Protein stability |
Formulation optimization, stabilizers, protein engineering for enhanced stability |
Immunogenicity |
Protein engineering to reduce immunogenic epitopes, immunomodulatory agents |
Delivery and targeting |
Advanced delivery systems (nanoparticles, liposomes), specific targeting methods |
Production costs |
Advances in biotechnology, improved manufacturing processes |
Dosing precision |
Tailoring dosages, controlled-release systems for precision |
Regulatory hurdles |
Clear documentation, rigorous testing to meet regulatory standards |
Short half-life |
Modification (e.g., PEGylation) to extend the therapeutic effect, altering formulation |
Storage and handling |
Proper storage conditions, suitable packaging for preservation |