CDMO Blog

Viral Aggregation in Downstream Processing of Lentiviral Vectors

Beckman Coulter CytoFLEX Flow Cytometer credit CCRM 500 px wideViral vectors are vehicles for delivery of therapeutic DNA in cell and gene therapies. With over 1,000 cell and gene therapy (CGT) clinical trials underway globally, there is a growing need to address challenges in viral vector manufacturing – both upstream and downstream. In a previous post, we outlined the key steps in downstream processing (DSP) for the manufacturing of lentiviral vectors (LVV). Achieving high concentration without aggregation is a significant technical bottleneck in manufacturing LVV. In this post, we will explore the concept of viral aggregation and its influence in every step of DSP for LVV.

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Posted: May 11, 2020 10:57:59 AM

Quality-by-Design Approach to Manufacturing Cell and Gene Therapies

Employee in GMP facility using quality by design approach

Implementation of a manufacturing process that assures a predefined quality of product is a critical requirement for the licensing and marketing of every cell and gene therapy (CGT) product.

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Posted: Apr 17, 2020 2:15:02 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

What Are the Benefits of an Automated High-Throughput Screening Process for Custom Cell Culture Media Development?

We are often asked if culture media development can be customized at the discovery stage of the product, and if feasible, how it can be done. In this post, we will outline one approach that can be considered to customize media development for discovery-based processes.

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Posted: Nov 21, 2019 10:59:14 AM

Five Steps to Ensure Your Cell and Gene Therapy Product Is GMP Compliant

Good manufacturing practices (GMP) facility for cell and gene therapiesWhen we think about cell and gene therapies (CGTs) what most often comes to mind is the early stage scientific innovation responsible for finding new ways to treat diseases. A lot of complex research and testing is performed to confirm Proof of Concept and that the therapy performs as desired. 

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Posted: Oct 30, 2019 3:59:26 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