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 130

DNA Therapies Assay Development Production 130

Agency IQ

JULY 21, 2023

The next chapter in the ctDNA story: Still promising, not ready for prime time A recent workshop summed up the state of play for circulating tumor DNA. As dying cancer cells degrade, their cell contents are released into the patient’s circulation, affording the possibility of detecting fragments of DNA that are unique to the cancer.

FDA 40

FDA Clinical Trials DNA Treatment 40

Drug Discovery World

APRIL 25, 2024

According to Grand View Research, the global cell line development market was valued at $4.81 billion in 2022, a figure that is expected to grow at a compound annual growth rate (CAGR) of 9.81% from 2023 to 2030 1. Bacterial cell lines such as E. coli have their own set of benefits however.

Vaccine 147

Vaccine Production Pharmaceuticals Therapies 147

Drug Discovery World

MAY 11, 2023

In addition, their cumbersome developmental process limits their use for fast-tracked new modalities, such as DNA-based vaccines. This approval could pave the way for LC-MS to transition more frequently into a good manufacturing process (GMP) environment, where it can be used as a release assay for regulatory documentation. 2022): 947.

Production 130

Production Vaccine Immune Response Therapies 130

Elrig

APRIL 29, 2024

Srinivasan has led the development of multiple computational pipelines to process data from different next generation sequencing techniques with applications in oncology, genome editing systems including CRISPR-Cas mediated DNA editing, and ADAR-mediated RNA editing.

Bioinformatics 59

Bioinformatics Molecular Biology Drugs Cell Based Assays 59

Agency IQ

FEBRUARY 2, 2024

The protocol and statistical analysis plan should clearly specify the plans for specimen collection, sample analysis and related clinical outcomes depending on the biomarker assay development and validation strategy. Second, the EMA is working on a separate guideline for platform trials , floating a concept paper in 2022.

Clinical Trials 40

Clinical Trials Trials Treatment Production 40