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Novasep Finorga sell "CDMO services for ADC payloads"

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Basic Information

524
31
12
3.7(36)

Trade Type

Sell

Service Name

CDMO services for ADC payloads

Specifications

  • Application: End-to-end ADC (antibody-drug conjugate) payload manufacturing from process development through cGMP production
  • Certification Standard: cGMP-compliant ADC payload manufacturing
  • Regulatory Status: Supports process/analytical development, characterization, and design-of-experiments (DoE) studies under cGMP

Other Information

Additional Description:

Novasep provides end-to-end ADC payload manufacturing, from process development through cGMP production. Services span R&D lab work, analytical and process transfer/familiarization, process and analytical development, process characterization, and design-of-experiments studies at batch sizes up to 10 g; kilolab-scale cGMP production for clinical trials, process validation, and cGMP commercial supply up to 500 g batches; large-scale cGMP production for clinical trials, process validation, and commercial supply up to 1 kg batches; and quality control covering method development, transfer and validation, in-process control, release testing, and stability studies.
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