Browsing by Author "Silva, Ana Carolina Clarindo"
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- Biologicals : processing and stability issuesPublication . Silva, Ana Carolina Clarindo; Pinto, Ana Isabel Fernandes; Mang, AndréProtein aggregation poses a significant challenge to the stability of biopharmaceutical products both in routine unit operations and throughout the product's shelf-life. Unit operations such as freezing/thawing, mixing, filtration, and filling tend to induce protein aggregation, mainly due to interfacial stress, among other factors. In some cases, adjusting the formulation can reduce aggregation, while in others, opting for more suitable equipment for the intended purpose is necessary. From a business perspective, the most problematic type of aggregation, as it may happen after the product has already been distributed in the marketplace, is that occurring throughout the shelf-life of biopharmaceuticals. This is an insidious process, often triggered by enzymatic degradation of constituents in the final product, which occurs slowly over time and can result in batch recalls, possible shortages of life-saving medicines, damage to the manufacturer's reputation, and financial loss. From a clinical viewpoint, the formation of particles in biopharmaceuticals may result in therapeutic activity loss and/or lead to unwanted immunogenic reactions if introduced into the body. It is mandatory to circumvent this problem as it can affect the quality parameters of the end product. If identified during the manufacturing process, in process control (IPC) and quality control (QC) measures are implemented in compliance with current good manufacturing practices (cGMP) to mitigate the likelihood of its occurrence. The purpose of this literature revision is to highlight specific manufacturing operations, alongside chemical and enzymatic occurrences that may lead to aggregation, and the preventative measures achieve mitigation.