According to research, increased in R&D investment for developing novel excipients and greater emphasis on patient-centric formulations are key drivers for the pharmaceutical excipients market.
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A subcutaneous C5 complement inhibitor has been authorised by the European Commission (EC) as a treatment for generalised myasthenia gravis in Europe.
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.
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.
A new 24-hour sterility testing method combining nanopore sequencing and machine learning could revolutionise sterility assurance in biopharmaceutical manufacturing of cell therapies.
In this exclusive 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.
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.
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.
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.
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.
This application note addresses the need to evaluate key sources of contamination to maintain an optimum level of pharmaceutical quality control.
Alexion’s intravenous enzyme replacement therapy has been recommended for the ultra-rare disease by the National Institute for Health and Care Excellence (NICE).