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
This blog post was originally shared at standardscoordinatingbody.org. Claudia Zylberberg, SCB Board Member, Akron Biotech December 17, 2018 I’m pleased to announce that one of the first standards advancement projects SCB was involved in, Ancillary Materials Used in Cellular Therapy Production, has culminated in the publication of a three-part documentary ISO standard (ISO/TS 20399): Part
The 60th Annual American Society of Hematology Annual Meeting in San Diego featured a number of presentations that highlighted the promise of CAR-T therapy. Researchers from the University of North Carolina Lineberger Comprehensive Cancer Center reported promising early results from a Phase Ib/II clinical trial that used autologous CAR-T cells to recognize and fight Hodgkin
The US Court of Appeals for the Federal Circuit upheld a previous decision by the US Patent and Trademark Office which awarded the intellectual property on CRISPR-Cas9 gene editing technology to the Broad Institute of the Massachusetts Institute of Technology and Harvard University, striking down an appeal by University of California, Berkeley and the University
The European Commission (EC) has approved the use of Novartis’s tisagenlecleucel (Kymriah) and Gilead’s axicabtagene ciloleucel (Yescarta), two chimeric antigen receptor T cell (CAR T) therapies. Already approved by the FDA at the end of 2017, these therapies have been hailed as a breakthrough in cancer treatment by using a patient’s own T cells to
The 11th annual Business of Regenerative Medicine: Innovation, Clinical Translation, and Entrepreneurship Symposium took place on July 17th-18th. The event was hosted by the Center for Cellular Immunotherapies and the Institute for Regenerative Medicine at the University of Pennsylvania in partnership with Case Western Reserve University, the Harvard Stem Cell Institute, the Parker H. Petit
One of the central challenges facing the regenerative medicine industry today is developing the workforce necessary to produce and commercialize advanced therapies and engineered tissues. The industry needs a well-trained workforce to grow; however, it is difficult to develop a workforce for an emerging industry which has yet to achieve the scale necessary to employ
Last week, Akron participated in the Phacilitate Automation Special Interest Group, a gathering of key industry stakeholders aimed at fostering discussion around the main challenges associated with developing and implementing automation solutions in an industry characterized by process variety and complexity, as well as the need to ensure data integrity. According to Dr. Rodney Rietze,
