Therapeutic proteins have a propensity for aggregation during manufacturing, shipping, and
storage. The presence of aggregates in protein drug products can induce adverse immune …

Protein aggregation is one of the key challenges in the development of protein
biotherapeutics. It is a critical product quality issue as well as a potential safety concern due …

Protein aggregation in biotherapeutics has been identified to increase immunogenicity,
leading to immune-mediated adverse effects, such as severe allergic responses including …

Recombinant proteins are the mainstay of biopharmaceuticals. A key challenge in the
manufacturing and formulation of protein biologic products is the tendency for the active …

The elicitation of anti-drug antibodies (ADA) against biotherapeutics can have detrimental
effects on drug safety, efficacy, and pharmacokinetics. The immunogenicity of …

All protein therapeutics have the potential to be immunogenic. Several factors, including
patient characteristics, disease state, and the therapy itself, influence the generation of an …

Protein aggregates are one of the several risk factors for undesired immunogenicity of
biopharmaceuticals. However, it remains unclear which features determine whether …

The capacity of protein aggregates to enhance immune responses to the monomeric form of
the protein has been known for over a half-century. Despite the clear connection between …

Highlights•Proteins aggregate in a variety of ways, most of which are unwanted in drug
products.•Possible impacts on product quality include deliverability and immunogenicity.• …

Although it is well known that proteins are only marginally stable in their folded states, it is
often less well appreciated that most proteins are inherently aggregation-prone in their …