At this webinar, find out about inline measurement of protein aggregation during biopharmaceutical production.
Protein aggregation is one of the most frequent causes of protein instability. Considered a critical quality attribute, this is an essential indicator in drug manufacture, whether upstream or downstream.
The development and production of pharmaceutical products such as monoclonal antibodies may be affected by protein aggregation. This phenomenon occurs in various production, storage and sample handling conditions. As well, this occurs in a large range of protein concentrations and formulations. The presence of aggregated forms of proteins is potentially problematic for these therapeutic products. It brings with it a risk of immunogenic and pharmacokinetic problems.
Consequently, it is essential to fully characterize, quantify and check the level of aggregates, their nature and their distribution. In the context of an effective analytical inspection strategy for biological and biopharmaceutical products, these checks need to be performed regularly.
Characterization and inspection
Although most aggregates form during the upstream operations, they may also occur during the downstream processing, for example when unsuitable conditions have been selected.
Successful bioproduction therefore requires thorough knowledge of the processes and a rigorous definition of their parameters.
This is why, during this webinar, we will be explaining how our Asuryan UV-Vis spectrometer can be used to acquire knowledge concerning the processes, whether during the R&D phases to reduce the time-to-market, or directly inline for early detection of protein aggregation to avoid reduced product yields.
Proteins, which are highly reactive molecules, are present in small quantities. They require a spectroscopy method suitable for such low concentrations. Thanks to its high sensitivity, UV spectroscopy is ideal for this type of measurement.
Furthermore, the adaptability of the Asuryan’s UV spectroscopic measuring system enables various different probes to be used. These cover the wide ranges of protein concentrations encountered in the different industries and during the various steps for their production.
An acknowledged player in spectroscopy and the owner of a large number of patents, INDATECH has designed Asuryan, an inline measuring and inspection solution ideal for therapeutic production:
- Measurement sensitivity and accuracy at low concentrations,
- Repeatability over time thanks to an internal reference measurement,
- Simultaneous measurements at several points with different protein concentrations.
See all our case studies involving Asuryan.