traditional chemistry, such as antibody-drug conjugates( ADCs), monoclonal antibodies( mAbs), RNA-based therapies, PROTACs, oral peptides and tri-specifics, which are all part of the drive towards personalised medicine
A base in the US
In the current geopolitical situation, a US base is an obvious advantage for a CDMO. One such is Evonik, which, despite being headquartered in Germany, has 80 % of its contract manufacturing capacity in the US. It also claims to have the best regulatory history in the industry, with no observations in eight consecutive FDA inspections.
As a result,“ we have a lot of enquiries and exciting opportunities – a lot of people want to talk to us,” said Theresa Ledbetter, segment head for key accounts.“ A lot of customers globally are looking at nearshoring or onshoring and regional supply. That’ s where we come in, as we have the footprint for manufacturing and a global supply chain.”
Despite all the talk about new modalities, Ledbetter added, small molecules have not gone away. High potency and speciality containment and handling remain in strong demand too, while, as
Cambrex will add 40 % more capacity at Charles City many others observed, the pressure for sustainability and compliance will never go away.
In the week before CPHI Frankfurt, Cambrex announced a $ 120 million investment to expand its US operations, addressing increased demand for API development and manufacturing there. This includes a 40 % capacity increase at the largescale facility in Charles City, Iowa, from 700,000 to about 1 million L, on the same platform as previous expansions in 2018 and 2022.
“ Tariffs are part of it but this has been going on since COVID, when people became concerned about their supply chains,” said chief scientific officer Dr Matt Bio.“ I think we’ ve seen more action in the last nine months than we had previously. People are signing contracts and starting to think strategically about how they are going to position themselves regionally: US manufacturing for US sale, European manufacturing for European sale.”
There will also be five to six new 16,000 L work centres at Charles City, bringing the total to up to 19, plus large-scale peptide manufacturing. Cambrex has developed some liquid-phase peptide synthesis in recent years, enabling it to apply its 1.4 million L / year of small molecule capacity to make peptides.
The company already has more than ten programmes in development, including some moving towards launch. Whilst 60-70 % of this is for obesity and diabetes, Bio noted that work in discovery when addressing these targets has generated learning about managing the metabolism, dosing and half-life of peptides, opening up indications in areas like oncology and PMSA that were previously only druggable with mAbs or ADCs.
Global network bonus
Sterling Pharma Solutions has made two key recent investments: a second GMP suite for ADCs at Deeside, UK, and an ultra-high potency suite at Germantown, Wisconsin. The company is also looking at installing additional development capacity at Germantown to meet the onshoring trend.
“ We’ ve been seeing this for several years now, either for second-sourcing in the US or reputational reasons,” said chief scientific officer Dr Matt Minardi.“ A lot of companies still do that first tox batch in Asia but want to do GMP manufacture in the US.” Geopolitical factors have further pushed this but the biotechs were doing this already.
Sterling has also pushed – and trademarked – the‘ Extended Bench’ model, which it sees as an evolution of the FTE model in which it delivers scientific services via a single project manager to accelerate the path to market utilising its whole network to offer, say, parallel syntheses in different time zones. This gives the company the flexibility to adapt to changing business dynamics, it is claimed.
Leveraging a global presence enables Sterling to“ have a nice tariff play” on some projects, such as when bringing in starting materials from China to the UK for chemical transformation before bringing them into the US. The company also has a large ex-Novartis facility in Ireland for additional flexibility and security.
12 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981