Services

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

Nano DSC and typical data

DLS and typical data

Visual inspect

MFI

A Representative Work in Formulation Development

Forced Degradation : • Thermal Stress
• Freeze-thaw
• Light Stress
• Mixing
• Agitation
• Oxidation
Comprehensive Analysis: • Nano DSC: T_m
• DLS: Radius, k_D, T_agg
• 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