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 ...
In recent decades, shelf-life prediction is increasingly recognized as an important and necessary part of any new product development. Fully aware of this, CD Formulation, a New York-based CRO company ...
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 ...
The importance of capability and capacity of a CDMO partner to deliver drug substance and product testing should never be underestimated, considering the increasing complexity of compounds in ...
In the pharmaceutical industry, ensuring the stability of drug formulations is of paramount importance to guarantee their efficacy and safety. CD Formulation, a leading company in the field of drug ...
Merck, a leading science and technology company, has launched the first all-in-one, validated genetic stability assay of its kind. The Aptegra ™ CHO genetic stability assay leverages whole genome ...
The introduction of biologicals into our drug armamentarium is complicating stability testing. For these complex molecules neither physicochemical data nor bioassays alone provide the complete picture ...
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 ...
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 ...
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 ...
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 ...