The determination of protein content, as well as the aggregation index of the human monoclonal antibody (mAb) Adalimumab, are efficiently managed by the integration of analytical weighing and UV Vis spectrometry into a software-supported workflow. The usage of comparatively cost-efficient analytical instruments and the achieved gain in result quality in quantitative analysis and activity determination of human mAb are striking.
The Importance of Monoclonal Antibody (mAb) QC in Disease Treatment
mAbs are not only a therapeutic instrument, but represent a commonly used tool in laboratory research. Due to their specificity, they offer targeted stimulation or inhibition of cellular processes and are important tools in the treatment of cancer and autoimmune diseases. More and more interest is growing around mAbs and their potential use. Therefore processes related to mAbs' development, production, and distribution need to be controlled and reproducible to ensure that they are properly folded and stable, and thus safely applicable. Thanks to its low complexity, specificity and optimized time-to-result, UV Vis spectrometry represents a powerful, cost-efficient analytical technique especially for quality control purposes encompassing concentration and purity determinations. As successful analyses start with accurate sample preparation, a highly performing analytical balance is the ideal complement to a UV Vis spectrometer.
Pain Points of Adalimumab mAb Quality Control by Quantitative Analysis
The challenge for accurate and repeatable absorption measurement is the exact Adalimumab-type dependent dilution with a specific buffer solution to a pre-defined target concentration. This defines the corresponding absorption values at 280 and 320 nm, which should be between 0.05 and 0.5 A. In order to achieve the highest accuracy, the dilution process should ideally be performed gravimetrically on an analytical balance according to the validated SOP. The absorption at 320 nm is measured and deducted from the 280 nm absorbance in order to compensate for any turbidity effect, which could alter the protein's concentration.
Strict SOP Guidance Secures Result Integrity
To achieve the highest workflow security, integration of both analytical instruments (analytical balance and UV Vis spectrometer) into a software-supported workstation is desirable. The LabX™ laboratory software from METTLER TOLEDO enables such an approach with the integration of an Excellence analytical balance, such as the XPR205 for the sample dilution and a UV7 Excellence UV/VIS spectrometer for the subsequent UV measurement of the prepared samples. The specific workflows encompassing sample preparation and measurement, which are defined in the respective SOPs, are translated into corresponding LabX methods. This allows for excellent user guidance via the instrument terminal, where each step is displayed in the form of respective text messages and conformations defined by the workflow. All process information is saved in a secure, centralized database. With full support for regulatory compliance, LabX helps to meet FDA ALCOA+ requirements for data integrity.
