All Raw materials and supply chain (bioprocess) articles – Page 10
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NewsEMA prepares for winter antibiotic shortages
Anticipating similar demand of antibiotic use in prior winter seasons, the European Medicines Agency (EMA) has proposed key actions to mitigate supply chain issues.
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NewsFDA releases analysis on drug product quality in 2022
There continues to be a correlation between low site inspection scores and potential drug recalls, states the US Office of Pharmaceutical Quality (OPQ) 2022 annual report.
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ArticleReflecting on five years of quality control for nitrosamine impurities
Since the US Food and Drug Administration (FDA)’s report on a series of nitrosamine-related impurity drug recalls in 2018, pharma has made great strides in its ability to detect and control for these impurities. Dr Mrunal Jaywant, Vice President of R&D at USP India proposed a collaborative, cross-community approach between ...
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NewsUK trial to test psilocin-based drug for major depressive disorder
A first-of-its-kind trial testing a novel psilocin-based drug for major depressive disorder has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA).
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NewsFDA publishes recommendations on psychedelic clinical trial design
New draft guidance published by the US Food and Drug Administration (FDA) is intended to aid clinical study design in psychedelic drug development programmes.
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ArticleAMR certification: recognising responsibly in antibiotic manufacture
Following the recent launch of the BSI’s AMR certification, EPR invited Steve Brooks from the AMR Industry Alliance and BSI’s Courtney Soulsby to elucidate its significance for antibiotic manufacturers and the wider pharma industry.
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NewsBiopharma struggling to find talent with adequate digital skills
While there has been "strong progress" in addressing certain skills gaps, advancing tech like AI means biopharma are increasingly seeking talent with data skills, ABPI stated.
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NewsEDQM publishes annual report
Included in EDQM’s annual report were reflections on the 11th Edition conference, which highlighted key topics such as the potential of nanomedicines and Big Data.
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NewsHow can biopharma strengthen its resilience?
A recent report has found that since 2021, biopharma resilience has decreased, affecting areas such as supply chain, strength of the R&D ecosystem and manufacturing agility.
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NewsNew AMR certification launched for antibiotic manufacturers
Following publication of the Antibiotic Manufacturing Standard in 2022 to help overcome AMR, antibiotic manufacturers can now verify their actions through a new certification.
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NewsAnalysis reports nitrosamine prevalence in small molecule drugs
Data from a paper on small molecule drugs has indicated nitrosamines in pharmaceuticals is likely more prevalent than originally expected.
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NewsBig Pharma inventory management trends revealed
Rapid growth of Big Pharma manufacturer inventories fail to prevent medicine shortages, a 2022 report has highlighted.
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NewsAutomation to guide technology shift in aseptic environments
Referencing Annex 1–2022, a paper has described how automation will be implemented in aseptic environments in view of regulatory requirements.
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ArticleOvercoming bottlenecks in the advanced therapy supply chain
Professor Dr Martin Bornhäuser of University Hospital Carl Gustav Carus Technische Universität Dresden discusses the cell therapy bottleneck and why advanced therapy tracking systems could offer a solution.
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NewsNew recognition routes to fast-track UK medicine access
New recognition routes will facilitate faster and safer access to innovative medicines through seven international partners, according to the UK’s MHRA.
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NewsBenefits of blockchain in limiting counterfeit drug distribution
Smart contracts on blockchain could help prevent distribution of counterfeit drugs in the pharmaceutical supply chain, a review shows.
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NewsEMA guidance aims to prevent medicine shortages
The European Medicines Agency (EMA) has made recommendations for industry on how to prevent medicine shortages and reduce their impact.
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NewsBristol Myers Squibb boosts CAR T therapy manufacturing capabilities
Securing in-house viral vector production capabilities in the US is set to help Bristol Myers Squibb manufacture its two CAR T-cell therapies.
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NewsPharma responds to proposed EU pharmaceutical legislation reform
Industry bodies EPFIA and the Alliance for Regenerative Medicine and law firm Pinsent Masons have responded to the recent proposed revision of the EU pharmaceutical legislation.
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NewsModerna’s mRNA vaccine manufacturing centre begins construction
Moderna achieves another milestone in its UK government partnership, with the start of construction of its mRNA vaccine manufacturing centre.