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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. Remember, only those questions listed in the package will be discussed during the INTERACT meeting.

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Biopharma Update on the Novel Coronavirus: October 20

The Pharma Data

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. .

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Modernizing cell culture processes for the next wave of genomic medicine

Pharmaceutical Technology

Researchers have relentlessly worked through the barriers to create lifechanging treatments for patients in need. “As For example, researchers have developed a two-plasmid cotransfection system. Another immediate benefit is improved batch-to-batch consistency — something regulators are expected to tighten the rules on in coming years.

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Overcoming inefficiencies to improve access to cell and gene therapy 

Drug Discovery World

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. Drug discovery researchers usually partner with a CDMO to provide support through the development, manufacturing, and clinical supply required to bring a drug to market.

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CRISPR breakthroughs: New solutions for common diseases

Drug Discovery World

Years of development and fast-paced research have continued to unlock its potential, expanding how CRISPR can be used to treat, detect, and prevent common diseases such as cancer and Covid-19. CRISPR diagnostics have successfully detected various pathogens, including RNA viruses (eg.

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Delivering on the promise of gene editing

Drug Discovery World

As gene editing technologies like CRISPR progress toward clinical study, researchers must continue to advance new approaches and address inherent challenges, explains Jon Chesnut, PhD, Senior Director, Cell Biology R&D, Thermo Fisher Scientific. Topping the list of alternatives are lipid nanoparticles (LNPs) and electroporation.