Biophysical and Aggregate Characterization for the Development of Biologics

Small pharmaceutical companies are constantly seeking innovative solutions to streamline early clinical trials. Adaptive clinical trials offer important benefits to sponsors and patients, both from a commercial and ethical standpoint. These trials offer flexibility and efficiency, especially in the early stages, where trial protocols can be adjusted based on interim data, such as introducing new doses or modifying participant sample size. However, adjusting manufacturing demand during an adaptive trial can be complicated, and strict regulatory requirements present significant challenges. On-demand manufacturing provides a robust solution, allowing for real-time supply and demand adjustments and improved trial flexibility. This paper explores how on-demand manufacturing meets the operational needs of adaptive trials and aligns with regulatory expectations.

Dr. Tim Sandle's SmartNote series discusses how a risk-based approach to environmental monitoring helps facilities maintain control over their environment and supports quality assurance efforts. Plus, they highlight the importance of selecting appropriate monitoring locations and taking proactive measures based on monitoring results to ensure consistent environmental quality and mitigate potential risks to product safety and integrity. Part 1 covers the importance of selecting appropriate environmental monitoring locations and how a risk-based approach supports quality assurance efforts.

Learn about the role of environmental monitoring in a robust contamination control strategy to maintain product integrity and safeguard patient safety.

Dr. Tim Sandle's SmartNote series discusses how a risk-based approach to environmental monitoring helps facilities maintain control over their environment and supports quality assurance efforts. Plus, they highlight the importance of selecting appropriate monitoring locations and taking proactive measures based on monitoring results to ensure consistent environmental quality and mitigate potential risks to product safety and integrity. Part 2 of the series covers the importance of taking proactive measures based on environmental monitoring results to ensure consistent quality and mitigate potential risks to product safety and integrity.

Cleanrooms require strict environmental control to maintain sterility, prevent contamination, and ensure seamless operations. Without a proactive preventative maintenance (PM) program, various issues can arise, leading to costly downtime, contamination risks, and operational inefficiencies. Below are ten common cleanroom problems that can be effectively mitigated through proper PM practices.

In this case study, learn how TrueBinding leveraged G-CON’s prefabricated cleanroom PODs to achieve their mission critical goals.