Potential Introduction of ATMP-Specific GMP Standards in the EU
During June of 2016 the European Commission opened a three-month consultation on proposed Good Manufacturing Practice (GMP) guidance for Advanced Therapy Medicinal Products (ATMP).
March 30, 2017
Open Innovation in the cell therapy supply chain
In a world of distributed knowledge, and in Cell, Gene and Immunotherapy specifically, companies can’t rely exclusively on internal products and capabilities to effectively orchestrate the supply chain, meet manufacturing demands at scale and deliver end-to-end traceability and chain of custody throughout...
June 21, 2016
Stemming the Tide of Cybercrime: Protect your Patients' PHI
Last year (2015) 111,818,172 patients and healthcare individuals had their data exposed by the hacking of US companies working in the Healthcare industry. This year alone, in the four months from January to April, the PHI data of 2,352,180 patients has already been hacked. The numbers are staggering.
April 30, 2016
CD19 a starting point for CAR-T therapies
It has been breath-taking to see the clinical development of these genuinely curative therapies, which have provided hope to the previously incurable. However, these CD19+ targeting therapies do have both acute and chronic side-effects
April 20, 2016
Schrödinger's Temperature Monitor
In 1935 Erwin Schrödinger devised a thought experiment in which he described a paradox of quantum mechanics. A cat was sealed in a box with a flask of poison, a source of radiation and a radiation detector. The flask of poison was linked to the radiation detector and would break if the monitor detected radioactivity.
April 13, 2016
2020 Vision - CARAT in more detail
The CARAT project, funded by a EUR6 MILLION grant from the European Union, is focused on the integration of innovative tools and technologies, from TrakCel and a group of leading European partners, to develop an efficient and safe technology platform to manufacture CAR T-cell products for personalized treatment of cancer patients.
April 11, 2016