Therapeutic peptides and proteins

APPLICATION OF SIZE EXCLUSION-HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY FOR BIOPHARMACEUTICAL PROTEIN AND PEPTIDE THERAPEUTICS... 

The specification development process is a data-driven activity that requires a validated analytical method. The levels of data needed include assay precision, replicate process results (process precision), and real-time stability profiles. A statistical analysis of these data is critical in setting a realistic specification. Most often, aggregation and fragmentation degradation mechanisms are common to protein and peptide therapeutics. Therefore, the SE-HPLC method provides a critical quality parameter that would need to be controlled by a specification limit. 

Straub, J.O. (2010) Protein and peptide therapeuticals an example of benign by nature active pharmaceutical ingredients, in Green and Sustainable Pharmacy, (eds K. Kiimmerer and... 

These concerns largely preclude the utility of thermoplastic polymers as the primary choice of container closure system for protein and peptide therapeutics, although the formulation scientist should be aware of the potential advantages of these systems, such as the ease of manufacturability and their cost. These systems are also finding greater utility in intranasal and pulmonary delivery systems. 

Greater prevalence of protein and peptide therapeutic agents that cannot be readily crystallized. 

Clinical Applications and Challenges of Protein and Peptide Therapeutics... 

T.R.S. Kumar, K. Soppimath, S.K. Nachaegari, Novel delivery technologies fm protein and peptide therapeutics. Curr. Pharm. Biotech. 7, 261-276 (2006)... 

Maggio ET (2008) Novel excipients prevent aggregation in manufacturing and formulation of protein and peptide therapeutics. Bioprocess Int 6(10) 58-65... 

Protein and peptide therapeutics currently represent eight of the top 100 prescription pharmaceuticals in the U.S., and biotechnology products are projected to account for 15% of the total US. prescription drug market by 2003. Of the protein and peptide products now on the market, many are administered as daily injections, though several are delivered by noninvasive routes. For example, desmopressin is delivered as a nasal spray, and deoxyribonuclease I is administered by inhalation. Although cyclosporin A is orally active, as yet there are no general means to confer oral bioavailability to peptides and proteins. A major advance in delivery of peptides was achieved with the introduction of a monthly injectable, biodegradable microsphere formulation of LHRH. 

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