List view / Grid view
While each pharmaceutical validation provides the necessary foundation for the testing of specific products via recombinant Factor C (rFC) without external reference, there are also several published studies that support the equivalence of recombinant technology.
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.
While we all know that COVID-19 has promoted growth in the vaccine contract manufacturing market, what other factors are impacting the field? In this article, EPR summarises the trends and opportunities identified by a new market research report.
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.
![The GlaxoSmithKline headquarters building in Brentford, west London, June 2018 [Credit: Willy Barton / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/GSK-3-300x278.jpg)
![The GlaxoSmithKline headquarters building in Brentford, west London, June 2018 [Credit: Willy Barton / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/GSK-3-e1624534468322.jpg)
In an investor update, GlaxoSmithKline (GSK) revealed its plan to promote growth and performance over next ten years.
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.
Endotoxin automation using microfluidics enables simpler, compliant processes for pharma QC, QA, validation and IT. BET assay setup is simplified and less LAL is required.
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.
The journey from large molecule to approved biotherapeutic is long, costly, complex and fraught with risk – yet rewards for success are substantial.
Endotoxin automation doesn’t mean complex instrumentation and setup. See how microfluidics enables easy BET assay setup so QC labs achieve high throughput with less hands-on time.
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 Crystalline offers the possibility to quickly obtain data on the stability of protein formulations by making use of the real time digital camera.
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.
