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

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 …

Microneedles have been used for the dermal and transdermal delivery of a broad range of
drugs, such as small molecular weight drugs, oligonucleotides, DNA, peptides, proteins and …

Biologics such as monoclonal antibodies are much more complex than small-molecule
drugs, which raises challenging questions for the development and regulatory evaluation of …

ABSTRACT Within the European Immunogenicity Platform (EIP)(http://www. eip. eu), the
Protein Characterization Subcommittee (EIP-PCS) has been established to discuss and …

Transdermal delivery provides numerous benefits over conventional routes of
administration. However, this strategy is generally limited to a few molecules with specific …

A host of diverse stress techniques was applied to a monoclonal antibody (IgG 2) to yield
protein particles with varying attributes and morphologies. Aggregated solutions were …

Background: Aggregated biotherapeutics have the potential to induce an immune response.
Results: Aggregates can enhance innate and adaptive immune responses of PBMC …

Biologic products encounter various types of interfacial stress during development,
manufacturing, and clinical administration. When proteins come in contact with vapor–liquid …

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 …