NewLab BioQuality AG

Max-Planck-Strasse 15A
Erkrath, 40699 GERMANY
Germany

Phone: +49-211-9255-300
Fax: +49-211-9255-333

Description:

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.

Technology/Services Portfolio
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.

Special expertise:
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, …)
protein chemistry
– product characterization (identity, purity, integrity)
– lot release testing
bioassays
plasmid analysis and DNA sequencing according to GLP
stability testing
– proteins
– plasmids
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.