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Formulation
Formulation

Our Formulation Development team offers services to develop customized formulations for different biologics, such as monoclonal antibodies, bi-specific antibodies, single-chain antibodies, nano antibodies, recombinant proteins, and fusion proteins . Key capabilities include filling process and formulation characterization (DoE), molecule developability and high concentration formulations.

Services

Fast-track platform to support biologics’ developability evaluation.

Pre-formulation and formulation to support clone selection, process development and degradation pathways identification.

Rapid buffers and excipients screening by DSC, particle counting and/or spectrometry.

Container/closure selection and integrity test.

Filling process development, including freeze-thawing, dilution and mixing, holding times, filtration, filling rate and so on. Technical transfer and scale-up to support for GMP fill- & finish.

Long-term, accelerated, in-use stability and forced degradation studies will carried out base on the policy from ICH, ChP and so on.

Lyophilization process development.

Typical Formulation Workflow

  • 1~2 weeks

    Developability Study

    Bioworkshops Platform method

    PEG-Induced, AC-SINS(Affinity Capture Self Interaction Nanoparticle Spectroscopy), e.g.

  • 12~24 weeks

    Formulation Development

    Pre-formulation

    Excipient and Surfactant Screen

    Formulation confirmation (3 Months)

    Generate materials for pre-clinical development

    Formulation Development Report

  • 3~4 weeks

    GMP DP Manufacturing

    Fill-Finish

    Inspection & Package

    Storage

    Fully validated aseptic processing

    Media Fill for custom primary packaging if need extra line to balance the text