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 blood brain barrier (BBB) is an important physiological wall protecting the central nervous system (CNS) from potentially harmful materials in the blood. However, this protective mechanism also blocks the entry of many drugs. The brain is one of the most challenging organs to access, often requiring the use of fine-tuned and precise drug delivery
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
Recently published research findings suggest that we may be able to prevent Cytokine Release Syndrome (CRS) through the oral administration of an FDA-approved drug. CAR-T therapy is a promising new approach to cancer treatment. However, a devastating side effect of CAR-T cell infusion is CRS. The patient’s infused activated T cells release interferon gamma (IFN-γ)
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
Electrospinning has been an attractive scaffold fabrication technique for over a decade capable of introducing micro-architectural ques to enhance tissue engineering modalities. Nonetheless, only a handful or architecturally relevant structures can be accomplished with this technique which require complex set-ups in order to be rendered properly. On the other hand, 3D Bio-Printing has emerged as
