
A-Bio is located at the Gemini Building in Singapore Science Park II. It occupies four levels
with a combined floorspace of over 7,100m2:
In addition, there is a boilerhouse and an emergency power generator located separately north of the main building.
The GMP manufacturing facility has a number of cleanrooms designed to meet both the US FDA and EU EMEA GMP requirements. The cleanrooms are classified according to ISO 7 and 8, and EU Grades C and D. Biosafety cabinets and LAF located in the cleanrooms provide ISO 5 and EU Grades A/B areas.
There are 5 separate Air Handling Units (AHUs) in the HVAC system, with 4 units serving the cleanrooms utilising once-through airflow to achieve better cleanliness, segregation and reduce cross-contamination. A validated Building Automation System (BAS) controls the HVAC system to maintain the set pressure, temperature and relative humidity.
The cleanrooms are segregated into dedicated processing and support areas. Surrounding the cleanrooms is a dual corridor system (Clean/Return) to allow for unidirectional personnel and material flow entering/exiting each suite to minimise the potential cross-contamination. Each of the cleanroom has separate airlocks for entry and exit with differential pressure cascades for further segregation.
A-Bio operates the following on-site utilities:
| Clean Utilities |
Purified Water (PW) by Reverse Osmosis (RO)
Water for Injection (WFI)
Clean Steam
|
| General Utilities |
Process Chilled Water
Plant Steam
Process Compressed Air
|
| Process Gases |
N2, O2 and CO2 |
| Waste Water Treatment |
Biokill, Neutralisation |
| Solid Waste Treatment |
Heat Decontamination |
| Gaseous Exhaust Treatment |
Filtration |
|
The processing cleanrooms are served with Water-for-Injection, Clean Steam, process gases and Clean-In-Place (CIP) to enable flexible and efficient manufacturing tasks to be performed. Aseptic manipulations are performed in laminar airflow units or biosafety cabinets to ensure aseptic integrity.
The following summarises the bioreactor capacities in A-Bio process development and GMP production:
| Process Development |
8x2L (Glass), 4x10L (Glass), 2x10L (Stainless Steel), 1x40L (Stainless Steel).
|
| GMP Production |
1x40L, 1x200L and 1x500L for the production of clinical grade material.
|
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