Pfizer CentreOne supports ADC conjugation as part of an end-to-end bioconjugation workflow, integrated with upstream antibody production and downstream purification, formulation, and testing. Our teams have experience with a wide range of cytotoxic payloads and linkers, and deliver ADC assembly, supported by in-house small molecule chemistry and purification infrastructure.  

At our North Creek site, fully single-use conjugation environments support high-potency and non-high-potency modalities, as well as traditional cytotoxic ADCs and emerging conjugate formats. Across our ADC manufacturing network, drug–antibody ratio (DAR) control and batch-to-batch consistency are supported through cGMP-compliant processes, in-house QC, and MSAT and pilot-scale capabilities for clinical-to-commercial scale-up. 

We embed safety into every aspect of our ADC services and facilities. Our North Creek, WA, and Pearl River, NY, sites provide dedicated spaces for highly potent and cytotoxic drug processing, with controlled environments purpose-built for safe and efficient handling of complex ADC compounds.  

The entire product flow path is single-use, reducing cross-contamination risk and supporting rapid changeover between programs. In-house QC labs provide in-process, release, and stability testing to maintain rigorous safety and quality standards throughout production. 

Yes. Our antibody–drug conjugate manufacturing facilities operate under current Good Manufacturing Practice (cGMP) standards and undergo routine inspections by global regulatory authorities. Inspection experience includes FDA, EMA, PMDA, MHRA, Health Canada, ANVISA, NMPA, TGA, Korean FDA, GCC / GCC-DR, AIFA, COFEPRIS, Turkish MoH, Taiwanese MoH, EAEU, MOITRF, Kazakhstan, and Belarus. 

Our regulatory team is well-equipped to support submissions to health authorities worldwide. Download our regulatory support brochure to learn more.