The mAb tislelizumab has been granted approval from Chinese authorities, making Boehringer Ingelheim Biopharmaceuticals the first MAH under the new system.
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The US Food and Drug Administration (US FDA) defines complex generics as products having intricacy associated with an active pharmaceutical ingredient(s) (API), formulation process, route of delivery, or drug-device combination.
A recent industry report projects a boom in the biosimilars market over the next three years and highlights key considerations for meeting its potential.
Over the last few years, biologics have continued to make up an increasing proportion of biopharmaceutical sales and pipeline candidates. Cory E Muraco and Wayne Way discuss current trends in biologics analysis.
At CPhI (Frankfurt, November 5-7 2019), Telstar will be promoting the latest solutions in isolation technology systems, sterilisation and pharmaceutical freeze-drying applications, designed to ensure an aseptic and efficient production of pharmaceutical processes.
A Biologics License Application and priority review has been approved by the FDA for an investigational Ebola vaccine.
Nucala is the first biologic approved in the US for six- to 11-year-old children with severe eosinophilic asthma by the FDA.
Purification of a drug from host cell protein contaminants can be challenging, with low-level contamination often remaining after purification. Vanda Dolabela de Magalhães shares discussions on the subject from six Brazilian companies working in the biotech field.
ADVANCES in biotherapeutics are generating an increasing range of complex molecules that present unique and often complex purification challenges.
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.
The Parenteral Drug Association (PDA) has recently published Technical Report No. 82 (TR82) on the topic of Low Endotoxin Recovery (LER), providing both consensus to the science and data behind the analytical issue, as well as to analytical and mitigation strategies.
Scientific poster: Nuvia aPrime 4A: a hydrophobic anion exchange resin for refined selectivity and recovery
The elimination of product and process related impurities is essential to the safety and efficacy of biopharmaceuticals.