June 18, 2024 || Robert Ossig
Unlocking the Future: Exploring Cutting-Edge Cell and Gene Therapies The world of medicine is in the middle of a transformative evolution following the advent of cell and gene therapies. These cutting-edge treatments offer promising avenues for tackling diseases at their root causes, providing hope for conditions that were previously deemed…
June 11, 2024 || Robert Ossig
In the complex landscape of pharmaceutical and biopharmaceutical product development, the initiation stage of technology transfer (TT) is critical for ensuring successful scale-up and manufacturing. This stage involves a multidisciplinary approach, where business, technical, and regulatory considerations must be meticulously assessed to determine the feasibility and strategy for TT. Effective…
June 11, 2024 || Robert Ossig
The Planning stage of technology transfer (TT) is crucial for ensuring a seamless transition of processes, resources, and knowledge from the Sending Unit (SU) to the Receiving Unit (RU). However, this stage involves complex coordination across functional groups, each with unique roles and responsibilities. This blog explores the key activities…
April 26, 2024 || Robert Ossig
An Overview of the Execution Stage The Execution stage is the heartbeat of pharmaceutical technology transfer, where the meticulous planning of the Readiness stage comes to fruition. This critical phase involves executing Process Performance Qualification (PPQ) and ensuring operational readiness and compliance at the Receiving Unit (RU). Here, we delve…
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.
