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Biopharma 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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New quality requirements for tobacco products
Here, Dave Elder explores proposals for new FDA rules on tobacco product manufacturing. How could strategies for controlling tobacco-specific nitrosamines compare with those for nitrosamine drug substance-related impurities?
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EDQM 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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How 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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Cell and Gene Therapy Catapult opens new laboratories
Cell and Gene Therapy Catapult's new laboratories in Scotland aims to help cell therapy developers improve their manufacturing processes and navigate regulatory requirements.
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The cell and gene therapy CDMO bottleneck isn’t capacity – it’s capability
CDMOs have been squeezed by the sharp increase in companies preparing to scale their cell and gene therapy manufacturing for Phase III trials and commercialisation, and physical capacity has been a common scapegoat. But eXmoor CEO Angela Osborne says the real limiting factor is experience.
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Study identifies key contamination source during ATMP manufacture
Researchers say they are the first to demonstrate contamination of over 40 percent of lipoaspirate samples for adipose tissue-derived stem cell (ADSC)-based advanced therapy medicinal product (ATMP) manufacture.
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Analysis 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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Nivolumab plus chemo provides one-year PFS in 94 percent lymphoma patients
A PD-1 checkpoint inhibitor plus chemotherapy is expected to become new standard of care for advanced Hodgkin lymphoma, based on Phase III trial data.
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Novel PAT system could enable adaptive process control
A paper has demonstrated a novel refractometry-based process analytical technology (PAT) system has potential for enabling adaptive process control in CGT manufacturing.
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Sandoz to move headquarters to Basel, Switzerland
As Sandoz prepares to become standalone company, the generic and biosimilar firm has declared it will base itself in Basel, facilitating closer collaboration.
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New UK drug delivery centre to support RNA therapeutic development
To develop new lipid nanoparticle formulations for RNA therapeutic delivery technologies, CPI and partners are working to establish a new UK Intracellular Drug Delivery Centre.
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NICE recommends oral migraine treatment for first time
An oral small molecule CGRP antagonist has been recommended for episodic migraines in National Institute for Health and Care Excellence (NICE) final draft guidance.
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Microfluidic device detects bacteria concentration from small sample volumes
A novel ultrasonic nanosieve enabled concentration of bacteria into a 1µL highly concentrated solution suitable for plate counting and PCR, according to research.
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CRISPR-based microbial gene therapy delivers promise
A microbial gene therapy can “eliminate antibiotic-resistant E. coli strains in the gut”, according to first-in-human study interim results.
