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Biotechnological product manufacturing (including biopharmaceutical manufacturing areas, vaccine production facilities, all sterile preparation manufacturing areas such as GLP-1, stem cell and gene therapy application fields, and biomedical material production facilities) involves production technologies that require a high degree of care and precision. These processes are carried out in cleanrooms at various safety levels—specifically with particle counts ranging from Class 1,000 to 100,000—especially to prevent contamination.
Biotechnological production which have developed in recent years in our country; requires special expertise for production areas design to project designing, from construction works with risk analysis in line with the projects to validations, IQ/OQ and FAT&PAT testing to be conducted in order for the production area to start working as correct and target-specific, and finally to getting GMP certificate as a result of inspections made by the authorities by making GLP (Good Laboratory Practices) and GMP (Good Manufacturing Practices) documentation. Trying to resolve these fundamental processes, that require expertise and experience each in itself, separately in our country with providers causes both cost and time losses.
For this purpose, BioGenuslab was founded with the aim of raising all these fundamental processes under one roof. BioGenuslab's Foundation aim is the cost-effective "Turnkey" projects during the period from production-specific design of biotechnological production areas until getting GLP/GMP certificate, and it has started its activities with the high experience expert team in the field and Turkish agencies of the worldwide companies specialized in this regard.