David Vosvenieks, REACH issue manager at AstraZeneca (AZ), told Chemistry & Industry that two companies supplying intermediates required for two AZ drugs – one of them an anticancer therapy– have already warned AZ that they may no longer be able to guarantee supply under the new rules. Pfizer and GlaxoSmithKline have also said they are in discussions with suppliers.
REACH, which could come into force next April, poses a serious threat to supplies of large numbers of intermediates and raw materials used in drug manufacture. ‘While the possibility of this happening has always been on our radar, this has come as a rude awakening,’ Vosvenieks said.
A change in supplier would mean re-submitting a drug for evaluation by the regulatory authorities. And because a lot of current manufacture is driven by demand, many drug companies would not have stockpiles to cover the re-authorisation period, which according to the UK Medicines and Healthcare products Regulatory Authority could take up to two months. In the worst-case scenario this could mean a delay with restarting supply.
A spokesman for Pfizer, the world’s largest pharmaceutical company, admitted the company was also in discussions with suppliers over REACH, but declined to say whether any particular products were affected. GSK is also reviewing suppliers, but a spokesman said that they had not come up against any problems to date.
‘Finding a new supplier would be very much a last resort, and would potentially bring extra costs,’ Vosvenieks said. Pharmaceutical active ingredients (APIs) are largely exempt from REACH, but many of the solvents and intermediates involved in the manufacture of the final drug formulation will not be. The main chemicals affected will be hazardous chemicals such as carcinogens or mutagens. ‘Such compounds may be used in 5 -10% of drug syntheses as a very rough estimate,’ according to Vosvenieks.
Many of the smaller or more specialist firms producing them may lack the resources to comply with REACH.
Rainbow colors reveal cell history: Uncovering β-cell heterogeneity
22.09.2017 | DFG-Forschungszentrum für Regenerative Therapien TU Dresden
The pyrenoid is a carbon-fixing liquid droplet
22.09.2017 | Max-Planck-Institut für Biochemie
Plants and algae use the enzyme Rubisco to fix carbon dioxide, removing it from the atmosphere and converting it into biomass. Algae have figured out a way to increase the efficiency of carbon fixation. They gather most of their Rubisco into a ball-shaped microcompartment called the pyrenoid, which they flood with a high local concentration of carbon dioxide. A team of scientists at Princeton University, the Carnegie Institution for Science, Stanford University and the Max Plank Institute of Biochemistry have unravelled the mysteries of how the pyrenoid is assembled. These insights can help to engineer crops that remove more carbon dioxide from the atmosphere while producing more food.
A warming planet
Our brains house extremely complex neuronal circuits, whose detailed structures are still largely unknown. This is especially true for the so-called cerebral cortex of mammals, where among other things vision, thoughts or spatial orientation are being computed. Here the rules by which nerve cells are connected to each other are only partly understood. A team of scientists around Moritz Helmstaedter at the Frankfiurt Max Planck Institute for Brain Research and Helene Schmidt (Humboldt University in Berlin) have now discovered a surprisingly precise nerve cell connectivity pattern in the part of the cerebral cortex that is responsible for orienting the individual animal or human in space.
The researchers report online in Nature (Schmidt et al., 2017. Axonal synapse sorting in medial entorhinal cortex, DOI: 10.1038/nature24005) that synapses in...
Whispering gallery mode (WGM) resonators are used to make tiny micro-lasers, sensors, switches, routers and other devices. These tiny structures rely on a...
Using ultrafast flashes of laser and x-ray radiation, scientists at the Max Planck Institute of Quantum Optics (Garching, Germany) took snapshots of the briefest electron motion inside a solid material to date. The electron motion lasted only 750 billionths of the billionth of a second before it fainted, setting a new record of human capability to capture ultrafast processes inside solids!
When x-rays shine onto solid materials or large molecules, an electron is pushed away from its original place near the nucleus of the atom, leaving a hole...
For the first time, physicists have successfully imaged spiral magnetic ordering in a multiferroic material. These materials are considered highly promising candidates for future data storage media. The researchers were able to prove their findings using unique quantum sensors that were developed at Basel University and that can analyze electromagnetic fields on the nanometer scale. The results – obtained by scientists from the University of Basel’s Department of Physics, the Swiss Nanoscience Institute, the University of Montpellier and several laboratories from University Paris-Saclay – were recently published in the journal Nature.
Multiferroics are materials that simultaneously react to electric and magnetic fields. These two properties are rarely found together, and their combined...
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