Camargo

MAY 2, 2021

CMC: Innovative technologies, product manufacturing, reagents, starting materials, critical product components, novel delivery device qualification, and complex software issues. Scope and design of definitive animal trials and clinical trials. Identify critical development issues or deficiencies to address.

Gene Therapy 155

Gene Therapy Gene Packaging Packaging 155

pharmaphorum

JUNE 1, 2021

This technology can also play an important role in supporting virtual clinical trials. Many countries have introduced serialisation legislation which requires product identifiers to be affixed to each package to provide traceability throughout the distribution supply chain. The threat of illegal online pharmacies.

Medicine 52

Medicine DNA Pharmacy Production 52

The Pharma Data

OCTOBER 19, 2020

DB ( Becton, Dickinson and Company ) received a CE mark for its BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes for assessing immune function in COVID-19 patients. Army Medical Research and Development (USAMRDC ) initiated a Phase I clinical trial of its novel vaccine against COVID-19. Please read more here. .

Vaccination 52

Vaccination Vaccine Trials Clinical Trials 52

Drug Discovery World

MARCH 13, 2023

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. Before 2019, CGT drug developers still had a young, academic mindset, ordering reagents, materials, and equipment haphazardly and assuming they would show up when needed.

Gene Therapy 52

Gene Therapy Gene Manufacturing Development 52

Drug Discovery World

DECEMBER 15, 2022

Now, after nearly 35 years of research and more than a decade of preclinical progress, several different gene editing modalities are being tested in early phase clinical trials. Early phase clinical trials for gene editing therapies. Gene editing challenges and potential solutions.

Gene Editing 52

Gene Editing Gene In-Vivo Genome 52

Drug Discovery World

JULY 18, 2023

These methods offer safer CAR T-based therapies, laying the foundation for clinical trials and the rapid development of a new generation of CAR T cells for both autologous and allogeneic use. This approach achieves knock-in efficiencies at multiple loci (singly or in combination) comparable to AAV-based methods.

DNA 98

DNA Genome Genomics RNA 98