April 15, 2024 || David Shenberger
The US Food and Drug Administration (FDA) has launched a new Advanced Manufacturing Technologies (AMT) Designation program aimed at accelerating the implementation of technologies that drive speed to patient and enhanced sustainability. For innovative companies, this provides an exciting opportunity to improve processes and drive sustainability. This initiative is part…
January 15, 2024 || Robert Ossig
During a pharmaceutical technology transfer (TT) project, the Readiness Stage plays a pivotal role by establishing the groundwork for a successful transition. This phase involves meticulous planning, coordination, and execution of key activities across various functions, each contributing to the readiness of the Receiving Unit (RU) for Process Performance Qualification…
December 6, 2023 || Robert Ossig
A Personalized Medicines Overview Personalized medicine, also known as precision medicine, represents a paradigm shift in healthcare, emphasizing the customization of medical treatments to individual characteristics and challenging the existing pharmaceutical manufacturing paradigm. Within this evolving field, various categories of personalized medicines have emerged, each aiming to optimize therapeutic outcomes…
February 9, 2022 || Joe Micsko
Need for Speed is the name of the game when building a facility to manufacture ATMP products. With a heavy focus on an accelerated schedule and getting your product to market faster this brings unique risks. Converting some project risk factors into success factors could change your whole dynamic and…
May 28, 2020 ||
Technology Transfer and the Product Lifecycle Technology transfer is integral to the lifecycle of virtually every pharmaceutical product. Tech transfer enables a product to advance from the development lab into clinical manufacturing and then scale-up to commercial production. As demand grows, tech transfer is instrumental in adding additional manufacturing capacity…
September 9, 2019 ||
Results from the PDA survey on Technology Transfer have now been published documenting key highlights and findings from the participant response! This publication which was co-authored by one of CAI’s principal consultants, Beth Haas, can be found in the PDA Bookstore. Learn more about Beth below.
