Years in the making, ACRES launches a global accreditation program, which will ‘dramatically’ benefit all research stakeholders, including sponsors, CROs, regulators, monitors, as well as patients, says CEO.
Accinov has teamed up with Canadian clinical research organisation (CRO) Biodextris to provide a transatlantic biomanufacturing ‘plug and play’ service for biopharmaceuticals—with a particular expertise in vaccines.
The agency issued a warning letter and withdrew the GMP (Good Manufacturing Practice) certificate from Hyderabad, India-based Sri Krishna Pharmaceuticals for 10 GMP deviations found during an inspection at its Nacharam granulation plant in December.
A Canadian subsidiary of India’s largest CMO (contract manufacturing organization) was cited by the US FDA for failing to investigate rejected batches of product or implement further preventive actions.
The Chinese SFDA has found that four batches of rabies vaccine produced by Jiangsu Yanshen contained insufficient quantities of API and is investigating the conduct of some employees, according to Simcere.
After getting through a difficult 2006, separation technology
specialist Whatman has made it through to the end of the year,
reporting preliminary annual financial results and looking towards
a more prosperous 2007.
Bruker AXS, a subsidiary of the Bruker BioSciences Corporation, has
announced an agreement to purchase Roentec, an x-ray microanalysis
instrumentation company that signals Bruker's intention to
reinforce its standing within this...
A suite of optical detection methods, developed by Finnish
researchers alongside world number two drugmaker GlaxoSmithKline,
promises to cut the cost of drug production and increase the safety
and quality of medicinal products.
PANalytical, a supplier of analytical instrumentation and software
for X-ray diffraction and X-ray fluorescence spectrometry, has
expanded ibnto Asia with the opening of a Regional Application
Laboratory in Shanghai, China.
The use of chemical imaging as a quality control measure for
mixtures of pharmaceutical ingredients before tabletting has taken
a step forward with the first deployment of a prototype system at
Pfizer that is currently in the process...
Materials testing specialist Stable Micro Systems has launched a
texture analysis device which promises to increase productivity and
improve cost-effectiveness where higher volume, repetitive quality
testing is required.
The rapid growth in the development and commercialisation of new
biological entities (NBEs) has been one of the major trends in the
pharmaceutical sector over the last few years, but their production
can be said to be more of an art...