Conventional protein production systems have enabled the growth of the biopharmaceutical industry, offering established manufacturing processes and regulatory pathways. However, reproducing the structural complexity and biological characteristics of native human proteins remains a significant challenge. The following figure summarizes four key challenges facing the biopharmaceutical industry.
Next-generation biopharmaceuticals require a new production platform that combines human-specific protein characteristics with practical productivity, scalability, and faster development.
Difficulty Reproducing Human PTMs
Conventional non-human expression systems struggle to faithfully reproduce native human glycosylation, lipid modifications, and protein folding.
Difficult Expression of Complex Proteins
Multi-chain proteins, membrane proteins, and multi-subunit complexes present significant challenges in expression and proper assembly.
Long Development Timelines
Protein-specific cloning, cell-line selection and establishment, and cell-bank construction prolong development timelines.
Human-Cell Manufacturing Challenges
Human-cell manufacturing requires further advances in productivity, scale-up, cost efficiency, and regulatory compliance.