ISR’s CDMO Outsourcing Models report dives into three approaches to contracting manufacturing work, the motivations behind using each approach, and details on which methods earn the greatest satisfaction among users.
Just as the U.S. and European bioprocessing supply systems have seen more robust growth than ever before, China’s domestic demands for single-use bags, cell culture media, and purification resins are all on the rise. BioPlan’s Top1000Bio database of global bioprocessing facilities has tracked industry capacity and employment growth over 15 years.
Through a breadth of facilities, resources, and experience, Grace’s FCMS can serve customers’ needs from coast to coast, ensuring supply chain efficiency, safety, and security throughout the product development journey.
Dr. Gene Lee, Vice President of Technical Development at AltruBio, sat down to discuss getting the developability question right and why it’s important to understand your end game as early as discovery.
Finding the best commercial partner for your program starts with obtaining mission-critical technical capabilities. The best place to begin a serious conversation about the firm’s true potential to provide that value should start with a dialogue about the technology transfer process.
In this article, Mark Witcher, Ph.D., discusses the many failure modes of FMEA and risk priority number (RPN), comparing and contrasting it with system risk structures (SRS) and adjusted risk likelihood (RPN). He concludes that one of these is more useful than the other for pharma and medical devices; which one is it?
Data and the digitization of assembly equipment work together to deliver competitive advantage to pharma partners in terms of product quality, continuous improvement, de-risking maintenance and change management, and the ability to deliver unique identities and traceability for every assembled device.