10/13/2023
By Fanglin Che
Lyophilization of Biopharmaceuticals: Opportunities, Challenges and Regulatory Perspectives
Maxwell Korang-Yeboah, Senior Research Scientist, DPQR/OTR/OPQ/CDER, US Food and Drug Administration
Abstract:
Lyophilization, also known as freeze-drying, is a complex process that couples heat and mass transfer for improving the shelf life of moisture labile pharmaceuticals and biopharmaceuticals. The recent challenges of storing and transporting mRNA vaccines in the solution state have further highlighted the value of aseptic drying techniques such as lyophilization in the pharmaceutical industry. While there has been some progress in the adoption of modern process analytical technology (PAT) and emerging technology such as continuous manufacturing in the manufacturing of solid oral dosage forms, there has been very little innovation in freeze-drying of biopharmaceuticals at manufacturing scale. This presentation will highlight efforts by FDA in addressing scientific and technical challenges to modernizing lyophilization and encouraging the adoption of emerging technology for lyophilization. Further, case studies highlighting the role of internal OTR/OPQ research in advancing innovation in lyophilization and addressing regulatory challenges will be highlighted. Finally, we will discuss potential training and collaboration opportunities.
Bios: Maxwell Korang-Yeboah, Ph.D. is a Senior regulatory research scientist in the Division of Product Quality Research/ Office of Testing and Research/OPQ/CDER/FDA. He serves as lead in regulatory research in lyophilization, complex drug products and characterization of peptides and proteins geared at advancing the scientific basis of review, policy, and guidance development. In addition, Maxwell serves as a subject matter expert in support of regulatory review, adoption of emerging technologies and risk assessment of freeze drying/lyophilization. He is a member of OPQ’s Center of Excellence for Manufacturing Science and a subject matter expert for CDER’s Emerging Technology team. He is a recipient of a dozen FDA, CDER and OPQ regulatory research honor awards for his research contributions to the mission of the Agency. Maxwell is a well published scientist and has presented his work at several national and international scientific conferences and workshops. Maxwell holds a Ph.D. in Pharmaceutical Sciences from Mercer University, Atlanta, GA.
If you have any questions or concerns, please reach out to fanglin_che@uml.edu.