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 ...

Developers might invest in small-scale equipment to produce packaging for stability studies in-house, or they might outsource production. Manufacturers should consider the benefits and risks to both ...

Harmonization of best practices and regulatory requirements will enable developers to find the best stability testing approach. Within the bio/pharmaceutical industry ...

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 ...

Stability evaluation occurs at various stages during the development of a drug product. At early development stages, it is used to select formulations and packaging configurations that are most likely ...

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 ...

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 ...