Product Formulation

Achieving Stability Through Formulation Chemistry

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 analytical and computational tools for formulation design, and 3. Understanding the interplay between formulation and biotherapeutic characteristics to optimize stability. The various modalities of interest include large molecule protein and antibody therapeutics, vaccines, and cell and gene therapies.

Advancements in the Formulation of Biologics

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 & ultra high protein concentration strategies for protein products, alternative dosage form presentations (eg dried, suspensions, implants), enabling new routes of delivery, high throughput formulation development, use of AI and modeling, and overcoming clinical challenges to meet patient needs (eg multi-dose formulations, ambient stable, at home).