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How biotechs cut corners in process development – without compromising quality

Discover just how much you can benefit from using mass spectrometry for Host Cell Protein analysis and ELISA coverage analysis in these video cases.

Video episodes

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Host Cell Protein analysis of bacteriophage product

HCP analysis on 6 bacteriophage drug substances expressed in 3 species

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Quantification of specific protein in a vaccine

Detection of a target protein in dilute virus samples with formaldehyde

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Residual biocatalysis in small molecule API

If your process uses added enzymes, residuals is a significant concern

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Analysis of residual protein in AAV product

Looking for problematic HCPs from SF9 cells and baculovirus vector

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HCP coverage comparison using ELISA-MS™

Comparing 5 CHO kits from 4 suppliers to find the one with the best coverage

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Quantification of viral, bovine, and human proteins

Analysis of a product utilizing a lentiviral vector expressed in HEK 293 T cells

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Investigating HCPs in mAbs using a native digest

A native digest approach lowered LOD - to reveal potentially problematic HCPs

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HCP purification optimization - from harvest to final DS

Optimization of purification process using PI and MW data of each HCP

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Comparison of HCP removal strategies

Evaluation of HCPs after 3 different combinations of purification steps

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Qualification report used for IND application

First example of regulatory authorities accepting IND without ELISA data

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HCP coverage analysis using immunocapture and LC-MS

Measuring the coverage of your HCP ELISA without a null cell line

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Convincing documentation of HCP Clearance in PPQ runs

Comparing the consistency of PPQ runs and following specific Host Cell Proteins

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Problems with non-dilutional linearity of ELISA

This biotech company had issues with the validation of its ELISA

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HCP analysis for uncommon expression systems

What to do, when no commercial ELISA kit fits your expression system

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mAb biosimilar was cleaner than the originator

Investigation of why one mAb biosimilar was more stable than the originator

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