GMP Cell Banking
Austrianova is a B2B company that offers a full GMP service for living eukaryotic human and animal cells. We can prepare cell banks and process cell lines in a US-FDA compliant manner. We can grow up adherent or non-adherent qualified cells (supplied with the necessary documentation as to sterility and adventitious micro-organisms). Cell Banking is performed at our manufacturing facility located in Thailand Science Park, Pathumthani, Thailand. This facility operates under a Factory License issued by the Thai-FDA via Thailand Center for Excellence in Life Sciences. All production steps are under an audited Good Manufacturing Practice (GMP) quality regime. Corresponding documentation is well established. After production and completion of release tests the banks will be stored at -80oC or in liquid nitrogen prior to shipment to the Sponsor or prior to shipment to a dedicated biopository facility.
We are a state-of-the art cell processing facility able to manufacture material for clinical trials up to a scale of hundreds of syringes/vials per campaign for cells, and up to about 5000 syringes/vials for encapsulated cells. Due to our location we are able to manufacture at a very competitive prices, whilst adhering to US-FDA GMP standards. We have been extensively audited by our clients.
Our GMP facility is situated on the 4th floor of a new laboratory tower at Thailand’s premier research and development location, Thailand Science Park. Our access controlled 300m2 facility comprises storage for quarantined, released and finished goods, with refrigerated storage at -80oC, liquid nitrogen, -20oC and 4oC. The storage facility is monitored 24/7 by electronic alarms and our staff immediately notified if any parameter approaches its set limit. Our core GMP production suite comprises eight rooms grouped round a central Production D room. The rooms include gowning, material entrance, washing, clean equipment storage, janitorial, and waste out via a pass-though autoclave. The rooms follow a strict 15 Pascal pressure gradient from the central D room outwards.
All production work is carried out in a unique, custom designed and built isolation unit that provides the A in B in C environment and the unit resides within the D Room. This isolation unit comprises of four separate working chambers, linked via internal airlocks, and with two access laminar flow unit to allow material into and out of the isolation unit. No room air is used in the isolation unit which is filled with triple filtered medical grade gasses, allowing us to create any necessary gas environment within the unit. The cell culture chamber, used for unfreezing, expanding and processing cells has an attached incubator chamber. The encapsulation chamber allows cells to be encapsulated using Austrianova’s proprietary Cell-in-a-Box technology if necessary. The microscope and centrifuge chamber allows both cell manipulation as well as electronic cell documentation, whilst the filling chamber, which contains a state of the art automatic filling machine, allows cells, or encapsulated cells to be automatically and volumetrically filled into vials or syringes. All chambers are accessed via glove ports by operators standing in the D-Room.
Our GMP Quality System is electronic and fully on-line. Working to US-FDA standards we document Personnel, Vendors, Material, Storage Conditions, Facility Information, Equipment, Rooms and Methods in the system, Our electronic Batch Records are fully GMP compliant and document all steps of the process in real time, as well any deviations, followed by impact or risk assessments, investigations where necessary, root cause, CAPA and change control.
After processing, cells or encapsulated cells are frozen down using controlled rate conditions and are stored at -80oC or liquid nitrogen.
Our facility also comprises a Quality Control laboratory for all in process and product specific tests, as well as for microbiological tests on the facility, rooms and equipment . Safety tests such as sterility, mycoplasma and endotoxin are conducted by our outsourced US-FDA-audited partner in Germany.