Add like
Add dislike
Add to saved papers

Bio-CoDa: A new analysis class to ensure accurate and precise monoclonal antibody CQA estimation and control.

Monoclonal antibody production processes control critical quality attributes (CQAs), which are the measures that provide proof of a product's identity and quality. Critical decisions rely on the accuracy and precision of these measures, as well as their appropriate statistical treatment. Many measures require special attention. For example, the charge heterogeneity CQA measured by ionic exchange chromatography reports proportions or percentages of the total integrated peak area of known species. Since proportions sum to a constant (1 or 100%), they fall into a special class of data called compositional data that have a unit sum constraint and therefore an inherent correlation. However, these measures are often analyzed assuming independence which is incorrect. Estimating statistics with incorrect assumptions can lead to inferential failures (e.g., shelf life failures), or can lead to missing important structural patterns in the data. Presented here is a new class of analysis methods for CQAs compositional data called Biologic Compositional Data Analysis (Bio-CoDa). The method is based on the elegant solution to analysis issues by Aitchison (1986). An introduction to the Bio-CoDa methods with rational is presented as well as examples demonstrating its strengths. Biotechnol. Bioeng. 2017;114: 2001-2010. © 2017 Wiley Periodicals, Inc.

Full text links

We have located links that may give you full text access.
Can't access the paper?
Try logging in through your university/institutional subscription. For a smoother one-click institutional access experience, please use our mobile app.

For the best experience, use the Read mobile app

Mobile app image

Get seemless 1-tap access through your institution/university

For the best experience, use the Read mobile app

All material on this website is protected by copyright, Copyright © 1994-2024 by WebMD LLC.
This website also contains material copyrighted by 3rd parties.

By using this service, you agree to our terms of use and privacy policy.

Your Privacy Choices Toggle icon

You can now claim free CME credits for this literature searchClaim now

Get seemless 1-tap access through your institution/university

For the best experience, use the Read mobile app