Eckford
16h ago
A report from Data Bridge Market Research has predicted that the upstream bioprocessing market will value $14,256.78 million by 2029. Additionally, the research calculated that market is anticipated to undergo a CAGR of 6.85 percent between 2022 and 2029. The rising productivity of cell lines has improved the performance of upstream processing with low cost and high process reproducibility, the report explained. Key factors driving the upstream bioprocessing market The upstream bioprocessing market has benefited from evolutions in manufacturing such as the shift from simple stainless-ste ..read more
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WHO initiative to enhance biomanufacturing in LMICs
European Pharmaceutical Review
by Catherine Eckford
1d ago
The World Health Organization (WHO) has launched a new Biomanufacturing Workforce Training Initiative to help overcome challenges within the biomanufacturing sector in low- and middle-income countries’ (LMICs). The programme aims to support the limited capacity within the industry in LMICs. Another goal of the initiative is to manage the shortage of a qualified workforce in the production of biological products, such as vaccines, and monoclonal antibodies (mAbs).   What will the biomanufacturing initiative involve? Discussing its Biomanufacturing Workforce Training Initiative, the W ..read more
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Novel immunotherapy approved for melanoma
European Pharmaceutical Review
by Catherine Eckford
2d ago
Amtagvi (lifileucel) is the first tumour-derived autologous T cell immunotherapy therapy to be approved by the US Food and Drug Administration (FDA) for certain adults with unresectable or metastatic melanoma” Amtagvi (lifileucel) is the first tumour-derived autologous T cell immunotherapy therapy to be approved by the US Food and Drug Administration (FDA) for certain adults with unresectable or metastatic melanoma. It is also the first non-CAR-T adoptive cell therapy to reach the market. Based on the FDA’s approval, lifileucel is indicated in those who have previously has been treated with ..read more
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Overcoming challenges of continuous antibody manufacture
European Pharmaceutical Review
by Catherine Eckford
4d ago
Researchers have highlighted the potential of end-to-end continuous manufacture with column-free capture alternatives. The traditional batch process was compared with end-to-end continuous bioprocesses with either protein A (ProA) capture or column-free capture, employing aqueous two-phase extraction (ATPE) or precipitation from economic, environmental, and robustness perspectives. Since monoclonal antibodies (mAbs) represent the fastest growing biopharmaceutical market segment, according to Neves et al., they are a “prime” test option for continuous manufacturing. Continuous column-free alte ..read more
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New chemotherapy treatment could benefit multiple cancer types
European Pharmaceutical Review
by Catherine Eckford
6d ago
A clinical trial in malignant pleural mesothelioma (MPM) has demonstrated the first successful combination of chemotherapy with a drug targeting cancer’s metabolism developed for the asbestos-induced disease in two decades. The anti-cancer treatment combines the new drug ADI-PEG20 and traditional chemotherapy. The Phase III ATOMIC-meso trial was led by Queen Mary University of London in the UK and studied 249 patients with the disease. Data from the study showed that [the combination of ADI-PEG20 and traditional chemotherapy] quadrupled the survival [of malignant pleural mesothelioma] partic ..read more
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Gilead plans $4.3 billion deal to advance liver portfolio
European Pharmaceutical Review
by Catherine Eckford
6d ago
Gilead Sciences has agreed to acquire CymaBay Therapeutics for a total equity value of $4.3 billion. Gilead confirmed that CymaBay’s lead product candidate seladelpar has a best-in-disease profile for second-line primary biliary cholangitis (PBC). This is based on data from the Phase III RESPONSE trial. The company shared that seladelpar is an oral, selective peroxisomeproliferator-activated receptor delta (PPARδ) agonist. Clinical studies have demonstrated its potential in regulating genes involved in bile acid synthesis, inflammation, fibrosis and lipid metabolism, storage, and transport. I ..read more
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Pharmaceutical suspension market to witness accelerated growth
European Pharmaceutical Review
by Catherine Eckford
1w ago
A report by Allied Market Research predicts that the global pharmaceutical suspension market will reach $83.8 billion by 2032. Having valued $55.5 billion in 2022, the research expected that the market will reach a CAGR of 4.2 percent between 2023 and 2032. Factors driving the global pharmaceutical suspension market One of the main factors anticipated to propel the growth of the pharmaceutical suspension market is the availability of generic pharmaceutical suspensions, the research asserted. The research specified that the parenteral administration sector accounted for more than half of the g ..read more
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Navigating the unique CMC challenges of oral anaerobic live biotherapeutics
European Pharmaceutical Review
by Catherine Eckford
1w ago
The development of drug products containing live anaerobic bacterial strains as the active pharmaceutical ingredient and where potency and shelf-life is typically associated with viable cell quantification, poses unique challenges when compared to both small and large molecule development therapeutics. It is the uniqueness of the strain and perceived inter-cellular variations (sub-populations) resulting from high viable cell densities during growth (fermentation) and the subsequent harvest and downstream processing of cells that gives rise to batch-to-batch variations. Achieving drug substanc ..read more
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USP recommends revisions to proposed RMM chapters
European Pharmaceutical Review
by Catherine Eckford
1w ago
In January, United States Pharmacopeia (USP) published revisions to previous drafts of chapters about using rapid microbiological methods (RMM), with a specific focus on short-life products. <72> Respiration-Based Microbiological Methods for the Detection of Contamination in Short-Life Products The changes for the proposed chapter the detection of contaminants in short-life products. With ‘significant’ revisions from previous versions, it is based on the version published in PF 46(6) as “Respiration-Based Rapid Microbial Methods for the Release of Short Shelf Life Products”. According t ..read more
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Vertex secures European approval for CRISPR cell therapy
European Pharmaceutical Review
by Catherine Eckford
1w ago
The first CRISPR/Cas9 gene-edited therapy has been granted a marketing authorisation by the European Commission (EC). Vertex Pharmaceuticals’ CASGEVY (exagamglogene autotemcel [exa-cel]) is conditionally approved individuals 12 years and over with severe sickle cell disease characterised by recurrent vaso-occlusive crises or transfusion-dependent beta thalassemia. The cell therapy is indicated in those for whom hematopoietic stem cell (HSC) transplantation is appropriate and a human leukocyte antigen matched related HSC donor is not available. Significance of the novel approval This condition ..read more
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