article thumbnail

FDA INTERACT Meetings: Early Interactions for Cell and Gene Therapy Sponsors

Camargo

Advances in scientific knowledge and growth in the cell and gene therapy space have led to a new and exciting era of medicine for patients, as well as a new motivation for regulators to provide clear, efficient pathways for product developers. Background: The Advancement of Cell and Gene Therapies.

article thumbnail

Cell analysis system could streamline cell and gene therapy manufacturing 

Drug Discovery World

PerkinElmer has launched the Cellaca PLX Image Cytometry System, a first-of-its-kind benchtop platform that enables researchers to assess multiple Critical Quality Attributes (CQAs) of cell samples in a single automated workflow, including cell identity, quality and quantity. . ” . . ” . .

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Regulatory Trends in Cell and Gene Therapies

Advarra

The field of cell and gene therapies (CGT) is constantly evolving, and there has been significant progress in this area of research. However, despite the promise of these therapies, the regulations governing them lag the science, which in turn hinders the clinical translation of these novel medicines.

article thumbnail

Overcoming inefficiencies to improve access to cell and gene therapy 

Drug Discovery World

The cell and gene therapy (CGT) landscape has grown significantly in the past year. Between the 24 therapies already approved by the FDA 1 and a marked increase in clinical trials, widespread accessibility to precision medicine feels within reach.

article thumbnail

Modernizing cell culture processes for the next wave of genomic medicine

Pharmaceutical Technology

With scientists fervently developing mRNA vaccines, nucleic acid therapeutics, and viral vector-based gene therapies, clinicians are set to have a growing number of tools available to treat a wide range of conditions, from infectious diseases to genetic disorders and more.

Genome 244
article thumbnail

Key Trends in Non-Viral Transfection Market

Roots Analysis

In fact, non-viral vectors are significantly less expensive than their virus-based counterparts, implying the potential for use in the development of more affordable gene therapies. Currently, highest number of patent for non-viral transfection reagents and systems is filed in North America region.

Reagent 52
article thumbnail

This week in drug discovery (7-11 August)  

Drug Discovery World

The news headlines this week reflect the level of interest in cell & gene therapies (CGT) in the sector, particularly CAR-T, but also the importance of research collaborations to bring these therapies to patients. News round-up for by DDW Digital Content Editor Diana Spencer.