Biosimilars and Future Biotherapeutics

Formulation and Delivery Systems for Biologics

The formulation and delivery systems for biologics have evolved significantly over the past two decades, becoming a vital component in optimizing the efficacy, safety, stability, and patient experience of these complex therapies. Unlike small-molecule drugs, biologics such as monoclonal antibodies, fusion proteins, and therapeutic enzymes are large, fragile molecules produced using living cells. They are highly sensitive to environmental conditions and can degrade under stress, making their formulation and delivery particularly challenging. The primary goals in biologic formulation are to maintain structural integrity, prevent aggregation, ensure biological activity, and enable long-term stability. Achieving these goals requires the careful selection of excipients—such as buffers, surfactants, stabilizers, and preservatives—that support protein stability without introducing toxicity or immunogenicity. Advanced analytical tools are used during formulation development to monitor degradation pathways, including deamidation, oxidation, and aggregation, which can compromise therapeutic efficacy and safety. The formulation and delivery systems for biologics have evolved significantly over the past two decades, becoming a vital component in optimizing the efficacy, safety, stability, and patient experience of these complex therapies. Unlike small-molecule drugs, biologics such as monoclonal antibodies, fusion proteins, and therapeutic enzymes are large, fragile molecules produced using living cells.