Group Leader - Senior Principal Scientist Pfizer, Inc. Lexington, Massachusetts
The development of protein therapeutics with high concentration and stability is a key challenge for the biopharmaceutical industry. The advent of new protein modalities that range from bispecifics (biTe, bispecific mAb), trispecifics, tetrafab has also increased the technical challenges since the structural and molecule understanding, and experience is starting to build up. High concentration formulations are desirable for several reasons, such as reducing the injection volume, improving patient compliance, and enabling alternative delivery routes. However, high concentration also poses significant challenges for the formulation, drug substance and drug product manufacturing processes, and delivery of protein drugs. The common pitfalls associated with development of biologics include increased viscosity, protein aggregation and precipitation, and subvisible particle formation. These challenges can affect the quality, safety, efficacy, and manufacturability of the products, and require careful consideration of the physico-chemical properties of the protein, the formulation components, the process parameters, and the delivery device.
The symposium aims to provide an overview of the current state-of-the-art in high concentration protein formulation development, compare current understanding of new protein modalities and difficulty vs ease of development, and to showcase the latest advances in analytical, biophysical, and in-silico tools and strategies that can facilitate and accelerate the development of high concentration protein products. The symposium will also connect these to delivery challenges and especially in the development of drug delivery devices (prefilled syringe, autoinjectors, on body delivery systems, etc.).
Learning Objectives:
Review the challenges and opportunities in developing high concentration protein formulations, processes, and delivery systems.
Highlight recent advances in experimental and computational methods for predicting and overcoming high concentration liabilities and showcase best practices and case studies in high concentration protein formulation development and optimization.
Foster the exchange of knowledge and experience among academic and industry researchers, and to identify the knowledge gaps and future directions in the field.
