Product Formulation
Advancements in the Formulation of Biologics: from Lab to Market
Wednesday 3/20/2024, 8:00 -11:00 AM
The formulation of biologics provides opportunities and challenges for scientific and technological advancement. From the fundamentals of protein chemistry to the development of patient-centric presentations, these opportunities can be modality specific or span the range from monoclonal antibodies to fusion proteins to antibody drug conjugates to bispecifics, and beyond. Subjects in this area include, but are not limited to, high-dose strategies for protein products, improving protein stability and desiccation tolerance, strategies for developing biosimilar products, and overcoming clinical challenges to meet patient needs.
Enabling Drug Products for Novel Modalities
Thursday 3/21/2024, 8:00 -11:00 AM
Therapies based on new modalities such as mRNA/siRNA and cells offer hope for treatment of a wide array of diseases, including ones previously considered incurable, and support approaching undruggable targets. Recent years have seen a significant rise in the successful development of these new modalities and while some of these products have gained regulatory approval, substantial opportunities exist for continued maturation of formulation and drug product manufacturing process technology strategies. Unlike conventional therapeutic protein or monoclonal antibody technologies, platform processes for these therapies are still in their infancy and are indeed more challenging due to the increased complexity of these systems. Some major challenges are RNA and lipid nanoparticle (LNP) stability (liquid or frozen), interfacial sensitivities, drug product configuration aligned with supply chain and user needs, scale up technologies for RNA therapies, and for cell-based therapies they are formulation and storage, and process control to minimize impact on cellular product quality. This session invites abstracts involving formulation, stability optimization and drug product presentations for new modalities such as RNA LNPs and cell therapy. Further, abstracts involving advances in the drug product platform process development and characterization, and overall control strategy for these new modalities are also encouraged.