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Biologics CDMO

Key Features

Industry-leading Timeline

  • 10 weeks from gene synthesis to Top 6 clones
  • 14 weeks from gene synthesis to Top 1 clone

Excellent Deliverables

  • Antibody average titer 6 g/L, up to 15 g/L
  • 70% of antibodies exceed 5 g/L
  • 60-90 generation stability study

Experienced in Protein/bsAb

  • bsAb average titer 6.7 g/L, up to 10 g/L
  • Protein average titer 4.6 g/L, up to 14.5 g/L
  • Extensive experience in multiple formats
  • ProBox™ CLD solution database

As of June 2024

Service Packages

PreCLD ProCLD ProCLD plus
Service package
  • Cell pool development
  • Developability assessment (optional)

    Case study：Developability assessment

    Cell pool and developability assessment help to identify the potential developability risk and help to select the CMC candidates

    Cell pool evaluation

    Candidates Cell pool Titer /mg/L
    A Middle
    B Middle 
    C High

    Developability: Candidate C was chosen and finally succeed in CMC.

    Stability  Analytical methods Changes from Tday0 and Tend
    Candidate A Candidate B Candidate C
    Free-thawn Appereance Remain the same Remain the same Remain the same
    Stressful (40℃ & 2 weeks) Appereance Remain the same Remain the same Remain the same
    CE-SDS-NR Decrease ca.10% Remain the same Remain the same
    SEC-HPLC Remain the same Remain the same Remain the same
    PTM by MS ~ 10% deamidation (not CDR) ~ 10% deamidation (not CDR) ~ 5% Oxidation (not CDR)
    cIEF Acidic and basic increased Main peak changed Acidic and basic increased
    Bioactivity Remain the same Remain the same Remain the same
    　Acidic condtion (pH3.5 & 25°C  & 4h)  Appereance Remain the same slight suspension slight suspension
    SEC-HPLC Decreased ca. 70% Decrease ca.40% Decrease ca.5%
    PTM by MS ~ 10% deamidation (not CDR) ~ 20% Oxidation (CDR) Remain the same
    cIEF Remain the same Main peak changed Remain the same
    Bioactivity Remain the same Decreased Remain the same
  • Cell line development
  • Top 6 clones
  • PCB & PCB stability
  • Cell line development
  • Feed & medium selection
  • Ambr15 bioreactor performance evaluation
Timeline 7 weeks 10 weeks 14 weeks
Application scenario Late discovery stage, after humanized candidates Preclinical CMC development Preclinical CMC development

Host Cell Commercial License

ProBio also offers cell line platform license to pharma & biotech customers for regulatory filing and biomanufacturing of human and animal drugs. Our cell line platform contains ECACC authorized wild-type CHOK1-GenS, proprietary FUT8 KO cell CHOK1-ADCC+, and a proprietary vector. Benefit from our user-friendly license mode for building your own CLD platform.

  • Lum-sum payment
  • Royalty-free
  • No clinical & product launch milestone payment
  • Incentives for GMP manufacturing in ProBio

Resource

Related Services

  • Contact us
  • Phone: 1-877-436-7274 (Toll-Free); 1-732-885-9188
  • Fax: 1-732-210-0262