Research shows the complexity and number of biologics is increasing, as is the frequency at which their active pharmaceutical ingredient (API) production is outsourced.
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Active Pharmaceutical Ingredient (API)
Learn about current and future European pharmaceutical supply chains from Richard Daniell at Teva Pharmaceuticals in European Pharmaceutical Review’s first podcast.
In this article, Rich Quelch, Global head of marketing at Origin, discusses how the UK’s pharmaceutical supply chain could be adapted to increase its resilience to future disruptions and the challenges in doing so.
The company will donate 450,000 vials of remdesivir and support its licencing partners in expanding and accelerating the production of the drug.
Case study example regarding finding impurities and controlling formations at release.
USP and Phlow have built a new laboratory to develop test methods and standards to facilitate broader adoption of continuous manufacturing in the US.
Manufacturing drug products with low solubility APIs (BCS type II and IV) has its challenges, in this article, Javier Gurrea, a Spray Drying Manufacturing Scientist at Idifarma, explains why spray drying offers a great way to overcome them.
Considerations when sourcing active pharmaceutical ingredients (APIs) can often be condensed to ones of economy and purity. Here, Dave Elder highlights the importance of defining those attributes that impact final product quality to ensure pharma companies find the best ingredient suppliers.
The Indian drug company pleaded guilty to concealing and destroying records containing evidence of its Kalyani plant manufacturing drugs in contravention to FDA requirements prior to a 2013 inspection.
Richard Daniell explains why Europe needs a strong pharmaceutical manufacturing base and supply chain to ensure a resilient network.
Active pharmaceutical ingredients (APIs) are primary components in the manufacture of drugs, yet this global market experiences numerous challenges. Regulatory pressure, pricing arbitrages, a shift to digital manufacturing and patents for blockbuster drugs are chief among them, but the COVID-19 pandemic added a further hurdle as governments globally decided to…
Within this in-depth focus are articles explaining the numerous benefits of in vitro human cell-based kidney models to study nephrotoxicity and drug-to-drug interactions as well as discussing the measures taken by API manufacturers to successfully navigate the pandemic and the opportunities this presents.
This issue focuses on whether our vaccine innovation capabilities will prepare us for future outbreaks, how Raman spectroscopy can be used to rapidly detect SARS-CoV-2 and the development of high-throughput glycoanalytics for biopharmaceuticals. Also included are articles on opportunities in the global API market and how to successfully identify defects…