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Novel drug delivery method shows promise in Alzheimer’s
Ultrasound combined with a biologic treatment has demonstrated the ability to safely reduce brain amyloid plaques in the brains of Alzheimer’s patients, a first-in-human study shows.
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Regulatory revision essential for bioprocess IIoT adoption
A limited number of Industrial Internet of Things (IIoT) applications exist in the bioprocessing industry and remain to be challenged in manufacturing operations, research has highlighted.
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Outsourcing regulatory activities in pharma
Here, EPR's Caroline Peachey explores some key considerations, approaches and strategies for pharmaceutical companies looking to outsource regulatory activities.
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Developing micro QC for ATMPs
In this Q&A, Natalie Saunders, Interim Head of Quality Control at CGT Catapult, delves into the advancements and challenges in microbiological QC for cell and gene therapies. She discusses rapid sterility testing methods, regulatory frameworks, and the impact of automation and digitalisation on quality control.
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Boehringer Ingelheim agrees $2bn siRNA therapeutic collaboration
The collaboration seeks to develop new siRNA treatments for the liver diseases nonalcoholic or metabolic dysfunction-associated steatohepatitis (NASH/MASH).
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Driving QbD as a quality standard in drug development
To facilitate Quality by Design (QbD) in becoming a true standard approach for drug development, pharma should attend regulatory expectations and pursue innovative frameworks that guarantee high-quality levels, researchers urge.
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AstraZeneca to advance haematology cell therapy
The new acquisition grants AstraZeneca rights to a new CAR-T cell therapy with a differentiated manufacturing process that could provide a potential best-in-class blood cancer treatment.
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NK cell immunotherapy: what’s next in clinical development?
In this interview, Innate Pharma’s Yannis Morel, Executive Vice President of product portfolio strategy and business development, delves into the unique advantages of using multi-specific antibodies capable of engaging NK cells against tumours for oncology indications, and shares key data from the company’s ongoing and recent clinical trials.
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Advancing AOCs to transform the delivery of RNA therapeutics
In this article, Dr Michael Flanagan discusses how a new class of medicines called antibody oligonucleotide conjugates (AOCs) have the potential to overcome a major challenge encountered with many established RNA-based therapeutics: delivery to tissues outside the liver. Last year, AOCs demonstrated the first-ever successful targeted delivery of RNA into…
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‘Innovation-first’ mindset vital for advanced therapies sector future
Improving data harmonisation and investing in the advanced therapy sector’s workforce are some of the key recommendations the sector must take to advance the field and increase patient access, a new report highlights.
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Antibody-immunotherapy combination shows promise in lung cancer
A study evaluating the combination of a PD1 inhibitor with dupilumab enabled one out of six lung cancer patients to achieve a near-complete clinical response two months post-treatment, a paper states.
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UK’s entrance into Horizon Europe finalised
The EU-UK Specialised Committee on Participation in Union Programmes has adopted the political agreement on UK’s association to the Horizon Europe programme.
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Innovative technologies facilitate novel contamination-detection method
A new 24-hour sterility testing method combining nanopore sequencing and machine learning could revolutionise sterility assurance in biopharmaceutical manufacturing of cell therapies.
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Cell and gene therapy: manufacturing and talent trends 2023
In this interview, Stephen Ward, Chief Manufacturing Officer and Jeanette Evans, Chief Business Officer, Cell and Gene Therapy Catapult, highlight key data from the organisation’s recent GMP Manufacturing Survey and Skills Demand reports, and present insight into the sector’s current and future landscape.
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Cold storage market to value $383bn by 2032
The combination of tech innovation, automation, and sustainability is reshaping the landscape of cold storage solutions, research says.
