news
Demand for CROs expected to revive business activity to pre-pandemic levels
A new report has said that CROs are likely to resume their business activity in the second half of 2020 because of high demand.
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Outsourcing
news
Has pharma abused the US COVID-19 small business loans system?
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.
news
Research finds 25 percent of drugs contain highly potent compounds
A new report has said that a quarter of drugs globally are based on highly potent active pharmaceutical ingredients.
news
Serum Institute of India: outsourced manufacturing of COVID-19 vaccines
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.
news
Outsourcing facility opens highly potent compound manufacturing suite
The development of a highly potent active pharmaceutical ingredient (HPAPI) contract manufacturing facility has been completed in the US.
news
Few CMOs equipped to manufacture cell and gene therapies, finds study
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.
news
Indian CMO market hotbed for private equity investment, says report
A report suggests that India’s CMO market has recently attracted investment from global private equity firms due to favourable government policies.
news
FDA proposes four APIs for bulk substances list for outsourcing facilities
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.
webinar
The analytical reality of recombinant endotoxin technologies
29 July 2020 | By Charles River
In this webinar we discuss 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.
news
FUJIFILM Diosynth Biotechnologies to manufacture Novavax COVID-19 vaccine candidate
Novavax and FUJIFILM Diosynth Biotechnologies have agreed for FDB to make the bulk drug substance for NVX-CoV2373, the Novavax COVID-19 vaccine candidate.
article
Outsourcing update: the latest developments in pharma
European Pharmaceutical Review explores some of the latest developments in outsourcing, including clinical development and production agreements; acquisitions and collaborations; and expansions.
video
On-demand webinar: Outsourcing selected areas of the quality system
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
whitepaper
Application note: Nitrosamines by GC-MS in Valsartan
Determination of nitrosamines including gentoxic NDMA analysed by GC-MS in Valsartan using direct injection and headspace methods, below required LOD.
whitepaper
Application note: Organic acids in solutions by IC-MS
A simple, sensitive and selective direct method using IC coupled to a single quadrupole MS to analyse organic acids in drug solutions.
whitepaper
Application note: Nitrosamines in drug product by HRAM-LCMS
HPLC with HRAM MS method for the determination and quantitation of nitrosamine impurities in drug products consistent with FDA requirements.
