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CDMO Education Centre

Conventional cancer treatments (e.g. surgery, chemotherapy/radiation) do not specifically target cancer cells and, as a result, can cause extensive off-target damage, and complications for patients.

In the last several years, ground-breaking research and advancements in genetic engineering have led to the development of a novel treatment strategy, known as immune therapy, that is rapidly emerging as an alternative to conventional cancer treatments. By re-deploying the body’s own... Read More

Posted: April 26, 2019

New cell and gene therapies are rapidly being translated into the clinic. The potential for these new therapies is driving the industry to develop safe and reproducible cell culture systems. Increasingly, this has meant including the development of a unique, chemically defined (CD) and animal component free (ACF) medium as a standard part of the cell and gene therapy development process.

A few basic definitions are important to help navigate a market where defined media are... Read More

Posted: April 26, 2019

In the field of cell and gene therapy, there are two main types of viral vectors: adeno associated virus (AAV) and Lentivirus (LV). The manufacture of these vectors is dependent on the regulatory requirements dictated by its end use. AAVs are most commonly used to deliver gene therapies – meaning they will be administered directly to a patient. In contrast, LV is typically used as an input material to genetically modify cells used for cell therapies (e.g. CAR-Ts) and is not included in the... Read More

Posted: April 28, 2019

Making the Decision to Engage a Contract Development and Manufacturing Organization (CDMO)

There is no one-size-fits-all answer for cell and gene therapy developers seeking to determine why, and more importantly when, to outsource manufacturing or process development to a CDMO. Each developer will have unique needs depending largely on the stage of their technology. For instance, a pre-clinical company will have vastly different needs from a company in Phase... Read More

Posted: May 13, 2019

Simply put, a bioreactor is a stand-alone cell culture vessel enabled with sensors. Bioreactors differ fundamentally from traditional R&D cell culture in their ability to monitor and control key parameters such as temperature, pH, and dissolved oxygen (DO). Continuous, in situ monitoring of these parameters allow for a deep understanding of the growth environment of a given cell population -- creating avenues for process improvement. Paired controls enable dynamic, real-time responses... Read More

Posted: June 7, 2019

Understanding the cell and gene therapy (CGT) development process from start to finish often comes down to learning the language. For individuals more familiar with the early R&D steps in this process, terms like IQ, OQ and PQ – associated with later manufacturing steps – may be completely new. To get us started: IQ stands for installation qualification; OQ is operational qualification; and, PQ is performance qualification. Simply put, these are three steps in a validation process that... Read More

Posted: June 26, 2019

In a previous post we introduced chimeric antigen receptor T-cell (CAR-T) therapy - a new form of cancer therapy based on genetically reprogramming the body’s immune system that has been described as a “breakthrough” and “revolutionary” by the medical and scientific communities.

This post will explore how developing customized solutions for system closure... Read More

Posted: July 18, 2019

Lentiviral vectors (LVV) are a key component in the production of cell and gene therapies. They are most often used to deliver genetic material that will modify cells and confer therapeutic properties. Today, even with the proliferation of cell and gene therapies in development, LVV is still produced using legacy methods employed in basic research. Overcoming technical challenges in the scale-up of LVV production is a major focus for the industry. Scalable LVV production platforms are... Read More

Posted: July 26, 2019

Compliance with quality control (QC) standards is a basic requirement for products manufactured under good manufacturing practices (GMP) conditions. In this post we will explore the main compendial QC tests that ensure cell and gene therapies are safe for use in patients, and important considerations for integrating QC testing into the manufacturing process.

Compendial & Non-Compendial Tests

Compendial tests are standardized methods that are basic requirements for... Read More

Posted: August 13, 2019