First-in-class biologic approved for rare lung disease
The biologic therapy offers a novel therapeutic option that targets a new treatment pathway in pulmonary arterial hypertension (PAH).
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The biologic therapy offers a novel therapeutic option that targets a new treatment pathway in pulmonary arterial hypertension (PAH).
A lack of standardised testing methods and subsequent delayed product approvals is limiting growth of the pyrogen testing market, according to a report.
At the Committee for Medicinal Products for Human Use (CHMP)’s March meeting, twelve medicines received positive opinions for marketing authorisations, including a new antibiotic and a novel oral medicine for a rare blood disorder.
An alternative in vitro pyrogen detection test using transfected THP-1 cells detected endotoxin and nonendotoxin pyrogens with good sensitivity, stability and predictability, a study shows.
22 March 2024 | By Rapid Micro Biosystems
Discover the extensive panel testing done to evaluate the new, innovative sterility testing platform, Growth Direct® Rapid Sterility.
The new acquisition is set to boost Lonza’s large-scale biologics manufacturing capacity for mammalian therapeutics.
This ebook explains how single-use filtration can support safer, more efficient biopharmaceutical production. Discover more on different filtration stages and unveil key characterisations, like pore size and membrane material, empowering tailored selection to specific biomolecules and processes.
Research predicts the global continuous bioprocessing market will witness a CAGR of 19.72 percent between 2024-2031.
Automating a Laboratory’s BET workstream using Lonza’s PyroTec® PRO Robotic Solution, WinKQCL® Software, and MODA® Software.
On World Kidney Day 2024, Dr Marshall Fordyce, CEO of Vera Therapeutics explores the challenges of treating kidney disease and shares why the company’s lead candidate could become the first self-administered B-cell modulation therapy.
In our third instalment of EPR's exclusive ‘Microbiome therapeutics: microscope to medicine’ series, Tue Hodal, Chief Technology Officer and Lorenz Rindisbacher, Chief Quality Officer, Bacthera, explore how live biotherapeutic products (LBPs) represent a transformative shift in medicine, highlighting their unique challenges and potential.
12 March 2024 | By Actylis
Join us as we look at how the outsourcing of buffers is helping biopharma drug manufacturers to streamline their processes.
8 March 2024 | By Thermo Fisher Scientific
Discover the valuable role ultraviolet-visible spectroscopy can play in quickly and accurately monitoring a drug as it moves through the research & development workflow and enabling quality and regulatory compliance through the manufacturing process.
The approval authorises the interchangeability of denosumab biosimilars in the US to treat primary and secondary bone loss.
Automating the pipetting steps of the PyroGene® rFC Assay on the ASSIST PLUS helps to reduce the opportunity for pipetting errors and ensures robust reproducibility.