Article | May 26, 2023

Improving Quantification of Residual Host Cell And Mycoplasma Contaminant DNA For Cell And Gene Therapies With ddPCR™ Technology

Biotech scientist looking at test tube

All biotherapeutics, whether originating from patient cells or developed in cell lines from bacteria, yeast, plants, insects, humans, or other animals, must be free of contaminants. Mycoplasma is particularly problematic for cell-based vaccines, biologics, and gene therapies and potentially shuts down labs.

Bio-Rad's solutions for biotherapeutic contaminant detection and quantification include software tools that support regulatory compliance with U.S. FDA 21 CFR Part 11 regulations. These tools generate audit trails of protocol changes and use auto-gating and auto-thresholding features to minimize data handling and interpretation.

access the Article!

Get unlimited access to:

Trend and Thought Leadership Articles
Case Studies & White Papers
Extensive Product Database
Members-Only Premium Content
Welcome Back! Please Log In to Continue. X

Enter your credentials below to log in. Not yet a member of Cell & Gene? Subscribe today.

Subscribe to Cell & Gene X

Please enter your email address and create a password to access the full content, Or log in to your account to continue.


Subscribe to Cell & Gene