XTalks

OCTOBER 19, 2023

An assay development scientist combines deep biological and biochemical expertise with practical laboratory skills to develop tests that can answer specific biological questions or drive the drug discovery process. This could involve tweaking experimental conditions, changing reagents or redesigning the assay.

Scientist 59

Scientist Development Research Compliance 59

Pharmaceutical Technology

FEBRUARY 15, 2023

“At the small scale, manufacturing between 1 ml and 10 ml is typically not problematic , but it’s not straightforward to replicate processes and technologies once you want to produce tens of litres of formulations,” says Dr Crowe, who manages a team that develop novel analytical assays related to LNPs and nanomaterials for drug delivery.

Bioassay 130

Bioassay RNA Development Drugs 130

Advarra

NOVEMBER 29, 2022

There have been recent signals indicating the Food and Drug Administration (FDA) plans to provide greater support for CGT, addressing key issues continuing to impede their development. No Prescription Drug User Fee Act (PDUFA) fee is associated with the INTERACT meetings. Recent Problems in Cell and Gene Therapy Development.

Gene Therapy 52

Gene Therapy Gene Production Clinical Trials 52

The Pharma Data

DECEMBER 2, 2020

Food and Drug Administration (FDA) for Onivyde (irinotecan liposome injection) for study patients with small cell lung cancer (SCLC) who progressed following a first-line platinum-based regimen. The drug is a small-molecule inhibitor of the S. Paris-based Ipsen secured Fast Track designation from the U.S. in Mainland China.

Drugs 52

Drugs Gene Editing Genome Genomics 52

pharmaphorum

FEBRUARY 3, 2021

While achieving the Nobel Prize spotlight would have been enough to impress, CRISPR-Cas9 gene editing is part of a growing list of technologies granted Investigational New Drug (IND) applications with early data from clinical trials supporting its safe use in edited cells re-introduced into a patient. Improving on impressive first steps.

Gene Editing 98

Gene Editing Gene DNA Engineer 98

The Pharma Data

OCTOBER 27, 2020

Food and Drug Administration (FDA). ” The single-reaction panel targets five regions of the viral genome and provides excellent accuracy and sensitivity. “Most real time qPCR-based assays target only two or three targets on the viral genome.” SAN DIEGO , Oct. About Agena Bioscience. SOURCE Agena Bioscience.

Genetic Analysis 52

Genetic Analysis Genome Genomics Reagent 52

The Pharma Data

OCTOBER 14, 2020

They can be cultured to test drugs. They offer access to an intact genome which allows whole genome sequencing without a background. 2) Prenatal Diagnostics : circulating throphoblasts in maternal blood can provide a comprehensive, non-invasive picture of a fetus as well as access to an intact genome.

Clinical Trials 40

Clinical Trials Clinical Trials Trials Genomics 40

The Pharma Data

OCTOBER 14, 2020

The AOP Orphan Group manufactures 80% of its drugs in Europe and has more than 20 subsidiaries and representative offices across the whole of Europe as well as in the United Arab Emirates and Israel. Food and Drug Administration granted Breakthrough Therapy designation to France-based Inventiva’s experimental NASH treatment lanifibranor.

Clinical Trials 52

Clinical Trials Clinical Trials Manufacturing In-Vivo 52