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Service Range

Preclinical Phase

- Developability Study
- Cell Line Development
- Process Development
- Formulation Development
- Analytical Method Development
- Pilot-scale Production
- Quality Studies
- IND Filing

Clinical Phase

- Technology Transfer
- Process Optimization
- Process Characterization (PC)
- Process Performance Qualification (PPQ)
- BLA Filing

Commercial Manufacturing

- Drug Substance
- Drug Product

Post-approval Change

- Cost Reduction Strategy
- Change Control Strategy
- Comparability Study
- Regulatory Filing

Bioconjugation

- Bioconjugation Process Development
- Analytical Development
- Formulation and Drug Product Development
- GMP mAb Intermediate and Conjugation Manufacturing
- GMP Drug Product Formulation, Fill and Lyophilization
  • Preclinical Phase

    - Developability Study
    - Cell Line Development
    - Process Development
    - Analytical Method Development
    - Pilot-scale Production
    - Quality Studies
    - IND Filing
  • Clinical Phase

    - Technology Transfer
    - Process Optimization
    - Process Characterization (PC)
    - Process Performance Qualification (PPQ)
    - BLA Filing
  • Commercial Manufacturing

    - Drug Substance
    - Drug Product
  • Post-approval Change Phase

    - Cost Reduction Strategy
    - Change Control Strategy
    - Comparability Study
    - Regulatory Filing
  • Bioconjugation Services

    - Bioconjugation Process Development
    - Analytical Development
    - Formulation and Drug Product Development
    - GMP mAb Intermediate and Conjugation Manufacturing
    - GMP Drug Product Formulation, Fill and Lyophilization
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