All Raw materials and supply chain (bioprocess) articles – Page 10
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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.
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NewsPioneering malaria vaccine gains regulatory clearance
University of Oxford-developed R21/Matrix-M malaria vaccine has secured approval in two African countries.
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ArticleEuropean Pharmaceutical Review Issue 2 2023
EPR Issue 2 includes articles on the future of cell and gene therapy, the potential of AAV gene therapies, NMR relaxometry and more…
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NewsYescarta® demonstrates promising European manufacturing experience
In newly published analysis, Kite's CAR T-cell therapy delivered a reduced median European manufacturing turnaround time for diffuse large B-cell lymphoma (DLBCL) patients.
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ArticlePharma within planetary boundaries
Regulatory changes along a drug’s lifecycle should ensure that the health benefits of pharmaceuticals, which have a large ecological footprint, do not cost the environment. Dorothea Baltruks, Research Associate at the Centre for Planetary Health Policy, outlines how forthcoming EU pharmaceutical legislation could pave the way to solutions.
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Webinar
The hidden costs of microbial misidentifications
Doug Botkin, PhD, examines the challenges and consequences of inaccurate microbial identification methods using real-world case studies and discusses how these challenges can be addressed.