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High-concentration Protein Formulations

As biomedicine advances and market demands evolve, high-concentration protein formulations (HCPF) are gaining increasing prominence in the biopharmaceutical industry. However, developing these formulations presents several challenges. Drawing on extensive experience in biologics development, ProBio has created a specialized platform that optimizes and accelerates the development process.

Features

- Integrated expertise in viscosity reduction, formulation optimization, membrane selection, and pH drift mitigation, with drug-saving dead volume control
- The most advanced project has got IND approval
- Achieved concentration up to 150 mg/mL
- Expertise in mAb, bsAb, TsAb, and Fc fusion modalities
- Expertise in subcutaneous (SC), intravenous (IV), and intravitreal (IVT) routes of administration

Challenges and solutions in HCPF development

Challenges	High viscosity	High aggregation rate/Degradation of polysorbate	Long reconstitution time
Solutions	Select viscosity reducer Choose appropriate concentration	Early risk identification Perform formulation screening Choose appropriate concentration Develop lyophilization form	Application of crystal excipients Optimization of pre-freezing process Optimization of reconstitution method Choose appropriate concentration
Challenges	Pressure-drop limitation	pH and excipient drift	Sensitivity to loss when FF
Solutions	Select the appropriate UF membrane package Strictly control the process flow Adopt SPTFF process	Offset correction for buffer exchange Adjustment correction after buffer exchange Adjust formulation composition	Drug-saving dead volume control

High-concentration Protein Formulations

Features

Custom Solutions for Critical Challenges

Proven Success Across Modalities

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