6. Sterile Formulation Plant

Brief Introduction

Specialized formulations involve high technical barriers and fewer competitors, offering lower risk compared to new drug development—making them an ideal entry point for Taiwan’s biopharmaceutical industry.

The ITRI Sterile Formulation Plant possesses extensive experience in advanced drug formulation development, providing services for small-molecule, nucleic acid, and protein-based drugs. Offerings include formulation design, analytical method development, process scale-up, and customized production line design.

These capabilities help accelerate preclinical and commercial development of new dosage forms and enhance pharmaceutical industry competitiveness.

Scope of Services

1. Formulation Development

Support companies in using Design of Experiments (DOE) to identify critical manufacturing parameters and develop optimal formulations.

2. Scale-up and Analytical Method Development

˙Polymer microsphere process scale-up

˙Nanoliposome process scale-up

˙Aseptic liquid formulation scale-up

˙Optimization of lyophilization (freeze-drying) processes

Core Facilities

1.  Process Equipment

   1. Microsphere production system

   2. High-pressure homogenizer

   3. In-line homogenizer

   4. Spray dryer

   5. Isolator glovebox

   6. Automatic and benchtop filling machines

   7. Freeze dryer

2. Analytical Instruments

   1. High-performance chromatography systems (LC-UV, VIS, ELSD, GC)

   2. Microparticle and nanoparticle size analyzers

   3. Spray particle size analyzer

   4. Differential scanning calorimeter (DSC)

   5. Viscosity analyzer

   6. Osmometer

   7. In vitro dissolution testers (USP Apparatus 1, 2, and 4)

Info

• 鄭平福 博士

• +886-3-5743908

• rseq@itri.org.tw

• 羅友文 博士

• +886-3-5743976

• itri950682@itri.org.tw