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
Scientists from Boston Children’s Hospital and Massachusetts Institute of Technology (MIT) have used alpaca-derived nanobodies to create a novel approach to CAR T cell therapy that addresses the challenge of treating patients with solid tumor cancers. Currently, CAR-T cell immunotherapy has been applied to the treatment of non-solid tumors such as acute lymphoblastic leukemia (ALL).
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
Following successful clinical studies, the FDA and regulatory authorities around the world have approved the use of axicabtagene ciloleucel (Yescarta™) for patients with large-B-cell lymphomas and tisagenlecleucel (Kymriah™) for adults with certain types of non-Hodgkin lymphoma. Despite its success as a novel way of treating cancer, physician scientists are realizing that 30%-50% of patients who
The Akron team recently attended the 4th Innate Killer Summit, held in in San Diego, California. The conference provided an excellent opportunity to participate in presentations and workshops covering cutting-edge research, recent clinical data, and commercial developments in the growing NK cell therapy market. More than 250 attendees collaborated and shared knowledge on ways we
The preservation of biological samples is critical to the success of experimental studies and clinical treatments in the emergent field of immunotherapy. Cryopreservation – keeping cells at sub-zero temperatures – slows metabolic activity significantly, enabling storage and transportation, as well as a return to functionality upon thaw. Of course, it’s not as simple as placing
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
