whitepaperWhitepaper: EU GMP Annex – sterile manufacturing22 March 2021 | By Reading Scientific Services LimitedThis whitepaper considers the latest EU GMP Annex 1 draft and its impact on the control and release of sterile products.
newsbluebird bio releases new data on its gene therapy for cerebral adrenoleukodystrophy16 March 2021 | By Hannah Balfour (European Pharmaceutical Review)Data from nearly seven years of follow up suggests one-time treatment with eli-cel may durably stabilise cerebral adrenoleukodystrophy disease progression.
newsCRISPR therapies could be one of the most transformative in human history, says GlobalData16 March 2021 | By Hannah Balfour (European Pharmaceutical Review)Adam Pearson, Senior Oncology Analyst at GlobalData, comments on the development of CRISPR-based therapies and outlines potential opportunities and challenges in the space.
newsNICE approves gene therapy for spinal muscular atrophy9 March 2021 | By Hannah Balfour (European Pharmaceutical Review)Zolgensma, a one-off, potentially curative treatment for type 1 spinal muscular atrophy, is set to become the most expensive drug ever approved for use on the UK’s NHS.
whitepaperWhitepaper: Early product characterisation mitigates risks in biologics development4 March 2021 | By MerckProduct characterisation facilitates easier process design to ensure the biological drug attains critical product safety, purity, and potency.
videoVideo series: The champions of iCON: A collaborative discussion on global turnkey solutions (Part 2)3 March 2021 | By G-CON Manufacturing Europe LtdiCON has improved delivery capacity by standardising the infrastructure for a flexible and readily available drug manufacturing facility.
videoVideo series: The champions of iCON: A collaborative discussion on global turnkey solutions (Part 1)3 March 2021 | By G-CON Manufacturing Europe LtdiCON has improved delivery capacity by standardising the infrastructure for a flexible and readily available drug manufacturing facility.
whitepaperApplication sheet: Mobile testing LabPODs2 March 2021 | By G-CON Manufacturing Europe LtdReadily deployable, fully integrated mobile testing labs for fast-track delivery of diagnostic and analytical lab capability where and when needed.
whitepaperWhitepaper: Transmissible disease defense unit2 March 2021 | By G-CON Manufacturing Europe LtdThe use of flexible mobile biocontainment and test units to prevent the spread of transmissible diseases.
articleEMA’s transformative treatments of 202024 February 2021 | By Hannah Balfour (European Pharmaceutical Review)In this article, we summarise the trial findings for the European Medicines Agency’s 13 most transformative therapies of 2020.
videoVideo: Single versus multilayer film in cold chain bioprocessing19 February 2021 | By EntegrisOur video highlights how Aramus™ bag assemblies overcome single-use bag failures at cold temperatures with a new single-layer fluoropolymer material.
newsGates Foundation to fund Novartis’ development of a sickle cell disease gene therapy19 February 2021 | By Hannah Balfour (European Pharmaceutical Review)The Gates Foundation will fund Novartis’ discovery and development of a gene therapy for sickle cell disease that is accessible for low- and middle-income countries.
newsMarketing of Zynteglo suspended as precaution due to potential cancer risk19 February 2021 | By Hannah Balfour (European Pharmaceutical Review)bluebird bio has chosen to suspend sales of Zynteglo while they investigate whether safety concerns identified with a related investigational gene therapy may apply to the licenced medicine.
whitepaperFact Sheet: Process analytical technology and real-time TOC testing of pharmaceutical grade water systems18 February 2021 | By SUEZLearn how Process Analytical Technology (PAT) and real-time TOC testing of pharmaceutical grade water systems can improve efficiency.
whitepaperCatalogue: Standard cleanroom POD16 February 2021 | By G-CON Manufacturing Europe LtdG-CON’s standard POD maximises efficiencies in production, qualification and cost and eliminates the complexity of cleanroom construction projects.
