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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

ICH Q8B characterization of complex products

The complexity of VLP-based vaccines makes characterizing them challenging

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Troubleshooting ELISA results using mass spectrometry

A change in ELISA standard may have a dramatic effect on measured HCP levels

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Mock and harvest HCP profile comparison

Custom ELISA antibodies will only be as good as the mock used to immunize

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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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