Benefit from access to the right analytical methods available when needed
We offer access to analytical capabilities that apply to monoclonal antibodies, bispecific antibodies and more complex structures, including new molecular formats.
We can help you with the establishment and implementation of a phase-appropriate analytical test strategy. Our validated analytical methods are available to support the release of early phase clinical material and have also been successfully used to support license applications following product-specific validation.
Our platform methods
We provide a wide range of platform methods for different applications which will be implemented where appropriate to save time and cost.
Bioanalytical testing methods
Potency is a critical quality attribute of the products we manufacture. For licensing of biopharmaceuticals, development and validation of a potency assay(s) should be included in the specifications for the drug substance and/or drug product.
We offer tailored bioassay method development, method transfer and method validation to ICH Q2 (R1) standards.
We have over 20 years' experience across a wide range of products provided by subject matter experts embedded in the Bioassay Method Development team (ELISA, cell based assay and SPR), supporting the global Lonza network.
Characterization methods
Characterization methods provide detailed biochemical and biophysical analysis of customer products to ensure they are as intended. Characterization of Reference Standards is required for IND, BLA and for commercial manufacture, as well as process changes. Our characterization team also supports cell line selection, process development and investigations.
We offer characterization analysis of both mAbs as well as non-mAbs.
Stability studies
Stability studies provide real time evidence on how the quality of a drug substance or drug product varies over time under the influence of different environmental factors. They also establish a shelf life and recommended storage conditions.
Stability testing uses a range of analytical methods for testing of product characteristics, identity, charge profile, purity, activity and safety. The data generated overtime is continuously monitored.
We have over 10 years' experience with stability testing of drug substance and drug product, providing data to support regulatory submissions. Following approval, we perform post-license stability studies to confirm stability consistency of bulk drug product, which is licensed for distribution.