Biologics & ADC Fill and Finish Manufacturing

Biologics & ADC Fill and Finish Manufacturing

MabPlex offers complete services from formulation to packaging of monoclonal antibody and ADC products in compliance with GMP requirements. We provide full services for a broad range of biologics and ADC drugs manufacturing from preclinical to commercial production.Our production lines feature a range of advanced equipment in order to satisfy various customer requirements. We also will assist you in developing an optimal process design.

GMP manufacturing capabilities

  • Formulation, lyophilization and fill/finish for monoclonal antibodies
  • Formulation, lyophilization and fill/finish for antibody drug conjugations
  • Formulation, lyophilization and fill/finish for fusion proteins
  • Final product packaging
  • Complete product characterization analysis, formulation evaluation, and lyophilization processes with complete GMP batch records and related documents
  • Lyophilization, fill/finish, and packaging services in compliance with GMP standards
  • Complete batch records and related documents in accordance with GMP requirements for clients’ future needs
  • Each batch is released under comprehensive quality management system control

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