Erkrath, 40699 GERMANY
NewLab BioQuality AG is a leading German specialist for contract quality control on biotechnically produced pharmaceuticals and blood derived products. NewLab is GLP-certified (Good Laboratory Practice) and works in compliance with the current guidelines and recommendations issued by ICH, EMEA and FDA. Compliance with these established and recognised quality standards has been re-verified in numerous audits conducted by our clients. With a background of years of co-operation with renowned pharmaceutical companies such as Aventis AG, Roche AG and Bayer AG NewLab can draw on a wealth of day to day practical experience.
NewLab continuously fills up its range of service. The development of a biotechnically produced pharmaceutical can now be supported from its start in cellbanking through the monitoring and clearance-validation of contaminants during down-stream-processing down to the release testing of the final product.
cell line characterization and safety testing of prokaryotic and eukaryotic cell banks (MCB, WCB, EPC/PPCB and bulk harvest)
process evaluation for
– viruses and prions (inactivation or removal)
– impurities (residual DNA, host cell proteins, media components, …)
– contaminants (adventitious viruses, mycoplasma, endotoxins, …)
– product characterization (identity, purity, integrity)
– lot release testing
plasmid analysis and DNA sequencing according to GLP
development of production processes in mammalian cell cultures
This portfolio in biopharmaceutical quality control provides a unique position within the field of contractors in Germany and Europe alike. Large pharmaceutical producers frequently use the strong proficiency in biotech specific methods. Small biotech development companies benefit additionally.