In this week’s news, EC looks at borderline drug/device products, pharma urged to pay more attention to CDMO quality oversight and more.

EC advises manufacturers of “borderline” drug/device products

The European Commission has issued new guidelines for developers and contract manufacturers that make products that could either be considered a drug or device.

The Commission’s Medical Device Co-ordination Group set out recommendations to help firms working on these so called “borderline” products this week, explaining the aim is to allow developers identify the correct regulatory pathway.

See RAPS’ coverage for more details.

Invest in quality management when outsourcing say, experts

Drug companies that outsource to CDMOs need to invest in the development of quality management systems according to an Op-ed published by Bioprocess Online this week.

The article – by regulatory compliance and project management experts Penelope Przekop and Valerie Przekop – suggests management of outsourcing contracts is becoming harder as industry moves towards a more decentralized drug development a production model.

“Outsourcing and technology have morphed our industry into a new decentralized model. Now, each sponsor must carefully develop an ongoing compliance strategy considering its unique business model and its influence on the drug development journey,” according to the authors.

They go on to outline several key strategies, details of which are available here.

US FDA outlines common ANDA problems for drug firms and CDMOs

The FDA has outlined common problems that trip up generic drug companies and the CDMOs they work with in a new report

The comments which were made at an event last week – available here – are based on cases when the agency used its refuse-to-receive (RTR) mechanism in 2021.

According to the FDA many major deficiencies were related to inadequate stability data and insufficient Q1/Q2 sameness studies with the reference-listed drug (RLD).

Full details are available here.

Also in the news

Enpoints looked at the Serum Institute of India which revealed that production of COVID-19 vaccine has been halted since December.

In related news the New York Times reported that efforts to vaccinate people against COVID-19 in low income countries are stalling.

Sanofi has teamed with McLaren Racing to look at ways of accelerate manufacturing efficiency and performance at its drug plants.

AstraZeneca has announced plans to open a new site at the heart of the Cambridge, MA, life sciences and innovation hub.

BeiGene has started work on a new manufacturing and clinical R&D center at the Princeton West Innovation Campus in Hopewell, N.J.

Purolite achieves Queen’s Award for Enterprise, It’s one of 232 organisations in the country to be recognised with the award

CDMO trends

Some developments of note in the contracting sector: 

Grand River Aseptic Manufacturing has signed a multi-year contract with the US HSS and Department of Defense under which it invest $160 million and receive $120 million from the U.S. government to fund the expansions of its filling and finishing facilities.

Catalent has acquired Erytech Pharma’s commercial-scale cell therapy manufacturing facility in Princeton, New Jersey, for $44.5 million. The deal includes an exclusive long-term supply agreement.

The firm has also completed a significant expansion of its nasal drug product manufacturing capabilities at its Morrisville, Research Triangle Park (RTP), North Carolina.

Societal CDMO has been contracted by the National Cancer Institute’s Division of Cancer Treatment and Diagnosis (DCTD) to produce and package $400,000 of ammonium tetrathiomolibdate (ATTM) capsules for trials.

WuXi Advanced Therapies has partnered with A*star to make its proprietary Tetracycline-Enabled Self-Silencing Adenovirus technology available to cell and gene therapy developers in to the Asia-Pacific region.