Accelero Bioanalytics GmbH proudly announced today that the company has received full authorization from Berlin´s local LAGeSo authority for the bioanalytical processing of genetically modified organisms (GMO). The notification allows for the operation of safety level S2 laboratories (registration No. 661/12) according to the German genetic engineering safety regulations (Gentechniksicherheitsverordnung, GenTSV).
This includes the storage, bioanalytical processing, and analysis of genetic modified biomaterials collected in preclinical or clinical studies of Advanced Therapy Medicinal Products (ATMPs). The facility is also accredited for projects of the biosafety level S2, which in combination enables the analysis of potential human pathogenic specimen.
The registered S2 laboratories are situated right in the Berlin city center, and can be reached from Berlin central station only in five minutes. The accreditation process was essentially accelerated by the excellent contacts to the LAGeSo, Berlin´s local regulator for GxP and biosafety affairs. Accelero Bioanalytics and its partner synlab clinical trial GmbH are located next to the authority, a unique but also comfortable situation for the application of future projects in this field.
Accelero Bioanalytics originally filed an application for a Pichia pastoris transgene copy number qPCR project, which now was approved by the authority. The company offers real-Time RTqPCR and qPCR services for the characterization of GMO which are intended for the use in large scale GMP production of biopharmaceuticals. MCB and WCB qPCR assays are validated according to ICH Q2 R1 guideline, and are provided via the company´s ViiA7 Dx qPCR 384well System.