CDMO Blog

Essentials of Auditing in the Manufacturing of Cell and Gene Therapies

Auditing in manufacturing of cell and gene therapies

Our previous posts on quality management systems and steps to ensure your cell and gene therapy (CGT) product is Good Manufacturing Practices (GMP) compliant alluded to auditing in the context of a larger manufacturing workflow. This post provides useful insights into auditing to help clients and contract manufacturing organizations (CMOs) understand this critical aspect.

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Posted: Mar 27, 2020 9:56:27 AM

Understanding Cryopreservation of Cellular Therapies

Cryopreservation of cells at CCRM

Cryopreservation is the process of using ultra-low temperatures to preserve living cells and tissues for a prolonged time period.

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Posted: Feb 13, 2020 2:13:44 PM

Induced Pluripotent Stem Cells – Part 1: Understanding Reprogramming

CCRM employees in lab

Stemming (pun intended) from the fundamental question in developmental biology around whether cellular differentiation could be reversed – like many transformative scientific discoveries – identification of induced pluripotent stem cells (iPSCs) was a curiosity-induced accident. In their foundational 2006 study, Takahashi and Yamanaka determined that fully differentiated adult skin cells could be reprogrammed back into stem cells by the over-expression of four genes (Oct3/4, Sox2, Klf4, c-Myc).

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Posted: Jan 29, 2020 1:58:32 PM

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