Pharmaceutical Technology

FEBRUARY 3, 2023

“For each production process, you have to generate the plasmids in huge quantities with GMP quality and then do a transient transfection, meaning you mix them with a transfection reagent and add that to the cells in a very controlled way,” explains Faust. For example, researchers have developed a two-plasmid cotransfection system.

Genomics 244

Genomics Genome Medicine Gene Therapy 244

FDA Law Blog

MAY 19, 2023

Baumhardt, Senior Medical Device Regulation Expert & Richard A. Previously, the EUA template only required these studies for Multiplex Respiratory panels in which a new instrument was used with the proposed device; however this De Novo was for a simple point-of-care device to detect SARS-CoV-2 viral targets only.

Reagent 40

Reagent Genetics Contamination Marketing 40

XTalks

MARCH 11, 2025

While RT-PCR methods can handle some level of multiplexing, they do require specialized, contamination-free environments. The result was a prepackaged, off-the-shelf reagent kit that provided reliable quantification for a wide variety of influenza mRNA vaccine constructs.

Vaccination 64

Vaccination Vaccine Development Manufacturing 64