Shilpa CDMO, a contract development and manufacturing organization focused on complex small molecules, will launch as a separate brand from parent company Shilpa Medicare at CPHI Milan next month.
The business will be formally unveiled at the CPHI Milan trade event, scheduled for Oct. 6-8 at Fiera Milano. Shilpa CDMO will provide development and commercial manufacturing services to biotechnology and pharmaceutical companies working on complex small-molecule programs.
The company said its areas of work include highly potent active pharmaceutical ingredients, or HPAPIs; peptides; antibody-drug conjugate payloads and linkers; proteolysis-targeting chimeras, known as PROTACs; and oligonucleotides.
Shilpa CDMO said its platform includes 230 kiloliters of reactor capacity, three research and development centers, more than 400 scientists and two dedicated active pharmaceutical ingredient manufacturing sites. Its services extend from discovery and route scouting through process and analytical development to commercial drug-substance and finished-dose manufacturing.
The company said it will also announce commercial-scale peptide-manufacturing capabilities at CPHI Milan. No details were provided on the location, capacity, investment amount, timing or regulatory status of the peptide facilities.
Shilpa CDMO will operate separately from Shilpa Medicare, while drawing on the parent company’s experience in oncology-related chemistry, development and manufacturing. The announcement did not specify whether the new organization will have independent legal ownership, management, financial reporting or manufacturing assets.
The business also cited its relationship with Shilpa Biologicals, which provides antibody production, conjugation and fill-finish services. Shilpa CDMO said its payload and linker chemistry operations are located within 200 miles of Shilpa Biologicals’ facilities, potentially reducing the shipping of intermediates for antibody-drug conjugate and other conjugate programs.
The launch comes as drug developers seek additional manufacturing options for complex molecules, including providers outside China.