at Purdue University
Opportunity Areas
The opportunity areas defined in this roadmap highlight resource allocation, collaboration, and prioritization of efforts needed to support technological advancements and achieve desired outcomes.
Product Formulation & Characterization
The distribution of new product modalities, such as mRNA, lipid nanoparticles (LNP), and cell and gene therapies, faces significant challenges due to the instability of these therapies at room temperature, necessitating costly cold storage and distribution. Developing stable, freeze-dried formulations for these advanced therapies requires extensive research to understand their solid-state behavior, as well as collaborative efforts between academia, industry, and regulatory bodies to create best practices. Additionally, innovations in analytical tools, drug delivery systems, and packaging will be highly valuable to support the development and patient access to these therapies.
Automation and Digitalization of Lyophilization
Advancements in drying processes in pharmaceutical manufacturing through the integration of automation, closed-loop controls, and digitalization will enhance process efficiency and product quality. The use of digital twins, wireless sensors, and cloud-based data storage can improve monitoring and prediction of equipment failures, optimize freeze-drying cycles, and support real-time quality assurance. Additionally, implementing advanced technologies such as VR/AR for remote maintenance and enhancing cybersecurity for cloud data storage are crucial steps for the future of automated and digitized lyophilization processes.
Freeze-Thaw Technologies
In lyophilization, the freeze-thaw process refers to the freezing and subsequent thawing of a substance, typically a biological or pharmaceutical material, before or during the drying process. Freeze-thaw directly impacts the stability, quality, and consistency of the product. Improper freezing or thawing can lead to stresses on the material, such as cryoconcentration, protein denaturation, and aggregation, especially in sensitive biologics like proteins or monoclonal antibodies. Understanding and optimizing freeze-thaw cycles helps maintain product integrity, prevent degradation, and ensure the final product meets quality standards during manufacturing and storage
Alternative Drying Technologies
Alternatives to vial freeze-drying, such as aseptic spray drying, spray freeze-drying, and spin freeze-drying, offer potential advantages in throughput or product homogeneity but are not widely adopted due to technological and logistical barriers. The COVID-19 pandemic highlighted the need for expanding lyophilization capacity, prompting exploration of these alternative techniques.