The US FDA has published a 483 detailing the violations it observed during an inspection of stem cell firm Celltex Therapeutics in April and the document does not make for comfortable reading.
The Hamner Institutes for Health Sciences and private equity firm PBM Capital Group (PBM) have thrashed out a venture for toxicity testing which they say could save the drug discovery industry billions.
CellCura has inked an agreement with IDT Biologika for the testing and adaptation of its protein-free (PF) media for the production of cell lines for vaccine manufacturing.
CMO Angel Biotechnologies has called in UK-based engineering group WH Partnership to help re-commissioning its GMP standard biomanufacturing facility in Cramlington near Newcastle-upon-Tyne.
Planning the commercial production and delivery of effective cell therapies will be key if the sector is to achieve forecast growth of $6bn within nine years, according to a seminar at the InterPhex trade event in New York City.
French contract research organisation (CRO) CIT will work on in vitro toxicity testing for pharmaceutical and cosmetic ingredients as the newest member of the European “ScreenTox” network.
Beta-Pro is addressing rising demands from drug discovery and research institutes in the hepatocyte market by expanding its site at the University of Virginia Research Park, US, with a new GLP facility.
Suzhou Erye, a subsidiary of NeoStem Pharmaceutical, has passed inspection by the Chinese Food and Drug Administration (SFDA) meaning the company's new manufacturing facility will go ahead with the manufacture of penicillin and cephalosporin powder...
Beike Biotechnology has opened a stem cell storage and processing facility at the 20,000 sq m regenerative medicine base in China, furthering the nation’s development in the field.
New Synthemax synthetic growth matrix promises improved scalability for large-scale hESC production which, say developers Geron and Corning, will cut cost of cell therapy manufacture.
ISCO’s stem cell manufacturing facility has passed final building inspection, enabling it to implement the processes and cGMP standards needed to produce clinical-grade products.
Angel Biotechnology has inked a deal to manufacture the CTX stem cell line, which can now be frozen and thawed when needed, at its dedicated cell-based therapies plant that is equipped and licensed for the task.
Stemedica Cell Technologies’ new license to make stem cells for trials positions the firm as a “valuable resource for front line researchers,” according to VP of business development Dave McGuigan.
Demand for downstream processing products from biotechs drove the continued recovery of Millipore’s bioprocessing division in Q2 but operating income remained flat.
Pfizer’s development deal with stem-cell researchers at University College of London’s (UCL) Institute of Opthalmology, aimed at reversing vision loss in AMD, has drawn a great deal of interest from investors and the drug industry alike.
Construction of a new stem cell research and processing plant began yesterday in China’s Eastern Jiangsu province as part of a joint project between the Chinese government and Shenzen Beike Biotechnology.
Alastair Riddell, CEO of UK firm Stem Cell Sciences (SCS), says the US governments’ reversal of the ban on federally funded stem cell research “opens up a market that was inhibited, restrained and impeded under the Bush administration.”
The US green light for federally funded embryonic stem cell research is being hailed as a victory by the US drug industry, which predicts it will open the flood gates for novel medications and help revitalise the sector.
The US Food and Drug Administration (FDA) gave the go-ahead to the first clinical trials of a stem cell-based therapy late last week, in a major boost to the development of the technology.
UK researchers have developed two synthetic molecules that coax stem cells to differentiate into either neurons or epithelial cells for use in drug discovery applications.
Japanese scientists have derived ‘embryonic’ stem cells from tissue taken from discarded human wisdom teeth, potentially bypassing the ethical dilemma of taking them from embryos.
Stemcell Technologies has launched a new well plate that promises to enable researchers to improve the process of differentiating stem cells into mature cell lines.
People employed in the pharmaceutical industry in New Jersey, USA fell by one per cent in 2007, according to a report by the HealthCare Institute of New Jersey (HINJ).
UK researchers have used the ReNcell VM stem cell line, licensed by Millipore from UK stem cell therapy experts ReNeuron, to model neural degeneration observed in Parkinson's disease.
Nanopoint has launched the 'world's most advanced' on-microscope cell containment device that offers complete environmental control for time-lapse cell imaging applications.
Three of the world's biggest pharmaceutical companies have signed a
landmark deal with the UK government that will see them use stem
cell technology to road-test the safety of new compounds.
The burgeoning US contract assay services arena has witnessed the
arrival of a brand new player with the launch of ReachBio, which is
opening its business operations this week.
The launch of Invitrogen's Stempro EZPassage should substantially
reduce the time and stress involved in dividing up cultures of
human embryonic stem cell (hESC) colonies.
A new study has shown that certain human bone marrow stem cells can differentiate into sperm stem cells - potentially leading to a revolution in fertility therapy.
Cellartis has begun a new research programme in Scotland as part of
a £9.5m (€14.5m) programme by ITI Life Sciences to develop the
world's first automated process to produce high-quality human stem
cells.
ReNeuron remains confident that its new stem cell therapy for
stroke will be approved to start clinical trials, despite a request
for further information from the industry regulator.
The UK's Human Fertilisation and Embryology Authority (HFEA) has
called for a public consultation into the use of animal eggs to
create cloned hybrid or chimeric human embryos for laboratory-based
disease research.
Researchers at the University of Rochester and StemCapture have
unveiled a new device technology that makes it possible to harvest
stem cells from the blood, bypassing the controversial use of stem
cells sourced from embryos.
Scientists have discovered stem cells in the amniotic fluid that
surrounds the foetus in pregnant women, bypassing ethical concerns
over the source of the versatile cells.
