Product Formulation

Three sessions are available for abstract submission.

Unlocking Biotherapeutic Drug Stability Using Formulation Science

Biotechnology thrives on innovation in clinical applications, but ensuring the long-term stability of biotherapeutics remains a critical hurdle. This session delves into the exciting world of formulation science by exploring how formulation decisions and mechanistic insights can be harnessed to unlock the superior stability of drug solutions. Key areas of interest include: 1. Utilizing novel excipients and delivery systems to enhance stability at patient-centric storage conditions, 2. Leveraging computational tools for formulation design, and 3. Understanding the interplay between formulation and biotherapeutic characteristics to optimize stability. The various modalities of interest include protein and antibody therapeutics, vaccines, and cell and gene therapies.

Stability and formulating of new modalities

Recent years have seen significant and successful development of RNA and cell transfection modalities that aspire to cure a wide array of unmet and putatively undruggable diseases. While some of these products have gained regulatory approval, substantial work is needed to understand the boundary between the individual and this new class of medicines to produce optimal efficacy and safety profiles. 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 formulation/process control to minimize impact of biologically variable inputs, such as cellular product quality or enzymes. The structure, dynamics, and kinetics of in vivo stability of these structures also represents a key consideration that must be accounted for during product development. This session invites abstracts involving formulation, stability optimization (in vitro or in vivo) 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.

Advancements in the Formulation of Biologics: from Lab to Market

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.