The NICE committee has made palbociclib with fulvestrant available on the Cancer Drug Fund for patients with hormone receptor-positive, HER2-negative, advanced breast cancer.
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Authorisation has been granted in the UK for the STEADFAST clinical study of TX200, which is the first-in-human trial to evaluate a CAR-Treg cell therapy.
Developing a stable therapeutic protein formulation requires an intimate knowledge of the protein and its physical and chemical properties. In this article, Bernardo Perez-Ramirez and Robert Simler discuss the thermodynamic consequences that low temperature can have on the aggregation tendencies of a protein.
Researchers have used nanoparticles to infuse a non-opioid drug into nerves to provide enhanced pain relief.
A new process developed by the University of Bath protects a TB antigen and a novel vaccine adjuvant from heat damage.
Researchers have detailed recent breakthrough experiments that successfully immunised mice against the Candida auris infection.
Whitepaper: Impact of the Claristep® Filtration System on recovery and adsorption of various therapeutic proteins at low sample volumes
Comparison of the Sartorius Claristep Filtration System with standard sample preparation using syringe filters.
Expert View: Eshmuno® CP-FT resin – developed for the flow-through removal of aggregates using frontal chromatography
Eshmuno® CP-FT cation exchange resin is specifically designed to provide efficient removal of monoclonal antibody (mAb) aggregates in the flow-through frontal chromatography mode of operation enabling loading capacities 10-times higher than traditional bind/elute CEX chromatography. It facilitates greater manufacturing flexibility and process intensification while reducing the overall cost for the…
The process of manufacturing a biotherapeutic drug entails numerous quality control measures to ensure safety and efficacy. The articles in this in-depth focus discuss higher order structure analysis and host cell protein contamination issues.
A new drug for Huntington disease is found to be safe and lowers levels of the abnormal protein that causes the debilitating disease in patients.
18 April 2019 | By SUEZ
TOC analysis is a widely adopted method for detecting residual product or cleaning agents on manufacturing equipment. Compared to specific methods such as HPLC, TOC can provide better process understanding and efficiency for cleaning validation (CV), verification and continuous monitoring...
Matrix-assisted laser desorption/ionisation (MALDI) time-of-flight (TOF) mass spectrometry (MS) has proven to be an excellent technique for identification of illegally distributed peptides and proteins for human use. The identification of proteins is mainly based on peptide mass fingerprinting (PMF) – ie, the bottom-up approach – while the small proteins and…