NewLab BioQuality - Analytical Services for the Quality Control of Biopharmaceuticals

NewLab BioQuality is a leading German contract service organisation providing not only the commonly used methods in quality control but also innovative and tailor-made solutions for the quality control of biopharmaceuticals. These include cell bank testing, impurities such as host cell DNA and host cell proteins, viral and prion clearance studies and bioassay validation. NewLab BioQuality operates in full compliance to GMP/GLP standards based upon the latest regulatory expectations.

CELL BANK TESTING

The basis of any GMP-compliant development of a biopharmaceutical is a thoroughly characterised cell substrate. Starting with the master cell bank, issues such as identity, purity, and stability are addressed. In addition, the working cell bank and the postproduction cells must be tested. NewLab BioQuality assists in setting up a testing package for your specific cell bank.

DETERMINATION OF IMPURITIES SUCH AS RESIDUAL DNA AND HOST CELL PROTEINS

The monitoring of possible impurities throughout the downstream process is critical in assuring the safety of the product. Freedom from impurities such as host cell DNA, host cell proteins and endotoxins must be demonstrated. Based on internally validated analytical procedures, NewLab BioQuality can demonstrate freedom from these impurities by adapting and validating established, in-house methods and procedures to client-specific matrices. In addition NewLab BioQuality can offer tailor-made solutions by developing and validating new testing methods for customer-specific requirements.

VIRAL AND PRION CLEARANCE STUDIES

One approach in addressing the viral or prion safety of a biotechnological product is to assess the capacity of the purification process to inactivate or remove viruses and/or prions. NewLab BioQuality performs such validation studies routinely, which quantitate the virus-reduction of a specific downstream step within a purification process. Our testing systems and calculations of reduction factors are in strict adherence to the ICH recommendations. The safety evaluation studies performed by NewLab BioQuality are globally recognised and accepted.

CHARACTERISATION OF THE FINAL PRODUCT AND LOT-RELEASE TESTING

NewLab BioQuality AG offers a wide range of analytical services used to determine the identity, purity, integrity and stability of biopharmaceutical products. Methods include SDS-PAGE, western blot, isoelectric focusing, peptide mapping and chromatography methods such as reverse phase, ion exchange and size-exclusion. In addition, carbohydrate analysis, capillary electrophoresis, bradford assay, BCA and spectrophotometric analysis are available.

BIOASSAYS INCLUDING METHOD DEVELOPMENT AND VALIDATION

NewLab BioQuality has validated, viral-based bioassays for determining the potency of interferon a2b and interferon ß as described in the European Pharmacopoeia. The statistical evaluation of the bioassay is performed using the parallel line model. Utilizing its experience with bioassays, NewLab can also develop customized bioassays to meet your requirements.

STABILITY STUDIES FOR PROTEINS AND PLASMIDS

During the pharmaceutical development process, the stability testing of drug substances and drug product is one of the main issues addressed by regulatory authorities. NewLab assists in designing ICH compliant stability testing programs and identifying the suitable stability-indicating methods for both, proteins and plasmids used for gene therapy. Storage and analysis of the testing samples can be conducted at NewLab insuring compliance to all regulatory requirements.

With more than ten years of collaboration with both international pharmaceutical companies as well as with smaller biotech companies, NewLab BioQuality has a wealth of experience from which it can draw in assisting clients in determining and solving their quality control requirements.