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Alexion to expand biologics manufacturing with €65m investment
The investment in new drug substance production equipment and warehousing facilities to enhance Alexion’s biologics manufacturing in Ireland.
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Biologics
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Webinar: Responsibilities of specialised clinical supply experts
Learn the differences in areas of expertise and responsibilities between the Clinical Supply Manager, Project Manager and Financial Project Analyst.
whitepaper
Whitepaper: Bridging the cell and gene therapy gap
The current understanding among sponsors of the workflow from cell collection, to manufacturing, and to the clinical site for patient administration.
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Heparin affinity chromatography promising for extracellular vesicle purification
Researchers find that heparin affinity chromatography (HAC) produces highly pure extracellular vesicles with greater recovery than existing purification methods.
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Final positive results of Zolgensma® trial for SMA published
After previous reports that nearly all spinal muscular atrophy (SMA) patients treated with Zolgensma® achieved key motor milestones, Novartis announces publication of full SPR1NT results.
news
Machine learning model enables adventitious agent detection in cell cultures
Researchers have developed a rapid, label-free process analytical technology, called the anomaly detection model, to monitor microbial contamination in cell cultures in near-real-time.
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WTO waives intellectual property rights for COVID-19 vaccines
According to IFPMA, the World Trade Organization decision to waive intellectual property rights for COVID-19 vaccines fails to tackle the biggest barrier to access: trade.
whitepaper
Survey report: Direct-to-patient: industry perception and future trends
Understand the perceived importance of DTP to successful study execution.
news
Detecting and eradicating mycoplasmas in ATMP cell lines
Here, EPR summarises the key points of Tim Sandle’s recent review of mycoplasma risks, detection and eradication techniques for cell cultures.
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New Berlin site to accelerate cell therapy innovation for BlueRock Therapeutics
BlueRock Therapeutics LP has established a new site for cell therapy innovation on Bayer’s campus in Berlin, Germany.
whitepaper
Resources: Single use technologies – the ultimate future
Single use technologies is highly booming in biopharmaceutical sector due to its efficient use and benefits.
news
Are closed systems the future of CGT sterility testing?
Researchers have identified, for the first time, a sensitive, low-risk, closed-system for the detection of fungal contaminants in cell and gene therapy (CGT) products.
whitepaper
Article: Outsourcing biologics: key considerations
PCI’s Tim Roberts discusses key factors when outsourcing the clinical and commercial supply of biologics, and what makes a strong CDMO partnership.
whitepaper
Case study: Reduce plate counts with rapid microbial monitoring
Find out how a pharma company maintained product quality and reduced plate counts by 25 percent using a rapid microbial monitoring analyser – the 7000RMS.
news
Update on setting occupational exposure limits
Here, EPR summarises a recent review, outlining the critical considerations when setting occupational exposure limits (OELs), with a focus on HPAPIs.
