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Downstream Process
Development

The downstream process development team of Thousand Oaks Biologics has rich experience in the development of various biological therapy drugs, including monoclonal antibodies, bispecific antibodies, Fc fusion proteins, fusion proteins, antibody fragments, enzymes, and recombinant adenovirus vaccines. We provide the development of classic mAb downstream processes, non-antibody downstream processes, and ADC conjugation processes (based on cysteine and lysine non-targeted conjugation and transpeptidase-targeted conjugation), supporting the development of biological drugs CMC at different stages from preclinical, early clinical (I/II), critical clinical (III), process characterization, and process validation.

We are equipped with well-known global brands of chromatography and equipment, ultrafiltration equipment, and detection instruments, including AKTA Avant, AKTA Pure, AKTA Pilot, AKTA process, AKTA flux, Solo VPE, Nano drop, UV1900 and other advanced analyzers, supporting the development of downstream purification processes in different modes and stages.

The downstream purification process platform provides the following core technical services:

  • Early-phase downstream purification process development
  • Downstream purification process technology transfer and scale-up
  • Process optimization for improved yield or product quality
  • Commercial downstream purification process development, characterization, and validation
  • Scale-down model-based validation studies (e.g., viral removal/inactivation validation, impurity clearance validation)
  • Regulatory submission support and documentation preparation