CDMO Blog

Road to success: Understanding Good Laboratory Practice for cell and gene therapies

Scientist developing cell and gene therapies at hood in lab

Good Laboratory Practice (GLP) studies are essential for generating nonclinical study data supporting drug product submissions or applications for human use. According to the most basic definition, GLP is a set of principles that can be applied to ensure the quality and integrity of non-clinical laboratory studies. GLP provides a means to standardize the results of pre-clinical studies that come from different labs, in part by imposing increased documentation requirements based on standard procedures. Standardization is the driving force behind GLP.

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Posted: Jan 10, 2020 1:36:17 PM

Considerations for the Use of Stable Producer Lines in the Manufacturing of Lentiviral Vectors

A-cell-culture-plate-is-handled-by-a-scientist

In an introductory post on lentiviral vector (LVV) manufacturing for cell and gene therapies (CGTs) we touched upon the challenges with transfection-based protocols for producing LVVs at large scale. Here we will take a closer look at the use of stable producer cell lines as an alternative to transient transfection for the manufacture of LVVs.

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Posted: Oct 30, 2019 3:04:35 PM

How Can a Contract Development and Manufacturing Organization (CDMO) Advance a Cell & Gene Therapy Product?

Contract Development and Manufacturing Organization for cell and gene therapies

Making the Decision to Engage a CDMO

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Posted: Oct 22, 2019 3:44:48 PM