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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... 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.... 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... 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... 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... 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;... 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... 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... 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-... Read More

Posted: August 13, 2019

In Part 1 of our series on lentiviral vector (LVV) manufacturing we covered scale-up of upstream processing steps. In this post we will look at the key steps in downstream processing (DSP). The industry “gold-standard” for recovery of purified and concentrated LVV is... Read More

Posted: August 22, 2019

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... Read More

Posted: September 13, 2019

Cellular immunotherapies (e.g. CAR-T cells) are primarily used as an autologous therapy to treat cancer. As such, these therapies are currently generated in small batches for each patient. To generate enough modified cells for a single treatment, cells are expanded in... Read More

Posted: September 26, 2019