Since its inception, SOTIO has supported 14 clinical trials of oncology therapeutics developed leveraging multiple platform technologies. On the Business of Biotech, Global CEO Radek Špíšek takes a deep dive into the development, HR, and funding strategies deployed to build the company’s IL-15, immune cell therapy, and antibody-drug conjugate candidates. Listen now and subscribe so you never miss an episode.
The first article in this two-part series by Marcelo Trevino covered details associated with economic operator responsibilities, overall QMS considerations, and common challenges during implementation of the EU’s Medical Device Regulation (MDR) and the EU’s In Vitro Device Regulation (IVDR). This article focuses on typical challenges experienced during the technical documentation assessments conducted by the notified bodies.
By Todd Owens and Raghu Vadlamudi,Donatelle
Process validation is critical in medical device manufacturing, but it often doesn’t get the attention it requires. This article offers guidance for creating validation processes and helps identify the personnel who should create and maintain them.
The world’s growing on-demand economy and the idea of real-time fulfillment of goods and services now drive business, whether it’s a business-to-consumer transaction at Amazon Prime or a business-to-business exchange at companies like Protolabs.
Creating a high-resolution picture and subsequent 3D atomic model of a biological macromolecule is a complex process. Embeddable RFID tags from HID Global were chosen for sample identification, due to their tiny footprint and proven track record to work in cryogenic environments and the ability of HID for custom tag designs to meet high demands.