Speciality Chemicals Magazine MAY / JUN 2025 | Article Title

PHARMACEUTICALS

Another Indian firm, Neuland , has announced a $30 million investment in a multi-product, multi-modular peptide facility at Hyderabad. Neuland is seeing growing demand in every phase right up to commercial manufacture, said Dr Nicola Giubellini, head of CMS business development in Europe, and this will enable it both to meet that demand and serve innovators as well as complex generics formulators.

The company subsequently opened a new laboratory at another site in Shanghai for highly potent compound synthesis at hundred-gram scale. Operating within occupational exposure band (OEB) 5 and up to 100-gram scale, this is designed to accelerate discovery and early development programmes for conjugated drugs of all kinds.

signed a $150 million agreement with Viking Therapeutics to make a dual GLP-1/GIP receptor agonist peptide API at tonne quantities, plus 200 million vials and 1 billion tablets for its subcutaneous and oral peptide formulations respectively.

Key facilities will include DCS automation, isolation and purification, LPPS and SPPS synthesis capacity of 6,400 L, and the ability to handle OEB 5 compounds. The first modules will come onstream in 2H 2026 and will make peptides at tens of kg scale, ramping up to hundreds of kilos when the others are ready.

“This is where we also want to continue focusing, providing fully integrated services to customers and adding value,” said Quirmbach. Small molecules should not be overlooked either. High potency has been a key growth area for CordenPharma and it is also getting a lot of inquires for oligonucleotides. The company signed contracts worth €4 billion in 2024.

All this essentially gives the company the ability to carry out peptide development at all scales. Projects ultimately transition to the OSD facility at Irvine, California, for commercial manufacture. BioDuro has about 1,500 active customers, noted chief marketing officer Kevin Li, 65% of them and rising in the US, and new modalities are the key growth drivers.

ADC expansion

Piramal Pharma Solutions invested $45 million in ADCs at its site in Grangemouth, Scotland, in 2023 and is now investing another $90 million in two other sites to support its integrated ADC offering. The company’s sterile fill-finish site in Lexington, Kentucky is adding commercialscale capabilities, while the Riverview, Michigan site is expanding its commercial offering in payload-linkers. These three sites – along with Piramal’s affiliate Yapan Bio, which supplies mAbs – work together to deliver integrated ADC services on an accelerated timeline under the branded program known as ADCelerate.

In January, BioDuro opened a kiloscale , SPPS scale-up laboratory at Shanghai to complement its peptide R&D facility in Beijing. Key features include automated synthesisers, cleavage systems and freeze-drying equipment, supporting scale-up to 800 mmol. It is designed to produce a wide range of peptide molecules, including linear and cyclic peptides and conjugates.

Indians into peptides too

During DCAT Week 2025, Shilpa Medicare launched a full-service ‘hybrid’ CDMO model. This will combine discovery, clinical and commercial outsourcing services for small and large molecules and peptides, including GLP-1s, with commercially ready novel formulations for exclusive licensing.

At DCAT Week, Jim Li, president of global CMC solutions, announced the building of another site at Bengbu, China, for opening in September. This will have six pilot- and two-commercial scale reactors at scales of 500-15,000 L for non-GMP registered starting materials (RSMs) and advanced intermediates, for a total of 130,000 L.

Shilpa spans LPPS and SPPS and combinations of both, with peptide API capacity of 40 kg/year and 20 million units/year of fill-finish services for cartridges and devices. There are also 8,000 L of mAb capacity that can be doubled when a 200,000 L microbial fermentation facility becomes operational later this year.

“They are working with good synergy on ten to 15 projects a year,” said Jean- Francois Carniaux, global API technical lead. He added that a “big shift in the paradigm of ADCs” taking place. In recent months, projects have been coming in requiring a ligand rather than a linker, making the product a modified mAb. Piramal is well placed to profit from this trend.

Subsequently the Shilpa Biologicals subsidiary signed a partnership with mAbTree Biologics. This covers clinical studies, and longterm commercial supply with GMP manufacturing for a fully human mAb that will act as an immune checkpoint protein in oncology, which is also a particular therapeutic speciality in CDMO services.

“We are all part of the supply chain and to make our capabilities work to deliver drugs to the patient, we need to build deep and lasting partnerships, where both parties are heavily invested in successful outcomes,” Martin Meeson, CEO of Axplora , told DCAT Week delegates.

From its site in Mourenx, France, Axplora offers GMP purification for GLP- 1s. Over $50 million has been invested in “very large” capabilities that Meeson said would be BLA-ready for its key partner in 2026, exemplifying the need for speed in GLP-1 development.

Quirmbach – Initial capacity in peptide facility almost booked out

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