Accelero Bioanalytics GmbH, the Berlin-based bioanalytical service provider with expertise in custom-made ligand binding assays, is pleased to announce a close cooperation with Synlab Clinical Trial GmbH, a leading contract research organization providing exceeding services for Phase I up to Phase III clinical drug development.
Within this collaboration, Accelero Bioanalytics will advance its customized assay development and validation services for preclinical and clinical drug development. Accelero Bioanalytics runs an Applied Biosystems ViiA7 Dx Real-Time qPCR Platform for 384well assays, the only ViiA7 Dx system installed under GLP regulations in Germany.
Synlab Clinical Trial GmbH stands for extraordinary experience in the clinical development of therapeutics like small molecules, monoclonal antibodies, virus particles. High quality state-of-the-art analytical equipment enables the discovery of clinical chemistry, haematology, protein biomarker multiplexing. Drug PD characterization also includes huge PBMC isolation expertise with subsequent flow cytometry analysis (FACS).
Both businesses provide services which fully comply with ICH GCP and GCLP guidelines in combination with Good Laboratory Practice (GLP) regulations. A biosafety level 2 environment secures the handling and processing of genetically engineered specimen e.g. like anvanced cell-based vaccine therapeutics.
Accelero Bioanalytics GmbH offers bioanalytical services to small and medium-sized R&D biotech companies as well as GMP production facilities.
The current assay portfolio includes:
- PK assays for nucleic acid therapeutics like siRNA, miRNA, microRNAs.
- PD assays for biomarkers, cytokines, complement activation, etc.
- Immunogenicity testing (ADA assays).
- Impurity tests according to ICH Q2 R1, e.g. for residual host cell DNA detection.
- Master cell bank (MCB) and working cell bank (WCB) characterization.
- Biodistribution studies of cell-based advanced therapeutic medical products (ATMP), as well as for plasmid vaccines.
- (Trans)gene copy number quantification, plasmid copy number quantification.
- Transcript expression analysis, biomarker discovery on the RNA level.
- And many more...
For more than 19 years Synlab Clinical Trial GmbH has been providing laboratory services for clinical trials to the global pharmaceutical industry and CROs. Meanwhile Synlab Clinical Trial GmbH has grown into a European Organisation of its own right with impressing analytical capabilities, going well beyond standard clinical laboratory services.
The service covers the complete analytical workflow in clinical trials like:
- Clinical Chemistry and Immunochemistry: Roche COBAS 6000, Cobas c501, Cobas e601, Abbott Architect Plus
- Hematology: Siemens Advia 2120, Abbott Cell Dyn Sapphire, Sysmex XT2000i, Sysmex CA1500.
- • Immunology, Biomarker: Siemens Immulite 2000, Tecan Sapphire 2, Luminex MAGPIX
- • Coagulation Assays.
- • Fluorescence activated cell sorting (FACS): Becton Dickinson FACS Canto II (2x), FACS Calibur, FACS Sample Prep Assistant III.
Synlab Clinical Trial GmbH builds on long-term, standing and successful strategic partnerships with international CROs and the pharmaceutical industry. Since 1993 Synlab Clinical Trial GmbH has contributed substantially to more than 1.800 clinical trials.