biosafety4u.berlin GmbH, a service provider for genetic engineering facilities in Germany, and Z.A.S. Zentral Archiv Service GmbH announce a joint cooperation for external GLP and GMP cell biobanking in a regulatory context.
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biosafety4u.berlin GmbH, a service provider for genetic engineering facilities in Germany, and Z.A.S. Zentral Archiv Service GmbH, a Rhenus company specialized in archiving and biobanking in compliance to GLP and GMP regulations, announce today the creation of a joint cooperation to establish a holistic service offer for external cell biobanking in a regulatory context.
Z.A.S cell biobanking capabilities can help clients to maintain a long-term storage of valuable production cell lines 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. Applicable both for human and animal therapeutic use.
- Advanced Therapy Medicinal Products (ATMP) intended for human use e.g., like 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., like Pichia pastoris production lines, cellular agriculture cell lines of animal or plant origin, irrespective of a genetical modification.
„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 Act for Genetic Engineering).
Dr. Benjamin Bader, Managing Director @ Z.A.S. Zentral Archiv Service GmbH, adds: „Regulated biobanking can be troublesome 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”.
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, retirement phase. 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 the regulated industry from Pharma and Health economy. 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 storage capacities. 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 Pathogenic Ordinance).
For more information please contact:
Mobile: +49 157 75726939
Z.A.S. Zentral Archiv Service GmbH
Dr. Benjamin Bader
Phone: +49 395 5705 114
A brief handout about Z.A.S. regulatory cell biobanking capabilities can be downloaded here.