Process Development

Our process development service employs a phase-appropriate approach that provides quality by design. Our Service uses structured process development to deliver exceptional results across a broad range of projects, leveraging design-of-experiment techniques in JMP and comprehensive in-house analytical capabilities.

Top Productivity & Quality Modulation

Our team of upstream development experts specializes in thorough media and additive screening for optimal cell culture processes. We integrate extensive libraries and optimize screening processes through parameters.

Titer Enhancement Platforms

  • • An intensified cell culture platform that improves productivity by increasing the initial cell density (ICD) of a main culture through N-1 perfusion

Quality Modulation Platforms

  • • A modular glycosylation platform to optimize glycosylation regarding ADCC and CDC functions through the Design-of-Experiment investigation
  • • A precise charge variant modulation platform achieved through a thorough screening process
    • Optimization of media, additives and process parameters (ICD, pH, shifted temperature, feeding rate)

Refined Expertise and Streamlined Optimization

We utilize a robust downstream purification strategy and a diverse resin library to meet a wide range of purification needs,
ensuring flexibility with our efficient screening approach.

Purity and Yield Improvement Through DoE

Our rigorous procedures have consistently resulted in maintaining or improving both yield and purity based on our project experiences.

Formulation and Drug Product Expertise

Drawing on their extensive experience, our team of experts in the DP/Formulation Development Group is dedicated to optimizing formulations to enhance product stability and efficacy.

  • Surfactant
    Screening

  • pH/Buffer
    Screening

  • UF Feasibility
    Study

  • Excipient
    Screening

  • Determination of
    Final Formulation

High Concentration Formulation Platform

Samsung Biologics' formulation platform maximizes drug delivery and stability through high concentration.

  • • Stable liquid formulation for 150 mg/mL SC injection
    • Achieved viscosity of less than 7 cP

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