New GMP suite at Sterling’ s site in Deeside
both flexible and hard containment technologies to handle highly potent compounds. Sterling has also added a 315 m 2 analytical development laboratory at the site.
Finally, Lonza has acquired an exclusive licence agreement to Qurient’ s cyclin-dependent kinase 7( CDK7) inhibitors for dual-payload ADCs. This gives the company access to SYN-duo CC, a new dual-payload that combines a topoisomerase 1 inhibitor, a camptothecin derivative and a specific CDK7 inhibitor. It can also use its existing proprietary platform to derive additional, novel combinations with any other payload.
Lonza, said Jason Bertola, executive director of commercial development for North America, has the largest commercial market share in ADC services. Although there has been a lot of investment, the market is still underserved, considering that ADCs account for about 25 % of the global pipeline.
As the largest player in the very fragmented CDMO market, Lonza is often seen as the bellwether of the sector. Business remains very strong, Bertola said, with demand growing in small molecules, and he expects this to continue well into the foreseeable future.
In late October, Lonza further announced that it will be converting existing mid-scale bioconjugation manufacturing suites for into a standardised single-use platform by 2027, in addition to the large-scale commercial capacity that is expected to be operational from 2028. The stated aim is to“ offer customers a scalable manufacturing pathway from clinical development through commercial supply for ADCs and other bioconjugates.”
In early November, a further major deal confirmed Lonza ' s focus on complex modalities and a US presence( see page 7). The company acquired the US CDMO business of Merck KGaA, adding five more sites active in areas including conjugates, payload linkers and viral vectors, bringing its total in the US to nine.
Oligos also growing
Closely related to peptides, oligonucleotides form another modality growing rapidly from a low base. Grand View project the global oligonucleotide therapeutics market is projected to grow from $ 8.6 billion in 2026 to $ 29.6 billion by 2033, with a CAGR of 19.4 %.
Key recent developments include PharmaBlock opening its Oligonucleotide, Peptide and Conjugates( OPC) R & D centre in the Nanjing Jiangbei New Area, China. The 7,000 m 2 facility features an‘ intelligent lyophilisation’ platform and OEB 5 laboratories for safe handling and process development of highly potent compounds.
Agilent Technologies revealed at CPHI that it has added further laboratory space at in Boulder, Colorado, to support the development and scale-up of emerging technologies for oligonucleotide therapeutics. The initial focus is on enzymatic ligation, which is seen as a complement to established solidphase phosphoramidite synthesis. Initial programmes were expected to begin in November.
Oligonucleotides have become a key growth driver for one major European CDMO, EuroAPI. The company is also strong in fermentation after repurposing some columns it inherited from Sanofi that had been used to make Vitamin B 12 and which were no longer viable in a market that has almost entirely moved to China.
“ We don’ t want to get into GLP-1s,” said Nicolas Giel, general manager in North America.“ China has created whole cities around them. We offer something different: a European presence in niche, added-value areas like oligos, where we can offer large-scale manufacturing.” For this reason, EuroAPI’ s sweet spot is with large biotechs at Phase II-III who are preparing to ramp up production.
EuroAPI has emerged from some difficult years when it did not make up for the loss of Sanofi legacy business with CDMO business as rapidly as it had planned, among other things. It is now enjoying strong growth on the back of demand for European supply, Giel said.
Let us spray
Just before CPHI, Lonza also revealed that it had broken ground on a new commercial-scale, PSD- 4 spray-drying facility at Bend, Oregon, supporting large scale
16 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981