The optimization of upstream and downstream processes for production of recombinant
adeno-associated virus (rAAV) with consistent quality depends on the ability to rapidly …

Protein aggregation has been recognized as one of the major challenges in the
development and commercialization of successful protein-based drug products because of …

Based on its clinical benefits, Trikafta—the combination of folding correctors VX-661
(tezacaftor), VX-445 (elexacaftor), and the gating potentiator VX-770 (ivacaftor)—was FDA …

Antibody-based proteins have become an important class of biologic therapeutics, due in
large part to the stability, specificity, and adaptability of the antibody framework. Indeed …

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

In recent years, the use and number of biotherapeutics has increased significantly. For these
largely protein-based therapies, the quantitation of aggregates is of particular concern given …

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 …

Bone morphogenetic proteins (BMPs) are responsible for bone formation during
embryogenesis and bone regeneration and remodeling. The osteoinductive action of BMPs …

Fc‐Fusion proteins represent a successful class of biopharmaceutical products, with already
13 drugs approved in the European Union and United States as well as three biosimilar …