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
Aging is characterized by a functional decline in many physiological systems. Cellular senescence, a central component of aging, is a cell-intrinsic stress response programmed to impose stable cell-cycle arrest in damaged cells. These senescent cells are not completely dead but do suffer loss of function or irreparable damage, and they have been implicated in diseases
From January 22 – 25, Phacilitate Leaders World and the World Stem Cell Summit will be co-located in Miami, FL. This popular event will attract 2,000 attendees, 150 exhibitors and 300 speakers representing every major stakeholder group. On January 22 at 3:20 pm, Dr. Claudia Zylberberg, CEO will be participating in a panel titled “SCB: Developing a standards
Myocardial infarctions, commonly called heart attacks, affect thousands of people every year. Myocardial infarctions occur when a blockage in the arteries causes a decrease in blood flow to the heart. This leads to irreversible damage to the heart muscles, loss of cardiac cells, and scarring. Cell therapy seeks to regenerate lost cardiac cells with cardiac
The MIT Center for Biomedical Innovation (CBI) leads the Biomanufacturing (BioMAN) program, an initiative that joins leaders from industry, academia, and government to address collective challenges in biologics manufacturing by creating a pre-competitive environment in which stakeholders can share best practices and engage in collaborative work. Akron Biotech attended this year’s summit in Cambridge, MA
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
Ischemic stroke, which is caused by a clot that blocks blood flow to the brain, damages brain tissue and, as a result, can be lethal or severely impair cognitive and motor functions. Previous work has shown that perturbations in noncoding RNAs and epigenetics mediate some of the postischemic changes that cause brain damage. Certain microRNAs,
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
Spinal fusion surgery is often the answer to cases of severe intervertebral disc degeneration where the cushioning that sits between the spinal vertebrae becomes damaged, causing patients to experience back and neck pain. However, the surgery does not restore native structure or mechanical function. Degeneration of the intervertebral disc (IVD) is due to combination of
