PHARMA SPECIAL
Davuluri. Modules 3 and 4 form part of a phased expansion strategy aligned with customer programmes and future demand.
“ We have been active in peptides for 20 years but could only previously produce at tens of kilos scales for acute therapies. GLP-1s changed the equation completely and we decided we wanted to be active in large-volume, commercial scale manufacturing, not just for GLP-1s, but across other therapeutics too,” Davuluri said.
The key to success in APIs, in his view, is being at the convergence of GMP execution combined with deep process chemistry through capabilities like Quality by Design and Design of Experiments that enable the company to file New Drug Applications. Neuland is also active in small molecule synthesis and is looking at building a presence in North America.
Shortly before CPHI, SK Pharmteco announced that it will spend over $ 200 million to expand and upgrade its development and manufacturing infrastructure for small molecules and peptides at Rancho Cordova, California, over five years. It will make targeted investments across key technology platforms, including:
• Development laboratories to accelerate early- through late-stage development for small molecules and peptides
• GMP kilo-scale capacity for peptide purification, which should become available in late 2026, alongside advanced liquid chromatography capabilities
• New manufacturing suites and updated GMP capacity for small molecule APIs
The company added that this complements and continues other recent investments in growth. These included $ 6 million in peptide development at Rancho Cordova, large-scale small molecules and ultrahigh potency APIs( HPAPIs) at Swords, Ireland; and $ 260 million to expand global small molecule and peptide production in South Korea.
Growing into ADCs
ADCs are growing even faster than peptides, albeit from a much lower base. Grand View put the market at $ 14.5 billion in 2025 and projects that it will have a CAGR of 11.5 % from 2026 to 2033 to reach $ 32.1 billion. Many CDMOs are investing in ADC capabilities, some of them extending into linkers from a base in HPAPIs, and four made relevant announcements at or shortly before CPHI.
Axplora, which has been active in ADCs for over 20 years and is in the supply chain for six of the 15 approved ADCs, has completed the first R & D batches of Axotecan, its project to establish an independent European
Workforce outside the first module of Neuland’ s commercial-scale peptides plant source of exatecan for ADCs. This is connected directly to its downstream payload-linker and ADC capabilities.
Exatecan is a highly potent topoisomerase I inhibitor and a starting point for some of the most potent payloads. Access to material at the required quality, scale and time has become challenging due to high demand. Validation batches are targeted before the end of 2026, with registration activities in 2027 and initial GMP supply in late 2027.
Arul Ramadurai, chief commercial officer, said that Axplora has a threepronged strategy: ADCs; small molecules, where it has differentiated technologies in hazardous and energetic chemistries for HPAPIs; and purification, which it supplies for GLP-1s and complex products. All three have enjoyed strong growth, with eight molecules to which Axplora has contributed coming to market in recent years and maybe 12 more in the next 12-24 months.
The company has invested about € 50 million in HPAPIs at Le Mans, France, and Gropello Cairoli, Italy, and a new workshop at Leverkusen, Germany.“ The philosophy behind them is typically based on customer intent,” Ramadurai said.“ We are pushing hard on the need to get to know and understand customer requirements. We are not the biggest CDMO but we can be the one that understands its customers best.”
Further ADC expansion
Meanwhile, Italy’ s Olon expects to open a development centre combining ADC and mammalian cell development at Saint-Julien in France by the end of 2026. Further investments in ADC capacity will follow in early 2027. Saint-Julien is also“ strengthening its links” with the site in Rodano, Italy, where it develops payloads, the company stated.
Sterling Pharma Solutions has just completed a large-scale GMP suite at its bioconjugation facility in Deeside, UK, doubling capacity. This includes a 500L reactor and a 130
m 2
, Grade C cleanroom. It will use
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