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Services | HJB - Your Trusted Biologics CDMO Partner

HJB - Your Trusted Biologics CDMO Partner

HJB, CDMO, biologics, HJB Bio, hjbbio, China CDMO, 杭州奕安济世, Just Bio, Just biotherapeutics, HJB bio, HJB China, Hangzhou HJB

HJB - Your Trusted Biologics CDMO Partner

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Formulation and Process Development

We offer integrated and systematic formulation and process development services focusing on monoclonal antibodies, Antibody Drug Conjugate (ADC), fusion proteins, blood factors and bispecific antibodies. Quality by design approach will be used to quickly choose the appropriate formulation, and a series of researches will be performed to meet the preferential timeline for IND filing.

Main Services

• Preformulation screening, consist of pH, excipient and surfactant screening

• Formulation development and optimization

• Design of Experiment (DOE) to identify optimal formulation and CQAs

• Forced degradation studies to identify degradation pathways

• Primary Container compatibility

• Clinical in use stability study including dilution effect and compatibility with injection kit

• Fill and finish support to Tox run production

• CMC dossier for IND filing

A representative work in formulation development

  • Forced degradation : • Thermal Stress

    • Freeze-thaw

    • Light Stress

    • Mixing

    • Agitation

    • Oxidation

  • Comprehensive Analysis: • Nano DSC: Tm

    • DLS: Radius, kD, Tagg

    • Size purity: SEC, CE-SDS(NR&R)

    • Charge heterogeneity: CEX, cIEF, PTM

  • Particle Control: • Visual inspect in RTU vials for visible particles

    • MFI: Count and characterization for sub-visible particles

    • Biosafety cabinet available in grade D pilot plant.

  • QbD and DOE design: • QbD and DOE by JMP are used to do formulation optimization, identify CQA, robustness analysis and risk management

Devices

DLS

Nano DSC

MFI

mVROC

Dosing pump

Stability Chamber 110L

Stability Chamber 400L

Mixer

SERVICES