Polpharma API Selected by Celon Pharma for ADC Payload-Linker Manufacturing

COMPANY PROFILE
  • Polpharma API has been selected by Celon Pharma to provide GMP development and manufacturing services for a payload-linker compound supporting an antibody-drug conjugate (ADC) development program.
  • The manufactured payload-linker will be used following antibody conjugation in a Phase I clinical trial for a targeted therapy being developed for solid tumors.

Polpharma API has been selected by Celon Pharma to provide development and GMP manufacturing services for a payload-linker compound supporting Celon Pharma’s antibody-drug conjugate (ADC) development program. Celon Pharma is developing the oncology therapy based on its own intellectual property, while Polpharma API will contribute its high-potency manufacturing capabilities and GMP technology platform to support the project.

Under the agreement, Polpharma API will scale up and manufacture the payload-linker compound under GMP conditions. The company said the project expands its high-potency capabilities for advanced oncology modalities and contributes to the development of integrated ADC manufacturing capabilities in Poland. The work also strengthens its CDMO and contract manufacturing offering for high-containment projects.

The payload-linker consists of a linker conjugated with the highly potent payload monomethyl auristatin E (MMAE), requiring specialized infrastructure and controlled handling. According to the company, the project demonstrates its ability to manufacture highly potent compounds for complex production programs.

Following conjugation with a specific monoclonal antibody, the material will be used in a Phase I clinical trial. The therapy is being developed for immunomodulatory and cytotoxic effects in the treatment of solid tumors.

Polpharma API said the collaboration supports Celon Pharma’s targeted oncology development program while expanding its capabilities in HPAPI and ADC-related manufacturing.

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