Tuesday, June 27, 2017 10:15:08 AM
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.
Recent PMCB News
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 08/13/2024 08:37:40 PM
- Form NT 10-K - Notification of inability to timely file Form 10-K 405, 10-K, 10-KSB 405, 10-KSB, 10-KT, or 10-KT405 • Edgar (US Regulatory) • 07/29/2024 08:05:11 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/17/2024 08:59:12 PM
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- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/17/2024 08:58:35 PM
- Form 3 - Initial statement of beneficial ownership of securities • Edgar (US Regulatory) • 05/30/2024 08:05:04 PM
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