Lonza has analytical capabilities and expertise that encompass a wide range of technologies to support all stages of product and process development. These have been applied to monoclonal antibodies, antibody fragments, fusion proteins, chemically conjugated proteins, hormones and enzymes. Validated analytical methods are available to support release of early phase clinical material. These methods have also been successfully used to support license applications following product specific validation.
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The Lonza team has extensive experience in immunoassay development for impurities such as host cell proteins, components of culture media and purification ligands (e.g. Protein A). Generic host cell protein assays have been developed to support the development of NS0 and CHO cell lines. Assays based on hybridization, fluorescence and PCR are available for the assay of DNA.
Validated assays are used to support comprehensive process and cleaning validation programs used in the production plant. These include specific assays for products or cleaning reagents and measurement of total organic carbon. Such assays, for example, can detect a wide range of components in both rinse waters and swabs.
A wide range of physical and chemical methods is used to allow detailed characterization of proteins. These have been employed routinely in reference characterization and comparability studies.
A range of methods is used to define the glycosylation of recombinant proteins and antibodies. These included electrophoresis, HPLC and mass spectrometry methods.
Protein chemistry and conformation are defined by a range of methods including peptide mapping, capillary electrophoresis, N-terminal sequencing, mass spectrometry (various modes), amino acid analysis, circular dichroism and analytical ultra-centrifugation.
Pre-formulation and Stability Studies
Various analytical methods have been developed to support the design of liquid formulations and stability testing of the purified product and the product during processing and purification. We have experience conducting stability studies on over 50 protein therapeutics and over 20 products on stability.
Simple solution formulation design has routinely resulted in a shelf life of over three years for antibody-based products.