September 5, 2024 || Robert Ossig
Transitioning from technology transfer (TT) to routine commercial production poses significant challenges for biopharmaceutical companies. Ensuring a seamless handover from the TT Team to the Receiving Unit (RU) requires meticulous coordination across multiple functions to mitigate risks and incorporate lessons learned. This blog explores the critical roles and activities involved…
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…
March 18, 2024 || Connie Leech
Aseptic Processing Technology advancement innovations such as robotics, artificial intelligence, & rapid test methods have continued to ensure the production of safer, more effective medical products, thereby enhancing patient outcomes and overall satisfaction. Manufacturers can consistently deliver sterile medications and devices by employing state-of-the-art aseptic processing techniques, reducing the risk…
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…
