抗体药物偶联 (ADC) 技术使用单克隆抗体（mAb）将有效的高活性药物成分（HPAPI）递送至靶细胞。偶联形式下的HPAPI会表现出选择性的细胞毒性，可使非靶细胞免受毒性影响。
Starting with an initial cell line, a scalable process template is developed to produce cGMP batches of the monoclonal antibody (mAb).
A highly active payload and drug-linker are matched with the mAb for eventual conjugation into an antibody drug.
Monodisperse and activated PEGs, or Chetosensar™ technology may solve solubility challenges during drug discovery and development. Advanced payload intermediates for the most common classes of payloads can help to reduce development timelines.
The developed components of cell line, antibody, payload, and linker come together during conjugation and/or bioconjugation.
BDS as well as final drug product receive extensive analytical testing, including stability and release testing.
Linkage between the antibody and a highly active payload is a critical component of an ADC, requiring a broad range of products and chemicals.
An optional chromatographic step can be used to remove high molecular weight species such as antibody aggregates and free drug residuals, while supporting optimization of drug-antibody-ratio (DAR) and control of polydispersity.
The Eshmuno® CMX resin has been designed for highly selective mixed mode chromatography.
Removing residual solvent and free drug after conjugation is necessary prior to preparation of the final formulation with the desired concentration and buffer.
The Pellicon® Capsule is the first of its kind–a true single-use TFF device that comes ready to process ADCs in minutes.
Sterilizing-grade filtration is under increasingly intense scrutiny by regulatory bodies, requiring a high degree of sterility assurance.
The BDS is prepared for a final and unique formulation. The lyophilized dosage form is preferred and usually contains a buffer, stabilizer (e.g, trehalose or sucrose), and surfactant.