In this week’s news, US Profs work on mini drug facilities, EU concerns about trial database delay, FDA warns about “hidden” facilities and more…
US scientists developing briefcase-sized drug making plants
Researchers across the US are developing ways of making drugs on-demand using miniaturised manufacturing systems according to a report in Nature.
The work – by academics at University of Maryland, Baltimore County (UMBC) and the Massachusetts Institute of Technology (MIT) in Cambridge, Virginia and elsewhere– involves developing techs that accelerate production and cut costs.
Traditional drug manufacture relies on economies of scale, mixing reagents in massive reaction chambers to make lots of doses.
In contrast, according to the scientists quizzed by Nature, miniaturised systems could be used to cycle small amounts of chemicals through small chambers and quickly produce thousands of doses of multiple drugs.
See the full article here.
EU Parliament concerned about delays to clinical trial database
The European Parliament says the roll out of the EU clinical trial database needs to be faster.
The Public Health and Food Safety (ENVI) expressed concerns about “delays observed in the development of the EU clinical trials portal and database.”
The database is intended to increase drug research transparency.
US FDA urges action on hidden drug and API facilities
The US FDA says 16% of ANDA applications have “hidden” facilities that are listed in drug master files but not the ANDAs with which they are associated.
The US regulator shared the information in a presentation this month. It also provided industry with tips to help bridge this information gap.
It said that communication between contract API suppliers and CDMOs and the companies they work for is key.
“This high number is indicative of poor communication between applicants and DMF holders regarding the DMF related facilities that support their ANDAs.”
Also in the news
The Wall Street Journal looked at the opening up of China’s pharmaceutical market.
Inside Health Policy reported about Government efforts to ensure the US pays less for drugs than other developed nations.
Under the original proposal, the International Pricing Index demonstration would have set payments for Medicare Part B drugs based on the average prices. Read more here (subscription required)
The ABPI has published its “manifesto” for the upcoming UK general election. Among other things, the industry group urged the next Government to strike a deal with the EU that maintains “the scientific, regulatory and trade infrastructure for the life sciences sector.”
Sanofi has significantly reduced the amount of water it uses to make its pharmaceutical products according to a report by Supply Chain Dive.
The NEJM looked at how industry has used the online clinical trial results database clinicaltrials.gov in the 10 years since it was launched.
Some developments of note in the contract manufacturing sector.
Particle Sciences has been rebranded as Lubrizol Life Science Health. Owner Lubrizol said the change reflected the CDMO’s incorporation into its life science business group alongside Lubrizol’s Personal, Home and Health Care business units.
The rebranding comes a few months after Lubrizol bought Bavaria Medizin Technologie GmbH, a German CDMO focused on intravascular and nonvascular medical devices.
CDMOs are benefitting from growing pharma interest in breakthrough therapies and orphan drugs according to a survey presented at CPhI. The report suggests the skills needed to make such product are becoming a huge revenue stream for contractors with experience and capacity.
Thermo Fisher Scientific has opened a customer solutions centre in Shanghai, China. The firm has also expanded its clinical trial logistics facility in Suzhou.
Fujifilm Diosynth Biotechnologies has announced plans to invest $55 million into its gene therapy business. The contractor said it would establish an innovation centre at its cGMP gene therapy manufacturing facility in College Station, Texas.