biosafety4u.berlin GmbH, a service provider for genetic engineering facilities in Germany, and Z.A.S. Zentral Archiv Service GmbH announce a cooperation on external GLP and GMP cell biobanking in a regulated environment.
Please feel free to download and distribute this announcement on regulated cell biobanking as you wish.
biosafety4u.berlin GmbH, a service provider for genetic engineering facilities in Germany, and Z.A.S. Zentral Archiv Service GmbH, a Rhenus company specialising in GLP- and GMP-compliant archiving and biobanking, today announce a cooperation to offer a holistic service for external cell biobanking in a regulated environment.
Z.A.S cell biobanking capabilities help clients store valuable production cell lines long term for a variety of applications:
- Master cell banks (MCB) / Working cell banks (WCB) for GMP production of biopharmaceuticals including monoclonal antibodies and peptide/protein based biosimilars and/or originators, virus-based gene therapeutics, and vaccines. For both human and veterinary use.
- Advanced Therapy Medicinal Products (ATMP) intended for human use e.g. human blood products, human stem cell-based products, living biotherapeutics like bacteria, or phage-based disinfectants or therapeutics.
- Master cell banks (MCB) / Working cell banks (WCB) to produce cell culture-derived novel food and food ingredients e.g. Pichia pastoris production lines, cellular agriculture cell lines of animal or plant origin, whether genetically modified or not.
„This partnership will enable our clients to benefit from a broader service portfolio “, says Christian Lange, Quality Manager GLP and GCLP @ biosafety4u.berlin GmbH. He has also been approved by the local competent authority as external Biosafety Officer for Z.A.S. Zentral Archiv Service according to §29 GenTSV (German Genetic Engineering Safety Ordinance).
Dr. Benjamin Bader, Managing Director @ Z.A.S. Zentral Archiv Service GmbH, adds: „Regulated biobanking can be challenging due to continuously changing and increasing demands on safety aspects. Together with biosafety4u.berlin we provide a full spectrum biobanking service to our clients now including safety assessments and consultation”.
About biosafety4u.berlin
The company is a client-oriented service provider supporting biolabs and genetic engineering facilities in all aspects of biological safety throughout the entire facility life cycle: Project phase, operational phase, decommissioning. biosafety4u.berlin serves novel food producers, distributors, start-up hubs, cell-line developers as well as in vivo research facilities with its expertise and is currently approved by competent authorities in seven federal states of Germany.
About Z.A.S. Zentral Archiv Services
Z.A.S. offers archiving, information management and digitization services for regulated industries in the pharmaceutical and healthcare sectors. Z.A.S. maintains a genetic engineering safety level 2 facility for cell banking storage at different temperatures between +5 and -196°C with virtually unlimited capacity. The storage capabilities at Z.A.S. are certified according to Good Laboratory Practice (GLP) as well as Good Manufacturing Practice (GMP) regulation. Z.A.S. holds a manufacturing authorization (§13 AMG) and the required permits for handling S2 human and T2 animal pathogenic material according to §49 IfSG (Infection Protection Act) and §2 TierseuchenErV (Animal Pathogens Ordinance).
For more information, please contact:
biosafety4u.berlin GmbH
Christian Lange
christian.lange[at]biosafety4u.berlin
Mobile: +49 157 75726939
Z.A.S. Zentral Archiv Service GmbH
Dr. Benjamin Bader
benjamin.bader[at]zas-archiv.de
Phone: +49 395 5705 114
A brief handout about Z.A.S. regulatory cell biobanking capabilities can be downloaded here.
