In this week’s news, major UK investment by contract manufacturing firm, engineering group warns of oligo capacity crunch if CDMOs do not invest and more.

CRB says small biotech firms most likely to outsource

Biopharmaceutical focused CDMOs are likely to see more work from smaller companies than large firms according to new analysis by engineering consultants, CRB.

The firm made the prediction in a report last month, suggesting that larger biopharmaceutical developers are more likely to favour keeping production work in-house than their smaller counterparts in the biotech space.

“We believe that protecting intellectual property (IP) may also play a role because larger companies have a lot to lose if their IP gets out—and more resources to protect that IP by keeping it in-house. For start-up companies, there is nearly an equal split for in-house vs. CDMO manufacturing—with capital cost being the strongest driver.”

Oligo crunch?

The CRB team also raised concerns about capacity limitations for the manufacture of oligonucleotide based therapies.

They wrote, “Currently, there are only a handful of large-scale oligo contract manufacturers in the world—and they’re all booked through at least the end of 2022. It is possible that the CDMO market is falling behind in supplying oligonucleotide companies the production capacity required.

“Since CDMOs don’t tend to invest until they have sufficient demand, facility capacity won’t be available unless the biopharma companies build it for themselves. At the same time, oligo producers don’t want to be at the mercy of CDMOs in terms of production schedules, pricing, and supply chain.”

See the full report here.

Also in the news

Bioprocess Insider took a look at developments at Lonza, Abzena and Samsung in a busy week for the CDMO space.

Generic drug industry organisation Medicines for Europe wants the EU to relax “extreme cost containment policies” against non-branded drugs medicines, arguing that the put supply chains at risk. See press release.

CNBC reported that the omicron variant of the SARS-CoV-2 virus that causes COVID-19 has been found in 23 countries.

In related news the European Commission has issued a new document covering challenges created by novel SARS-CoV-2 variants.

RAPS covered the ICH’s review of activities in 2021, including the organisation’s work on drug manufacturing quality systems.

The EMA has shared its vision for how real world evidence will feed into its decision making processes. A few days later the US FDA released similar guidelines.

Contract Pharma looked at trends in the third party packaging services sector with input from Sweden’s Recipharm.

CDMO trends

Some developments of note in the contracting sector:

Nykode Therapeutics AS, formerly Vaccibody, has hired BioConnection to make its lead vaccine candidate. See press release.

Fujifilm Diosynth Biotechnologies will spend £400 million to expand its facility in Billingham, Teesside in the UK. See announcement.

In related news Fujifilm Irvine Scientific plans to set up an Innovation and Collaboration Center in Suzhou New District, China. See Contract Pharma report.

Adare Pharma Solutions has acquired Frontida BioPharm, a CDMO focused on oral formulations. See press release.

Korean API CDMO ST Pharm has announced plans to build a second oligonucleotide manufacturing plant citing the rapidly growing oligonucleotide therapeutics market. See statement.

ANI Pharmaceuticals has completed the acquisition of New Jersey-based CDMO Novitium Pharma. See press releases.