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


siRNA Formulation Development

  • Formulation Development: • Well established formulation screening platform for siRNA

    • Experienced in formulating siRNA at high concentration with well controlled viscosity, osmolarity and pH

    • Capable of achieving concentrations up to 200 mg/mL, with viscosity below 6 cP

    • Rigorous assessment of API COA to ensure batch consistency

    • Optimized pH titration and dilution processes for batch consistency

  • Stability Study: • Conduct comprehensive stability studies including:

    - Temperature stress tests: 40°C, 25°C, freeze-thaw cycles.

    - Mechanical stress tests: agitation.

    - Environmental stress tests: light exposure.

    - Degradation studies: long-term, accelerated, and forced degradation.

    • Conduct container compatibility and clinical in-use studies

siRNA Fill & Finish

  • Solution Preparation: • Solution preparation conducted in biosafety cabinets (BSC) and isolator

    • Utilize multiple operation techniques to enhance dissolution efficiency

    • Extensive experience in titration to control pH of siRNA solution

  • Fill & Finish: • Achieved higher DP yield from lower than industry filling line loss (< 100mL), resulting in significant cost savings for clients

    • Experienced in fill & finish of high viscosity and high concentration formulated products

    • Aseptic fill/finish line (Bosch isolator, 100,000 vials/batch, 0.4 to 35mL fill volume) meeting typical 0.5~1.5 mL filling requirement for RNA drugs, with fill weight accuracy of <5%

    • Completed over 60 DP lots with 100% success rate

siRNA Analytical Capability & Experience

  • Lifecycle Management of QC Method Per ICH/USP/ChP: • Identity: IPRP, AEX, IPRP-ESI-MS, Sequence (MS-MS), Tm (UV), FTIR

    • Assay: Slope spectroscopy (UV)

    • Purity and Impurity: IPRP, AEX

    • Pharmacopeia Method: Appearance, osmolality, visible particles, sub-visible particles, endotoxin, bioburden, sterility, etc.

  • Project Experience: • Analytical method development, optimization, and qualification

    • Drug product specification setting and stability study

    • Impurity characterization and particle identification


HPLC (1260) & UPLC (H-Class)

UPLC-HRMS (Q-Exactive )

UPLC-MS (Bioaccord)

Raman Spectroscopy (HOUND)

Slope Spectroscopy (Solo VPE)

FT-IR (iS5)

Liquid Particle Counter (HIAC 9703+)