Transferable techniques for the characterization of viral vectors


Watch this on-demand webinar to learn how compliant techniques for protein characterization can be applied to viral vector modalities

Dr Colette Quinn, Senior Director of Business Development at Waters Corporation

Viral vectors represent a part of one of the fastest growing therapeutic segments, gene therapy, and they are transforming the lives of patients through disease cures and are now playing a role in the fight against the pandemic of COVID-19.

In this SelectScience webinar, now available on demand, Dr. Colette Quinn, Senior Director of Business Development at Waters, describes how lessons learned from traditional biopharmaceuticals can be applied to the characterization and surveillance of viral vectors.

Thinking of benefiting from it, but missed the live event? Register now to watch the webinar at a time that suits you or read on for highlights from the question-and-answer session.

In the anion exchange experiment, you tried two different examples with one having a higher resolution. What is the source of this difference?

QC: Anion exchange chromatography for different serotypes is not a platform method, we cannot take the same conditions and expect it to work well for each serotype. For each example we used different buffers and different salts, we also performed studies to look at the temperature and see how it affects the separation. Each time you go through a new serotype, there is still some method development required to achieve the best separation.

For the identification of viral proteins, you shared an example of a C8 column less efficient than the C4 column. Could you comment on why there is this difference?

QC: The difference between columns C8 and C4 was not only the length but also the size of the pores. The pore size is where there is the biggest problem due to the restricted diffusion. When selecting a column, it is important to not only think about the length of the column, but also to make sure that the pore size is correct, so as not to observe any broadening of the peaks.

Is there any data comparing anion exchange data to AUC because AUC gives more accurate data on empty fill purity level?

QC: AUC can measure this partial that we know other techniques cannot. Pfizer performed a comparative study with several different techniques (CDMS, AUC, SEC-MALS and UV-Vis). For the most part, the techniques will agree with each other, including AEX and AUC, but there will be disagreements as you have more and more partials in your sample.

Are there any analytical questions about viral vectors that cannot be properly addressed with existing techniques? What new practice would be helpful?

QC: The greatest need is an empty partial fold that can be performed in a compliant atmosphere and be able to characterize it to see if the correct transgene is present. It would be great to be able to perform something like that in two dimensions. To be able to use something like 2D LC to be able to probe the viral vector to see if it is the right sequence, the right transgene, and if there is any part of the host DNA present while being able to retain the sample is a gap in what is currently available and may prove useful in the future. The other need is for size exclusion chromatography columns with larger pore sizes that work best with larger viral vectors.

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