This week in pharma… 13th June

Ramarketing news round-up 

In this week’s news, a US CDMO is vital for theranostics approval, CDMOs interested in industry 4.0 need to understand how to implement tech US and more.

A US CDMO with good infrastructure is vital for theranostics success say researchers

Finding a CDMO with the right infrastructure is vital for firms developing theranostic therapies according to new research.

The study – published in the World Journal of Nuclear Medicine this week – looked at how EU-based developers can increase the chances that candidate theranostics – nano-size or molecular-level agents serving for both diagnosis and therapy – win approval in the US.

According to the authors “Early identification of a US CDMO with comprehensive and integrated manufacturing and pharmacy services, strong isotope supply chain, sophisticated logistics and quality system, and a substantial track record has been critical to the U.S. success of EU sponsor programs.”

Adopting Pharma 4.0 is about more than tech says expert

CDMOs are showing interest in adopting an “industry 4.0” to manufacturing, however, simply embracing the idea of data-driven production is only the first step.

Industry’s move towards digital manufacturing – which was discussed in an editorial in Contract Pharma this week – is driven by a desire for great efficiency and reduced cost.

But going digital is more involved that simply buying new bioprocessing systems according to the authors, who suggest that contractors that want to move in a digital direction need to change established processes.

“Enterprises hoping to pursue Pharma 4.0 quickly learn that digitalizing their technology transfer processes is a key strategic priority. Many life science companies today remain mired in a siloed, high latency and paper-based mindset—and eliminating these hurdles to technology transfer is a foundational step in pursuing digital transformation across the value chain.”

Read the full article here.

Also in the news

The Law Blog took a look at the US FDA’s sequential resumption of its inspection activities at CDMO and drug industry manufacturing plants.

Contract Pharma quizzed Pfizer’s contracting arm about emerging trends in the third-party manufacturing sector.

Eli Lilly and Company announced plans to expand its manufacturing footprint in Indiana by investing $2.1 billion in two new manufacturing sites at its campus in Boone County.

STAT looked at problems at two of Novartis’ cancer drug manufacturing facilities.

Seqirus has announced that its manufacturing facility in Holly Springs, North Carolina, has successfully achieved all criteria required to establish domestic manufacturing capability for cell-based seasonal and pandemic influenza vaccines.

Sana Biotechnology has entered into a lease agreement to develop an 80,000 square foot manufacturing facility in Bothell, Washington. 

The EMA has adopted its first list of critical medicines for COVID-19. 

CDMO trends

Some developments of note in the contracting sector: 

Lonza has added a dedicated early phase clinical manufacturing facility at its small molecules site in Bend, Oregon. 

Stevanato Group has acquired a new industrial complex in Cisterna di Latina, Italy.

mAbxience will equip its cGMP facility in León, Spain with an additional ABEC 4,000L CSR bioreactor to increase its CDMO business and capacity.

Coriolis Pharma is expanding its current headquarters to form a new Campus in the Fraunhoferstrasse in Martinsried-Munich.

Vernal Biosciences has announced the completion of a $21 million financing to fully integrate its mRNA manufacturing solutions.