US outsourcing organisation GRAM is set to undertake the aseptic fill and finish manufacture of J&J's COVID-19 vaccine candidate.
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A new report has said that CROs are likely to resume their business activity in the second half of 2020 because of high demand.
A review suggests some large pharma companies were approved to receive paycheck protection program (PPP) loans that were intended to help small US businesses to pay workers during the COVID-19 pandemic.
A new report has said that a quarter of drugs globally are based on highly potent active pharmaceutical ingredients.
As the COVID-19 pandemic and the search for an effective preventative vaccine continues, the Serum Institute of India has entered into manufacturing agreements with both Novavax and Codagenix to help supply their experimental COVID-19 vaccine candidates.
The development of a highly potent active pharmaceutical ingredient (HPAPI) contract manufacturing facility has been completed in the US.
A report has said that with only 152 CMOs able to manufacture the 7,000 cell and gene therapies in the pipeline, production bottlenecks may occur.
A report suggests that India’s CMO market has recently attracted investment from global private equity firms due to favourable government policies.
Four APIs are being considered by the FDA for its bulk drug substances list for potential use by outsourcing facilities when compounding if there is a clinical need.
29 July 2020 | By Charles River
In this webinar we will be discussing the results of our latest study where we evaluated the ruggedness, repeatability and specificity of commercially available rFC products, as well as our own recombinant product in development, against a large panel of endotoxins.
Novavax and FUJIFILM Diosynth Biotechnologies have agreed for FDB to make the bulk drug substance for NVX-CoV2373, the Novavax COVID-19 vaccine candidate.
European Pharmaceutical Review explores some of the latest developments in outsourcing, including clinical development and production agreements; acquisitions and collaborations; and expansions.
Former MHRA inspector Rachel Carmichael discusses outsourcing areas of your quality system including what would drive this decision, aspects of the operation that can be supported and measures to facilitate the process
Determination of nitrosamines including gentoxic NDMA analysed by GC-MS in Valsartan using direct injection and headspace methods, below required LOD.
A simple, sensitive and selective direct method using IC coupled to a single quadrupole MS to analyse organic acids in drug solutions.