news
Novel generalised myasthenia gravis treatment approved
A subcutaneous C5 complement inhibitor has been authorised by the European Commission (EC) as a treatment for generalised myasthenia gravis in Europe.
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Biopharmaceuticals
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Challenging applications of capillary electrophoresis in biopharmaceutical analysis
After decades of development and refinement, the separation of proteins by capillary electrophoresis (CE) has moved beyond the R&D laboratory into the manufacturing quality control laboratory. Here, Giuseppe Peddio and Federica Bisceglia discuss the advancements in CE technology for development applications and batch release for biopharmaceutical products.
news
AbbVie agrees $10 billion oncology acquisition
Under its proposed acquisition of ImmunoGen, AbbVie will gain rights to ELAHERE®, the first antibody-drug conjugate (ADC) approved in ovarian cancer.
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Drug development trends: insight from Thermo Fisher’s Anil Kane
In this interview, Anil Kane, Executive Director and Global Head of Technical & Scientific Affairs, Pharma Services, at Thermo Fisher Scientific discusses innovations in oral delivery of biologics, the rising popularity of prefilled syringes as well as global pharma trends in regulation and manufacturing.
news
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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mRNA therapies: a new frontier
Nicolas Chornet, Senior Vice President of International Manufacturing at Moderna, speaks to EPR about the future of mRNA therapies and offers an update on the company’s international expansion plans.
news
Ferring reveals long-term data for cancer gene therapy
New data from a Phase III gene therapy trial has demonstrated a 90 percent three-year overall survival rate for its participants with a high-risk bladder cancer.
news
Pharma unites to secure renewable energy in key manufacturing markets
The new industry collaboration aims to help decarbonise the global supply chain by focusing on the energy-intensive pharmaceutical manufacturing that takes place in China and India.
whitepaper
Application note: Equivalency of PCR-based rapid sterility testing and the compendial culture method
Sterility testing is a critical component of release testing for any cell therapy product since microbial contamination of cell therapy products can potentially kill recipients.
whitepaper
Product hub: Choosing the right tool for method screening and process optimisation
CIM® Monolithic Well Plates combine the advantages of monolithic chromatography with the convenience of a standard well plate format. They ensure robustness and reliable results, making them ideal for screening multiple chromatographic conditions simultaneously.
news
Could stem cell therapy stabilise MS progression?
Positive findings from a first-in-human trial means that an advanced cell therapy for progressive multiple sclerosis will be evaluated in Phase II.
whitepaper
Application note: Role of in-house isolates in pharmaceutical quality control
This application note addresses the need to evaluate key sources of contamination to maintain an optimum level of pharmaceutical quality control.
news
First treatment recommended for infants with Wolman Disease
Alexion’s intravenous enzyme replacement therapy has been recommended for the ultra-rare disease by the National Institute for Health and Care Excellence (NICE).
news
Long COVID study expanded across Europe
If biotech Berlin Cures’ larger Phase III study of its Long COVID drug candidate goes ahead, the findings will support the treatment’s potential future regulatory approval.
