Subcutaneous formulations are developed based on the science of pharmaceutical drug formulations and empirically detected biological behavior. What are "golden rules" to develop a general "best in class approach for subcutaneous formulations to inject a new biologic (antibody, antibody-drug conjugates or vaccines) into the "biological compartment"?
Krishnan Umachandran
small molecules medium molecules large molecules biopolymers built from amino acids, nucleotides, saccharides Conjugates of large molecules with medium size (CovX) or small molecules (PEG) Small molecules are made by well understood and controlled chemical synthesis Proteins (including antibodies) are made by less controlled fermentation Cell components Cells or tissues Peptides and oligonucleotides fall under NDA Proteins and antibodies Enzyme Antibodies Hormones
Broad variety of attributes:
• Molecular Weight (MW):
• Chemistries and the level of structural complexity:
• Manufacturing or source of the material:
• Regulatory cutoff in the US (may be different in other countries):
• Functional class
• Others
http://www.usp.org/sites/default/files/usp_pdf/EN/meetings/workshops/0120101208psawsday1master.pdf
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