With the product lifecycle moving so fast, many organizations may ask the question, "how can we effectively measure quality?"
With the product lifecycle moving so fast, many organizations may ask the question, "how can we effectively measure quality?" What can an organization do to keep up with this new pace of business while ensuring the visibility that quality deserves? The answer is Risk Management.
In this white paper learn about how Risk Management provides the framework for handling adverse events in a systematic way, the elements of Risk Management and how they help to identify, prevent and mitigate risk throughout an organization and how Risk Management will allow an organization to reduce the risk of product failure in design.
http://www.etq.com/eu/pharmtech/whitepaper-risklifecycle/
The Role of On-Demand Manufacturing and Derisking in Accelerating Early Clinical Trial Success
June 4th 2025Small 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.
Fast and Efficient Sialic Acid Clone Selection Using Lectin-Based High-Throughput Screening
June 2nd 2025Glycosylation is a common and critical post-translational modification that affects protein function and therapeutic efficacy, making its monitoring and accurate quantification essential for drug development.