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Niscell

Facility

The floor plan is the argument.

Cells cannot be shipped in from somewhere cheaper. They are made in a graded room, near the clinician, under an accreditation that takes years to earn. This is the room. NiSCELL publishes the plan of it rather than describing it.

4
Grade B cleanrooms (NCR-1 to NCR-4)
2
Grade C rooms
cGMP
accredited by the NPRA
15th ed.
AATB Standards for Tissue Banking, followed for UC-MSC collection

Grade B is the background environment in which open handling of a cell product is permitted. Grade C is the background for the steps that precede it. Four Grade B rooms is a capacity statement, not an adjective: it is the number of products that can be in process at once without one waiting for another to finish.

The cleanroom floor plan

Schematic · not to scale

NiSCELL cell processing facility, cleanroom floor planA schematic plan of the NiSCELL cell processing floor. Four Grade B cleanrooms, numbered NCR-1 to NCR-4, sit at the east and west ends. Two Grade C rooms sit in the centre, one of them the preparation room. A clean corridor runs between the two ends, with a second clean corridor along the south side. Material crosses into the Grade B suites through seven pass boxes. People enter through Grade B change rooms and ante rooms. Water treatment sits at the north-east corner. The plan is schematic and is not to scale. Every room is listed again in the room schedule below.CLEAN CORRIDORCLEAN CORRIDOR 2NCR-4GRADE BCHANGEGRADE BCHANGEGRADE BNCR-3GRADE BROOM-2GRADE CMALEDDCFEMALEDDCANTEROOM 1ANTEROOM 2ROOM-1GRADE C · PREPARATIONNCR-1GRADE BWATERTREAT-MENTANTEANTECHANGEGRADE BCHANGEGRADE BNCR-2GRADE B

Pan the plan sideways to see the full floor

Figure 1 · NiSCELL cell processing floor, Petaling Jaya. Redrawn from the facility drawing. Room positions and adjacencies are as drawn; room sizes are uniform by grade and do not represent area.

  • Grade B cleanroom
  • Grade C room
  • Clean corridor
  • Change room
  • Ante room
  • Pass box

Room schedule

The same information as the plan, in words. Every room on the drawing is listed here.

NCR-4
Grade B
Grade B cleanroom. Opens onto the clean corridor through two pass boxes.
CHANGE
Change room
Grade B change room serving the west suites.
CHANGE
Change room
Grade B change room serving the west suites.
NCR-3
Grade B
Grade B cleanroom. Opens onto the clean corridor through a pass box.
ROOM-2
Grade C
Grade C room.
MALE DDC
Change room
Male change room, marked MALE DDC on the facility drawing.
FEMALE DDC
Change room
Female change room, marked FEMALE DDC on the facility drawing.
ANTE ROOM 1
Ante room
Ante room. The airlock between the change route and the clean corridor.
ANTE ROOM 2
Ante room
Ante room. The airlock between the change route and the clean corridor.
ROOM-1
Grade C
Grade C room, marked Preparation Room on the facility drawing.
NCR-1
Grade B
Grade B cleanroom. Opens onto the clean corridor through two pass boxes.
WATER TREATMENT
Utility
Water treatment.
ANTE
Ante room
Ante room serving the east suites.
ANTE
Ante room
Ante room serving the east suites.
CHANGE
Change room
Grade B change room serving the east suites.
CHANGE
Change room
Grade B change room serving the east suites.
NCR-2
Grade B
Grade B cleanroom. Opens onto the clean corridor through a pass box.
The client's annotated facility drawing: a CAD floor plan of the cell processing floor with the Grade B and Grade C rooms, the clean corridors, the change rooms and the pass boxes marked in colour.
Source drawingThe facility drawing the diagram above was redrawn from. It is published at the size it exists at, which is small, because the point of showing it is provenance rather than legibility. The vector plan is the readable one. The two say the same thing.

What is on the floor

The floor, photographed

The company’s own photographs of the rooms listed above, each at the resolution it exists at. Every frame is captioned with what it shows and where it was taken.

A wide view of a cleanroom: upright freezers and a CO2 incubator along the back wall, a refrigerated centrifuge on the bench, and monitoring panels above.
Figure 2 · Cleanroom equipment: freezers, CO2 incubator and refrigerated centrifuge.
The interior of a cleanroom suite, with a biosafety cabinet and freezers along one wall and a clear stainless work surface.
Figure 3 · Cleanroom suite interior.
Two gowned technicians working side by side at a biosafety cabinet.
Figure 4 · Open handling at a biosafety cabinet, cleanroom suite.
A gowned technician lifting a rack out of an open liquid-nitrogen dewar, vapour spilling over the rim.
Figure 5 · Cryopreservation. Vapour-phase liquid nitrogen storage.
A gowned operator reaching into an open upper cabinet among stacked white units with digital control panels.
Figure 6 · A gowned operator at an open cabinet.
A gowned technician taking labelled supplies from a shelved storage rack in a cleanroom store.
Figure 7 · Cleanroom store. Materials are held and issued against the batch record.

Every figure on this page can be checked against the plan above, and nothing is stated here that the plan cannot back. Square footage, room classifications beyond grade, and monitoring frequency are not published, because no source for them has been seen.

Accreditation and standards

  • cGMP accreditation

    The cell processing facility is accredited to current good manufacturing practice by the NPRA, Malaysia's National Pharmaceutical Regulatory Agency. It is audited by the NPRA and by the Ministry of Health.

    NPRA, Malaysia

  • BioNexus status

    BioNexus status is granted by Bioeconomy Corporation to qualified Malaysian biotechnology companies. It is a matter of public record and can be checked against the registry rather than against NiSCELL.

    Bioeconomy Corporation, Malaysia

  • AATB 15th edition

    Umbilical cord tissue is collected to the Standards for Tissue Banking of the American Association of Tissue Banks, 15th edition. The standard is the donor screening and collection discipline behind the UC-MSC product.

    American Association of Tissue Banks

Accreditation is not endorsement. These bodies accredit the facility and its processes. They do not endorse NiSCELL, and nothing here implies that any of them has approved a therapy.

The building

The NiSCELL headquarters in Kota Damansara, Petaling Jaya: a three-storey corner building in grey and oxblood, with the NiSCELL wordmark on the roof sign and above the ground-floor entrance.
Figure 8 · Bistari 'De' Kota, Kota Damansara PJU 5, Petaling Jaya. The cell processing floor is in this building.
Two cleanroom entry doors with viewing panels, each labelled with an engraved sign reading NISCELL CR4 and NISCELL CR3.
Figure 9 · Cleanroom entry doors, marked CR3 and CR4. The signage carries the same numbering as the plan above.

These are the company’s own photographs, at the resolution they exist at. They are small on purpose. A stock cleanroom blown up across the width of this page would look better and prove less.

Partners are welcome to inspect it.

The facility is audited by the NPRA and by the Ministry of Health. Research, clinical and commercial partners are welcome to see it, and project fit is assessed individually.

Partner with NiSCELL