Formulation_Hangzhou Healsun Biopharm Co.,Ltd.

Upstream Media Customization Downstream Formulation

Formulation Process Development

Extensive R&D experience in mAbs, bsAbs, fusion proteins, ADCs, and other liquid & lyophilized powder formulations.

Provides robust formulations and scalable processes to meet the formulation and process development requirements of various biopharmaceutical products.

Development and optimization of high-concentration formulations and lyophilized formulations
Stability studies: stress test (High temperature, Light exposure, Repeated freeze-thaw cycles, Agitation/shaking), as well as accelerated and long-term stability studies
Evaluation of the suitability and sealing integrity of packaging materials
Compatibility stability studies based on ICH guidelines and pharmacopoeial standards of different countries
Studies on sterilization processes
Studies on freeze-thaw, mixing, and pump shear forces
Process characterization by scale-down model

Upstream Media Customization Downstream Formulation

Formulation Process Development

Main Equipment

Early-Stage

CMC Process

GMP Pilot Production

Commercial Production

CGT

Biosimilars

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