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.
Novel mechanisms of action discovered for the skin cancer medication Imiquimod
21.10.2016 | Technische Universität München
Second research flight into zero gravity
21.10.2016 | Universität Zürich
Researchers from the Institute for Quantum Computing (IQC) at the University of Waterloo led the development of a new extensible wiring technique capable of controlling superconducting quantum bits, representing a significant step towards to the realization of a scalable quantum computer.
"The quantum socket is a wiring method that uses three-dimensional wires based on spring-loaded pins to address individual qubits," said Jeremy Béjanin, a PhD...
In a paper in Scientific Reports, a research team at Worcester Polytechnic Institute describes a novel light-activated phenomenon that could become the basis for applications as diverse as microscopic robotic grippers and more efficient solar cells.
A research team at Worcester Polytechnic Institute (WPI) has developed a revolutionary, light-activated semiconductor nanocomposite material that can be used...
By forcefully embedding two silicon atoms in a diamond matrix, Sandia researchers have demonstrated for the first time on a single chip all the components needed to create a quantum bridge to link quantum computers together.
"People have already built small quantum computers," says Sandia researcher Ryan Camacho. "Maybe the first useful one won't be a single giant quantum computer...
COMPAMED has become the leading international marketplace for suppliers of medical manufacturing. The trade fair, which takes place every November and is co-located to MEDICA in Dusseldorf, has been steadily growing over the past years and shows that medical technology remains a rapidly growing market.
In 2016, the joint pavilion by the IVAM Microtechnology Network, the Product Market “High-tech for Medical Devices”, will be located in Hall 8a again and will...
'Ferroelectric' materials can switch between different states of electrical polarization in response to an external electric field. This flexibility means they show promise for many applications, for example in electronic devices and computer memory. Current ferroelectric materials are highly valued for their thermal and chemical stability and rapid electro-mechanical responses, but creating a material that is scalable down to the tiny sizes needed for technologies like silicon-based semiconductors (Si-based CMOS) has proven challenging.
Now, Hiroshi Funakubo and co-workers at the Tokyo Institute of Technology, in collaboration with researchers across Japan, have conducted experiments to...
14.10.2016 | Event News
14.10.2016 | Event News
12.10.2016 | Event News
21.10.2016 | Health and Medicine
21.10.2016 | Information Technology
21.10.2016 | Materials Sciences