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Providing innovative and affordable medicines
for all patients
  • 1
    Discovery

    ● mAb Candidate Generation, Screening and Engineering

    – 1.5x1010 phage display

    – Hybridomas

    – Llamas single domain platform

    – Humanisation

    – Affinity maturation

  • 2
    In Vitro and In Vivo Functional Studies

    ● 40+ xenograft mouse tumour models

    ● Two syngeneic mouse tumour models

    ● Human peripheral blood mononuclear cell models

    ● CD34+ cell-humanised mouse models

    ● Covering 16 cancer types

  • 3
    Cell Line Construction

    ● Patented protein expression technology

    ● High-level expression of the integrated transgene

    ● High through-put screening

    ● Master cell bank and working cell bank in compliance with GMP standards and in accordance with ICH Q5A

    ● Advanced single-cell dispensing technology

  • 4
    Upstream Process

    ● Proprietary cell culture media

    ● Cell culture process development with high-titre and high quality

    ● Process characterisation in accordance with ICH guidelines

    ● Perfusion cell culture process development

  • 5
    Downstream Process

    ● Scale up model

    ● Continuous purification technology

    ● Process automation platform

  • 6
    Formulation Development

    ● Formulation and fill/finish process development technology in liquid or lyophilised form

    ● High concentration achieved by physical and chemical stress evaluation system, excipients screening, and analytical methodology

    ● Long-term drug product stability

  • 7
    Structural Characterisation and Quality Study

    ● Primary & higher order structural characterisation

    ● Identification of process- and product-related impurities

    ● Structure-function relationship study

    ● Forced degradation study

    ● CQA determination following ICH Q8

    ● Selection of a panel of release of methods and determination of specifications

    ● Qualification of reference material

    ● Similarity study if the product is a biosimilar

  • 8
    IND Filing
  • 9
    Clinical Development

    ● Conducted or conducting more than 20 trials globally

    ● Closely managing concurrent large-scale, multi-jurisdictional, late-stage trials

    ● Strong familiarity with, and understanding of, regulatory approval pathways across different jurisdictions

  • 10
    NDA Filing
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