Porton Delivers Dual-Payload ADC IND, Advancing Next-generation Conjugate Drug Development

Dual-payload ADCs, leveraging a dual-mechanism cytotoxic effect, have emerged as a core strategic direction for next-generation antibody-drug conjugates. However, significant industrialization barriers remain in terms of conjugation homogeneity, dual-toxin compatibility, and process scale-up, imposing stringent demands on CDMOs' end-to-end CMC capabilities. Recently, Porton One-stop Biologics and Conjugates CDMO Platform successfully completed the full-cycle delivery of process development and GMP IND clinical sample manufacturing for a dual-payload ADC. The scope encompassed all critical components, including payload-linker, antibody, and ADC R&D and manufacturing, and achieved seamless execution from process development through to regulatory lot release.
This milestone comprehensively validates the maturity and robustness of Porton’s platform for biologics and conjugate-based therapeutics.

Technical Innovation Meets Seamless Integration

The successful IND delivery of this dual-payload ADC underscores the technical strength of Porton‘s platform in tackling complex conjugate drugs.

1）Throughout the project, the team cracked key challenges such as site-specific conjugation of two distinct payloads and fine-tuned control over payload stoichiometry. A robust and reproducible manufacturing process was established, and pilot-scale production was successfully achieved.

2）Backed by our co-located and integrated service platform, cross-module collaboration ran smoothly and efficiently. Process development and GMP manufacturing of the payload-linker were proactively aligned with downstream conjugation requirements, with quality attribute considerations for downstream steps incorporated at the process design stage. This enabled seamless integration of antibody production with small-molecule conjugation, creating a fully coordinated workflow from R&D through manufacturing to eventual application, translating into faster timelines and greater process robustness.

Huifang Dong, Ph.D

Head of Porton Large Molecule Platform

“We have been building our capabilities in next-generation conjugation technologies, including multi-payload and bispecific ADCs. Through ongoing process optimization and dedicated capacity expansions, we are building a service framework that spans early-stage development through commercial manufacturing. Our platform has developed strong capabilities in payload-linker R&D and manufacturing, antibody pilot-scale production, and dual-payload ADC process development, forming differentiated competitive advantages.”

One-stop Platform for End-to-end CMC Services

Through sustained investment and accumulated technical expertise in biologics and conjugates drug development, Porton has established four integrated R&D and manufacturing sites across Shanghai, China (Minhang, Fengxian, Pudong) and New Jersey, USA. These facilities cover the full spectrum from drug substance to drug product, and from early development through to commercial manufacturing, offering a unified CMC service platform for both single- and dual-payload ADCs. This creates a closed-loop technology matrix with comprehensive in-house capabilities. The platform has built an extensive track record in integrated R&D and manufacturing projects covering ADCs, AOC-type drugs, payload-linkers, and oligonucleotides, with end-to-end service capacity across multiple conjugate drug modalities.

Today, Porton Biologics and Conjugates Platform offers comprehensive CMC solutions spanning peptides and oligonucleotides, payload-linker synthesis, conjugate drug developability studies, cell line development, upstream and downstream process development, conjugation process development, formulation development, analytical method development, drug substance and drug product GMP manufacturing, stability studies, clinical trial material production, and regulatory CMC documentation compliant with global drug registration standards.

As the global pipeline of dual-payload ADCs continues to expand and market demand steadily grows, Porton remains committed to strengthening its antibody andADC capabilities. Leveraging its proven track record and standardized technical frameworks, Porton aims to reduce CMC-related development risks for its clients and shorten clinical translation timelines. Porton enables innovative biopharma and biotech companies worldwide to accelerate their drug candidates into the clinical phase, advancing the mission of enabling earlier access to good medicines.