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Glycosylation of therapeutic proteins is important to biologic drug development and is a critical quality attribute that is monitored during manufacturing. Analysis of O-glycans is technically challenging compared to that of N-glycans. In this review, Xiaofeng Shi, Saulius Vainauskas and Christopher H Taron summarise current O-glycan analytical approaches, describe the…
Dave Elder outlines how bioequivalence data supports numerous processes at various stages of drug development as well as when establishing generic drug substitution, and reflects on its differing interpretations across the globe.
In this in-depth focus, find out about the key points to consider when implementing new software in the pharma development space and the current positions of the EMA and FDA with regards to nitrosamine contaminants.
Researchers anticipate the growth of the aging population and rising investment in biologic drugs to promote the expansion of the global active pharmaceutical ingredient (API) market.
In this journal, features on the current regulatory positions on nitrosamine impurities, how investing in off-patent medicines can help drive innovation and why new regulations could lead to a biosimilar boom in the UK. Other articles include an exploration of the challenges in developing and delivering lipid nanoparticle mRNA-based vaccines,…
A South African consortium will be the first to establish a COVID-19 mRNA vaccine technology transfer hub to scale up vaccine production and access.
German oncology clinics are working with Optima Pharma to create an automated manufacturing unit for decentralised production of CAR T-cell therapies in treatment centres.
The Cell and Gene Therapy Catapult’s new consortium aims to accelerate therapeutic development by developing process analytical technologies (PAT) for cell and gene therapy manufacturing.
EU recommends that batches of Janssen COVID-19 Vaccine not be released for use due to a cross contamination report, while the FDA authorises use of drug substance from the facility where the contamination occurred.
DFE Pharma is the latest member of the UK’s Medicines Manufacturing Innovation Centre and will work on Grand Challenge 1: improving the manufacture of oral solid dosage medicines.
South Africa and India’s request that the World Trade Organization waive intellectually property rights for COVID-19 vaccines, treatments, diagnostics and technology has garnered extensive media coverage, particularly since the US decision to support the proposal. In a three-part series, European Pharmaceutical Review’s Assistant Editor, Hannah Balfour, will discuss the IP…
In this article, Giacomo Chiesi from Chiesi Group outlines why the company took steps to become Benefit Corporation and B Corp certified, how this status may impact business and the associated operations.
The continuous-flow microfluidic device allows scientists to assess crystalline API growth rates, shapes and structures to more quickly identify the best conditions for drug manufacturing.
![MIT chemical engineers have devised a new way to formulate hydrophobic drugs by turning them into a nanoemulsion, which can be poured into a mold and dried into tablets. The nanoemulsion can also be used to form small particles, seen in the vials [Credit: Felice Frankel].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/MIT-HYDROPHOBIC-DRUGS-nanoemulsion-300x278.jpg)
![MIT chemical engineers have devised a new way to formulate hydrophobic drugs by turning them into a nanoemulsion, which can be poured into a mold and dried into tablets. The nanoemulsion can also be used to form small particles, seen in the vials [Credit: Felice Frankel].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/MIT-HYDROPHOBIC-DRUGS-nanoemulsion-e1623151984970.jpg)
Using a new formulation technique, researchers were able to more than double drug loading of a hydrophobic active pharmaceutical ingredient in tablets. Thus, the new formulation method may lead to smaller pills delivering the same therapeutic benefit.
In this article, Dr Ash Ramzan, principal consultant at Woodley BioReg, discusses the five key challenges preventing biosimilars from reaching their full potential.
