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Re: frosr6 post# 70617

Tuesday, 06/27/2017 10:15:08 AM

Tuesday, June 27, 2017 10:15:08 AM

Post# of 144812
Austrianovas state of the art cGMP production facilities comply with international regulatory requirements and marry a Swiss/German quality assurance system with extensive technical and regulatory expertise to provide the support you need for efficient product development.


The hi-tech facility employs a custom-built multi-unit isolator that mimics the classical GMP clean room environments but allows a higher quality, reproducible product to be made through continuous online monitoring as well as physical isolation of the product at all times from the highly skilled operator.
Crucially, the higher quality final productis achieved at lower cost than that produced in a conventional GMP facility.


Cells4GMP has experience with a number of standard mammalian cells lines such as HEK293, CHO etc., as well as stem cells. Nevertheless, cells are grown to the clients specification and Cells4GMP consults with clients for their needs. MCBs and WCBs of up to 100 vials can be manufactured according to GMP which are cryopreserved for storage.


MCBs and WCBs are required for cell therapies such as stem cell therapies but also for the production of biotherapeutics such as monoclonal antibodies and recombinant proteins. Fully characterized cell lines and cell banks are a regulatory and quality prerequisite in all clinical development stages as well as for commercial use.
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