BioMAN Workshop on Process Intensification: Downstream, Formulation and Product Development

Process intensification in biomanufacturing has been driven by improved technologies as well as growing patient demand for both traditional biotherapeutics and novel modalities. Intensified processes can provide higher yields and improved product quality while requiring less space, energy, and time than conventional processes. Upstream intensification has achieved highly productive cell lines and high-titer modes of production culture. Unlocking the full value of intensified processes requires additional technological and operational innovation in other parts of the process. Our fall workshop, Process Intensification: Downstream, Formulation and Product Development, will explore innovations in the downstream manufacturing processes and throughout the drug development pipeline.

Topic 1: Intensified Separation Technologies for Proteins, Vaccines, and Viral Vectors

Intensified purification technologies can enable fully continuous processes, accelerate turnaround times, and maximize yields. This topic will focus on the innovations and improvements in separation technology which are enabling this intensification. These may include: more cost-effective resins and column configurations for chromatography, alternative separation technologies such as crystallization, improved purification for virions and novel proteins, and development of continuous downstream process flows.

Topic 2: Intensified Drug Formulation and Presentation

Intensified formulation and fill/finish are the bridge between intensified process productivity and widespread therapeutic availability. To meet the needs of a rapidly expanding patient population as well as new therapeutic modalities, improved stability and administrability must advance with production technology. This topic will discuss advances in formulation, container, and packaging technology intended to meet these challenges. Industry needs include: formulations for mRNA vaccines, delivering drugs outside the cold chain, easily injectable high-concentration formulations, lyophilization solutions for continuous manufacturing, and advances in the design and application of glass vials.

Topic 3: Intensified Product Development

In addition to providing cost savings and productivity increases, intensification can be used to shorten drug development timelines, de-risk process development, and better integrate all parts of the drug discovery and development process. This topic will explore how intensification can be applied from drug discovery through commercialization, for proteins, vaccines and ATMPs. Examples of this might be: high-throughput cell line selection, parallel license applications alongside process development, and rapid production of pilot material.