In this week’s news, UK CPI to build small molecule centre, EU drops plan to add environmental risk assessments to GMP, US phage therapy facility and more…

CPI announces plans for small molecule focused innovation centre in UK

The UK Centre for Process Innovation (CPI) has announced plans for a £56m small molecule drug manufacturing centre (MMIC).

The facility – the Medicines Manufacturing Innovation Centre – will be located in Renfrewshire, Scotland. Activities will focus on the development of improving the production of active pharmaceutical ingredients (API) with the aim being to improve competitiveness.

A CPI spokesperson told us “As a key investment from the Industrial Strategy Challenge Fund, the MMIC builds on work taking place at centres across the UK to reduce the risk and accelerate the adoption of emerging and novel manufacturing technologies for the production of small molecule pharmaceutical and fine high value chemicals.

“This is expected to strengthen UK capabilities and expertise in medicines manufacturing making the UK a leader in technology and innovation in the sector.  Industry led, the MMIC aims to attract over £80 million of R&D investment by 2028 and create 80 high value jobs by 2023.”

Day to day operations will be led by the CPI in partnership with the University of Strathclyde, the Medicines Manufacturing Industry Partnership (MMIP), and founding industry partners, AstraZeneca and GSK.

Innovate UK, the UK’s innovation body that reports to the Department for Business, energy and industrial strategy, described the centre as a major investment in UK manufacturing. It also noted that continuous manufacturing will be a focus for innovation efforts at the facility.

Leaked doc suggests EU won’t include environmental risk assessments in GMP

Reports suggest the EU has scrapped plans to force drug firms to conduct environmental risk assessments as part of GMP.

According to the Guardian, leaked documents indicate that previous plans to introduce risk assessments at drug plants as part of an effort to slow the spread of antibiotic resistance have been abandoned.

The EU has not commented on the report.

Nusa Urbancic, a spokeswoman for the Changing Markets Foundation, told the paper: “We are shocked that the European commission seems willing to get rid of the option to include environmental criteria … so early on in the process, given the overwhelming evidence presented about how pharmaceutical pollution contributes to the proliferation of drug-resistant bacteria.”

Drug industry group EFPIA also noted the report, adding that it would respond more fully after the official publication of the document.

First phage therapy centre set up in US

UC San Diego has announced plans for a phage therapy centre to explore the idea of using bacterial viruses to fight infection.

Using viruses that infect bacteria – phage – to treat infection is not a new idea. The practice was commonly used in the Soviet Union, in part because antibiotics were in short supply.

The collapse of the Soviet Union saw the phage therapy fall out of favour. Now, however, growing concerns about antibiotic resistance have seen the approach gain in popularity.

The idea for the centre for Innovative Phage Applications and Therapeutics (IPATH) followed the successful treatment of university Prof. Tom Patterson who caught a multi-drug resistant bacterium in the Middle East.

“Comatose and dying, a team that included experts from UC San Diego, the U.S. Navy, Texas A&M University, San Diego State University and private industry developed experimental cocktails of bacteriophages to treat Patterson. The approach worked; Patterson awoke within days and fully recovered.”

IBI Lorenzini hires TraceLink for serialization compliance

Italian drug maker and CDMO IBI Lorenzini has hired TraceLink to help it comply with increasingly complex global drug serialization rules.

The deal, financial terms of which were not disclosed, will see TraceLink use its suite of cloud-based technologies ensure that products made by IBI are shipped in compliance with relevant track and trace regulations.

Also in the news

Propublica has asked is the US FDA is repaying the drug industry’s contribution to its budget by rushing the approval of ‘risky’ medicines.

CNBC reported that US conglomerate General Electric is poised to divest its GE Healthcare business.

The US FDA has approved a plasma manufacturing facility in Covington, Georgia set up by Shire. Read more at European Pharmaceutical Manufacturer.

The Medicines Maker has examined what impact US President Donald Trump’s plan to cut drug prices will have on patients.