BIOPHARMACEUTICAL ENGINEERING · PILOT MANUFACTURING

Biopharmaceutical Engineering Research Laboratory

A pilot-scale environment for developing clinical-grade biopharmaceutical manufacturing processes, connecting controlled fermentation with harvesting, purification, aseptic filling and quality-oriented translation.

01Microbial fermentation

Controlled cultivation capacity up to 500 L for process development at pilot scale.

02Cell-culture fermentation

Cell-culture systems up to 500 L within a Biosafety Level 2 manufacturing environment.

03Downstream and aseptic finish

Harvesting, purification, aseptic filling and finishing connect cultivation to a complete development pathway.

NATIONAL BIOPHARMACEUTICAL FACILITY

Infrastructure for first-in-human manufacturing development.

Located at KMUTT Bang Khun Thian, the National Biopharmaceutical Facility is described by BIOTEC as Thailand’s prime manufacturing facility for clinical-grade biopharmaceuticals intended for first-in-human studies. Its microbial and cell-culture fermentation systems reach 500 L, operate at BSL2, and are supported by harvesting, purification, and aseptic fill-and-finish capabilities.

01Define product and process
02Develop controlled cultivation
03Recover and purify
04Aseptic fill and finish

ENGINEERING CONTINUITY

A facility matters because the process remains connected from culture to finished container.

The pilot plant is designed with international expectations in mind, including USFDA and PIC/S. This does not make every output automatically compliant; it provides an engineering environment in which process controls, documentation and quality decisions can be developed systematically.

UPSTREAM

Microbial systems

Develop inoculum, cultivation conditions, feeding strategy and controllable fermentation parameters before scale-up.

CELL CULTURE

Cell-based production

Translate cell-culture requirements into controlled pilot operations while maintaining biosafety and process consistency.

DOWNSTREAM

Harvest and purification

Separate target material from cells, media and process impurities while balancing recovery, purity and manufacturability.

ASEPTIC OPERATIONS

Fill and finish

Prepare purified material for aseptic filling and finishing under defined controls and traceable operating procedures.

CONNECTED COLLABORATION

Return to the shared research environment.

The two laboratories answer different parts of one translation problem—from biological information and system design to process development and pilot manufacturing.

View both laboratories BIOTEC source ↗