Many cancer therapies that have emerged in the past decade have been developed to increase anti-tumor immunity. Specifically, these therapies promote innate and adaptive immune responses and equip the body’s own immune system to work as a weapon against tumors. Currently, most approaches have focused on enhancing T cell responses. One such approach targets inhibitory
The problems that arise when scaling up from small research batches to pilot-scale production to large-scale manufacturing aren’t always what you might expect them to be. While the concentration of the components in the formulation may not change, plenty of subtle idiosyncrasies noticed in the research phase can become huge hurdles on the commercial end
Cardiovascular disease is the leading cause of death in the world. This field has been the focus of several novel stem/progenitor cell-based therapies. These therapies have shown promising results in human clinical trials. Studies have demonstrated that cardiac progenitor cells (CPC; c-kit+/Lin−) and cardiomyocyte-derived cells (CDCs) from human neonatal cardiac tissue can reduce heart scar
The ISCT 2019 Early Stage Professional Abstract Award is given to individuals within 10 years of receiving their terminal degrees or entry into the cell and gene therapy field, who provide top-scoring abstracts. Akron is proud to present one of these three ESP awards to David Bishop, BMedSc(Hons), MBBS, FRACP FRCPA, Westmead Hospital (Australia). Bishop’s
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
