Roots Analysis

APRIL 15, 2024

These complex entities, such as antibodies, antibody drug conjugates, cell therapies, gene therapies, and therapeutic proteins, are highly specific molecules that are designed to precisely target biomarkers associated with a particular disease pathway.

Manufacturing 40

Manufacturing Production Contract Manufacturing Contamination 40

Advarra

MARCH 31, 2023

The use of engineered genetic materials in clinical trials is rapidly expanding, with potential applications for genetic vaccines, gene-modified cellular therapies, and gene therapies.

Engineer 52

Engineer Genetics Clinical Research Research 52

Roots Analysis

SEPTEMBER 20, 2023

In this form of therapy, patients are injected with living and intact human cells that are deemed to be capable of providing therapeutic benefit. It is important to highlight that cell and gene therapies have been used to treat an array of medical conditions for which no other treatments are available.

Manufacturing 40

Manufacturing Production Contamination Gene Therapy 40

Drug Discovery World

JANUARY 19, 2023

This paid-for advertorial by Catalent appeared in DDW Volume 24 – Issue 1, Winter 2022/2023 One significant challenge in the manufacturing of cell and gene therapies is the production of high-quality plasmid DNA (pDNA). Figure 1: The integrated development pathway for cell and gene therapies.

DNA 52

DNA Manufacturing Gene Therapy Gene 52

Drug Discovery World

AUGUST 10, 2022

To prevent these potentially fatal side effects, the US FDA recommends that manufacturers who generate CAR T cells using retroviral or lentiviral vectors screen out batches that contain more than four transgene copies per cell 13. Meanwhile, droplets that do not contain the template strand only emit weak fluorescence.

Manufacturing 98

Manufacturing Gene Genome Genomics 98

Drug Discovery World

FEBRUARY 8, 2023

Svea Cheeseman , Refeyn, explains why better efficiency is needed to advance the production of viral vectors for use in gene therapies. Adeno-associated viruses (AAVs) are a promising, widely used vector for delivering gene therapies. Data were provided by the Cell and Gene Therapy Catapult (London, UK).

Gene Therapy 52

Gene Therapy Gene Antibody Production 52

Roots Analysis

FEBRUARY 1, 2024

In the absence of suitable temperature controlled packaging solutions, the products packaged, such as vaccines, biologics, cell and gene therapies might get exposed to extreme ambient temperatures. These containers are available in a single use, as well as reusable format.

Packaging 40

Packaging Packaging Containment Production 40