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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.
Many pharmaceutical and biotech companies outsource their product development and manufacturing. In this article, experts from Simon-Kucher & Partners explain why smart offer design and costing is key to commercial success for CDMOs.
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The market is expected to grow at a 6.7 percent CAGR, driven by the increasing prevalence of cancer and cardiovascular diseases, as well as growing interest in biologics.
In this issue we discuss whether clinicians know enough about the development of biosimilars to buy in, explore the biggest M&A trends in pharma and what to expect this year and consider the importance of disaccharides in the stabilisation of biologics. The journal also features articles on the fundamentals of…
In this ebook, discover innovative solutions for three core areas of drug development: drug formulation, scale-up and analysis with hot melt extrusion; quality control and validation using microscopic and spectroscopic instruments; and instrumentation for nucleic acid quantification and qualification.
Collaborators on Grand Challenge 3 will utilise their combined expertise to transform the oligonucleotide supply chain.
The review will evaluate data from preclinical and clinical studies of NVX-CoV2373 to expedite the vaccine’s marketing authorisation approval later.
The UK Government has ordered a further 40 million doses of Valneva’s COVID-19 vaccine candidate, to be manufactured in Scotland.
The company announced that the Phase I/II trial for VLA2001 is now fully enrolled and that it has begun manufacturing the vaccine candidate on an industrial scale.
Reports have said five people have been killed in a fire at the Serum Institute of India, where the Oxford-AstraZeneca COVID-19 vaccine is being made.
Richard Daniell explains why Europe needs a strong pharmaceutical manufacturing base and supply chain to ensure a resilient network.
The agreement is expected to advance the commercial-scale manufacturing of the NVX-CoV2373 to enable it to be distributed across Europe following regulatory approval.
This article shares the results from an evaluation of a novel thermal imaging technology that took place before the initial implementation in a Pfizer manufacturing facility. The manuscript describes the technology and reviews the extensive process used to challenge its inspection capabilities through field testing. Finally, the potential benefits of…
Researchers have developed a novel high-throughput method for the detection of glycans in purified biopharmaceutical samples. In this article, Victoria Smith, Lewis Wharram and Stuart Jamieson discuss their innovative approach and the implications for safety and potency assurance in biopharmaceuticals.
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…
