Dimethyl sulfoxide (DMSO) is an organic solvent that is widely used as cryoprotectant for freezing cells and tissues. Clinically, DMSO is considered a potent anti-inflammatory, nerve blocker (analgesic), diuretic, vasodilator and muscle relaxer. In cells, DMSO is used to induce differentiation, as a free radical scavenger, and most notably, to prevent ice formation during cryopreservation.
With the rapid growth in personalized medicine and cell/gene therapy, quick and consistent worldwide shipment of ancillary materials is becoming more critical. Shipping variables (such as temperature maintenance in transit, packing configurations, validations, etc.) are obviously important to consider, but contract terms are often overlooked, causing misunderstandings between the buyer and seller. Incoterms® are internationally-recognized
Mycoplasma is a class of bacteria that breaks the mold of typical bacterial classification – it does not have a cell wall. This feature makes it notoriously resistant to most common antibiotics like penicillin and cephalosporins, which are more effective on Gram-positive and Gram-negative cells (which have cell walls). Beyond being more resistant to go-to
Every year, the Medicine Maker, a global publication with a focus on the people that drive the development of small and large molecule drugs as well as advanced therapies, compiles a list of pioneers and influencers advancing the knowledge frontier, driving clinical application, and fostering industry growth. The annual Medicine Maker Power List is compiled
On Monday, March 18, the Standards Coordinating Body convened for a workshop on standards. The group discussed how standards are critical for the transfer of novel technologies from academia to clinical use. The FDA’s Judy Arcidiacono, one of the keynote speakers, discussed how standards are imperative to building the foundation of regenerative medicine innovation. The
Cell and gene therapies have demonstrated excellent clinical results across a range of indications with chimeric antigen receptor (CAR)–T cell therapies among the first to reach market. Although these therapies are currently manufactured using patient-derived cells, therapies using healthy donor cells are in development, potentially offering avenues toward process improvement and patient access. An allogeneic
We as a community have long used the term “current good manufacturing practices,” or cGMP, to describe a class of ancillary materials – or raw materials in certain geographies – produced in accordance with rigorous quality standards. We have done this to assure our clients, often the developers of advanced therapeutic medicinal products (ATMPs), that
Raw materials have been, and will continue to be, at the core of new sets of therapies coming out over the next decade. Why? Simply because they are either scarce or limited, such as off-the-clot AB serum, or because they encompass a high risk, which is the case for animal-derived components. For this type of materials, concerns