Analysis of the recombinant protein content of your vaccine
Do you develop or manufacture any type of vaccine? And are you looking for the most extensive vaccine characterization of batches, process steps and residual impurities? To ensure patient safety, heighten drug stability, not risk any developmental delays or another vital part of vaccine developm...
Do you develop or manufacture any type of vaccine? And are you looking for the most extensive vaccine characterization of batches, process steps and residual impurities? To ensure patient safety, heighten drug stability, not risk any developmental delays or another vital part of vaccine development?
We can help you quantify residual agents and host cell proteins (HCPs), confirm the biologic’s protein sequence, evaluate post translational modifications (PTMs) and resolve the intact mass of your recombinant proteins. At Alphalyse, we utilize mass spectrometry and thus offers several services for vaccine analysis. It is both useful in your process development and final product analysis.
Even newer vaccines based on a viral matrix, such as lentiviral or adenovirus-based vectors, are susceptible to our approach for HCP analysis and structural analysis of the viral envelope proteins. The problem with HCP ELISAs is that they often do not accomplish a sufficient HCP coverage since viral vaccines are complex and often based on several host systems. Our services, however, provide you with a complete overview of the HCPs in your samples – in all host systems and all sample types, such as early harvest samples and cleaned-up clinical batches.
How we ensure you the highest quality
We perform all our tests according to the ICH Q6B guidelines – Test Procedures and Acceptance Criteria for Biotechnological/Biological Products. By using robotic automation throughout the sample preparation and data analysis, we guarantee quick turnaround time and the most detailed vaccine analysis on the market. And with more than 100 completed HCP projects in only 2 years, we have seen all sample and host types out there. If your host organism(s) are sequenced, we can identify and quantify every single HCP in your sample.