Experts discuss crucial aspects of measuring the stability of biologics, which exhibit greater variability in stability testing than do small-molecule drugs. A number of factors can influence ...

Biologics exhibit greater variability in stability testing than do small-molecule drugs, and maintaining a stable test environment is crucial. A number of factors can influence stability, especially ...

Maintaining the required solubility, stability, efficacy and potency of an engineered biotherapeutic protein is critical after its expression in a recombinant system. Analysis and optimization of the ...

Advanced kinetic modeling (AKM) can accurately describe the complex behaviors of biologics, reducing risks from the developmental stage all the way through last-mile delivery. Importantly, regulators ...

GMP release and stability testing are indispensable elements of the pharmaceutical sector’s quality assurance strategy. These testing protocols not only ensure that pharmaceutical products are safe ...

The purpose of the stability testing is to investigate how the raw materials or pharmaceutical preparations will change over time under the influence of temperature, humidity, and light, so as to ...

Stability testing is essential in the pharmaceutical and biopharmaceutical industries. These tests are performed to evaluate the stability of drug products under various environmental conditions. Once ...

This is an intensive two-day masterclass that will help you get a deeper insight into: Analytical Quality by Design (QbD) and Lifecycle Management The Accelerated Stability Assessment Programme (ASAP ...

Table 1. Factors to consider in real-time stability study (click to enlarge). Figure 1. Effect of material change on stability profile (click to enlarge). Figure 2. Correleation of stability failure ...

Continuing our successful series of stability meetings, this 8th event is essential for anyone concerned with the management and assessment of drug stability. This year we are partnering with Lhasa ...