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Survey report: Direct-to-patient: industry perception and future trends
Understand the perceived importance of DTP to successful study execution.
List view / Grid view
Biologics
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.
news
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.
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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.
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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.
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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.
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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.
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ebook: Proactive clinical supply planning
The importance of thoroughly planned resupply strategies in maintaining clinical supply inventories as studies move into late phase.
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Article: Clinical and commercial outsourcing
The demand for biologics and high potent medicines is forcing the industry to consider alternatives, such as outsourcing and integrated solutions.
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Early phase CGT trials: key design elements correlating to distinctive biological characteristics
With increasing numbers of cell and gene therapies (CGTs) entering clinical trials, Dr Dave Li and Dr Anna Baran of KCR Consulting discuss how the biological characteristics of CGTs should be taken into account with early phase trial designs.
news
GSK to acquire Affinivax for MAPS vaccine platform
GSK will pay up to $3.3 billion to acquire Affinivax, gaining access to its Multiple Antigen Presenting System (MAPS) technology and pneumococcal vaccine candidates.
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Collaboration between Lonza and IBF to progress Israeli biologics sector
Israel Biotech Fund (IBF) and Lonza announce agreement to accelerate the development and manufacture of Israeli biologics and small molecules.
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Bavarian Nordic signs supply contract for smallpox vaccine as monkeypox cases rise
The agreement between Bavarian Nordic and an undisclosed country aims to ensure sufficient supply of smallpox vaccine to meet the country’s requirements for vaccinating individuals at risk for monkeypox.
podcasts
EPR Podcast Episode 11 – Developing vaccine technologies – Giulia Giordano and Mark Doherty, GSK
Why is vaccine manufacturing becoming more biological? How could Generalized Modules for Membrane Antigens (GMMA) enhance vaccinology? What developments have there been in adjuvant systems? Discover all this and more in this podcast with GSK experts.
