3 Journeys to Commercialising Advanced Therapies
The advanced therapy industry is constrained by its focus on manufacturing. The drive to reduce COGS, close and automate processes, create assay platforms, etc. are all critical.
January 30, 2018
Leveraging Cellular Orchestration Platforms to Support the Cell Therapy Supply Chain
This blog post is a summary of the main takeaway messages of a panel titled, “Leveraging Cellular Orchestration Platforms and Other Systems to Support the Cell Therapy Supply Chain.” assembled and moderated by TrakCel's Rob Margolin ...
July 10, 2017
I was asked recently by a senior executive of a cell therapy developer to summarise ‘Why TrakCel?’. He wanted to share this with some of his colleagues that had not been involved directly with us to date. The organisation was clear on the business value of introducing a cellular orchestration platform so ‘Why a COP?’ wasn’t the exam question.
July 27, 2017
The Impact of Cellular Orchestration Platforms on Cost of Goods
Find out more info on how Cellular Orchestration Platforms (COPs), such as TrakCel, are designed to improve supply chain performance for cell and gene therapies (CGTs).
June 12, 2017
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
Conducting Trials and Commercial Activities with Cellular Orchestration Platforms
When the FDA recognised that the ‘orchestration’ of Provenge was Dendreon’s biggest manufacturing challenge a significant regulatory marker was placed for the management of cell therapy products.
November 2, 2016
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