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Fact sheet: 5 Secrets to a successful cleaning validation program
Here are five ways to ensure a successful and compliant cleaning validation program.
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Gene therapy
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Fact sheet: TOC monitoring efficiency quiz
Take our 10-question quiz to find out how efficient your Total Organic Carbon (TOC) monitoring programme is for your applications.
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News: Microbial solutions product portfolio updates
Charles River provides essential products and services to help pharmaceutical and biotechnology companies, government agencies and leading academic institutions around the globe accelerate their research and drug development efforts.
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A crucial turning point for increasing patient access to ATMPs
Numerous developments are ongoing to make advanced therapy medicinal products (ATMPs) more accessible, effective and less expensive. Here, legal experts Robert Stephen and Jane Hollywood from CMS discuss the increasing prevalence of these highly regulated therapies and the challenges faced by innovators in this space.
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SMA drug Zolgensma® has “significant therapeutic benefit”, according to interim data
Treatment with Zolgensma® (onasemnogene abeparvovec) resulted in rapid and sustained improvement in motor function in spinal muscular atrophy (SMA) patients.
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Few CMOs equipped to manufacture cell and gene therapies, finds study
A report has said that with only 152 CMOs able to manufacture the 7,000 cell and gene therapies in the pipeline, production bottlenecks may occur.
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A glimpse at how Novartis’ manufacturing and supply organisation responded to COVID-19
The rapid evolution of the COVID-19 situation has created significant barriers to normal operations, from locking down borders to the imposition of restrictions on trade and export – not to mention a surge in demand for many common medicines. Each of these events in isolation can affect production and supply,…
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Data sheet: Viral RNA extraction from saliva and swab samples
RNAdvance Viral Kits. High-quality RNA extraction from saliva or swab transport media. Automation ready. LoD demonstrated at 1 copy/μL.
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Application note: Streamlined synthetic biology with acoustic liquid handling
Reduce input sample to femtomolar levels. Miniaturise gene assembly reactions up to 100-fold. Streamline NGS verification of assembly.
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Application note: Miniaturised multi-piece DNA assembly
The Echo Liquid Handler has demonstrated the ability to generate DNA constructs using various assembly chemistries with a miniaturised protocol.
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Whitepaper: Rapid sterility testing: a new solution for short shelf life products
All drug products have to undergo sterility testing to comply with Good Manufacturing Practices (GMP). Rapid sterility testing, which offers an incubation period of five days or less, provides a solution.
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MRC and LifeArc announce grants for Gene Therapy Innovation Hubs in UK
The UK MRC and LifeArc are making £16 million available as grants to fund the establishment of Gene Therapy Innovation Hubs to improve resources for researchers and manufacturers.
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Emerging biotechs tackle medical research continuity concerns amid COVID-19
While medical professionals fight COVID-19 on the front line, small biotech businesses face a new uphill battle – maintaining research continuity for non-COVID-19 life-changing therapeutics.
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Novel antibody delivery method could improve precision medicine
Scientists have developed a protocol for encapsulating antibodies in an ultrasound-sensitive drug carrier for targeted drug delivery.
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Study suggests Zolgensma will generate $2.5bn of global sales by 2025
According to researchers, Zolgensma, made by Novartis, will lead the global spinal muscular atrophy market and generate billions in sales.
