References

Jul 31, 2004

ARTICLESBiopharmaceutical Process Extractables Core Team. Evaluation of extractables from product-contact surfaces. BioPharm International 2002; 15(12):22-34.

Chi EY, Krishnan S, Randolph TW, Carpenter JF. Physical stability of proteins in aqueous solution: mechanism and driving forces in nonnative protein aggregation. Pharm Res 2003; 20(9):1325-1336.

Cleland JL, Powell MF, Shire SJ. The development of stable protein formulations: a close look at protein aggregation, deamidation, and oxidation. Crit Rev Ther Drug Carrier Syst 1993; 10:307-377.

Crowe JH, Crowe LM, Carpenter JF. Preserving dry biomaterials: the water replacement hypothesis, part 1. BioPharm 1993; 6(3):28.

Crowe JH, Crowe LM, Carpenter JF. Preserving dry biomaterials: the water replacement hypothesis, part 2. BioPharm 1993; 6(4):40.

Faulkner J. The evolving role of product characterization during development.BioPharm 2000; 13(6):26.

Franks F, Hatley RHM, Mathias SF. Materials science and the production of shelf-stable biologicals. BioPharm 1991; 4(8):38.

Imensek M. Sterile fill facilities: problems and resolutions. BioPharm International 2003; 16(9):44-54.

Katre N. Lipid-based multivesicular carriers for sustained delivery of therapeutic proteins and peptides. BioPharm International 2001; 14(3 supplement):8.

Kerr AP, et al. An early warning tool for pharmaceutical development. BioPharm 1992; 5(2):24.

Kleinert HD, Baker WR, Stein HH. Orally bioavailable peptidelike molecules: a case history. BioPharm 1993; 6(1):36.

Krishnamurthy R. Protein stability in pulmonary delivery formulations: a review. BioPharm 1999; 12(3):34.

Krishnamurthy R, Manning MC. The stability factor: importance in formulation development. Curr Pharm Biotech 2002; 3:361-371.

Lakings DB. Making a successful transition from drug discovery to drug development, part 1. BioPharm 1995; 8(7):20.

Lee VHL. Oral route of peptide and protein drug delivery. BioPharm 1992; 5(5):39.

Lee VHL. Trends in peptide and protein drug delivery. BioPharm1991; 4(2):22.

Lee WA, Longenecker JP. Intranasal delivery of proteins and peptides. BioPharm 1988; 1(3):30.

Lee WA. Permeation enhancers for the nasal delivery of protein and peptide therapeutics. BioPharm 1990; 3(9):22.

Patapoff TW, Overcashier DE. The importance of freezing on lyophilization cycle development. BioPharm 2002; 15(3):16-21, 72.

Pelegrin M, et al. Encapsulated antibody-producing cells for long-term passive immunotherapy. BioPharm 1999; 12(10):32.

Pikal MJ. Freeze-drying of proteins, part 2: formulation selection. BioPharm 1990; 3(8):26.

Roser B. Trehalose drying: a novel replacement for freeze-drying. BioPharm 1991; 4(7):47.

Sanghvi P, Banakar UV. Ultrasonics: principles and biomedical applications. BioPharm 1991; 4(7):32.

Schmidt DJ, Akers MJ. Cryogranulation: a potential new final process for bulk drug substances. BioPharm 1997; 10(4):28.

Scott C. Formulation case studies: a tutorial. BioPharm 2001; 14(8):34-35.

Strattan CE. Cyclodextrins and biological macromolecules. BioPharm 1991; 4(9):44.

Talsma H, Crommelin DJA. Liposomes as drug delivery systems, part 2: characterization. BioPharm 1992; 5(9):38.

Talsma H, Crommelin DJA. Liposomes as drug delivery systems, part 3: stabilization. BioPharm 1993; 6(2):40.

Webb SD, Webb JN, Hughes TG, Sesin DF, Kincaid AC. Freezing bulk-scale biopharmaceuticals using common techniques — and the magnitude of freeze-concentration. BioPharm 2002; 15(5):22-34.

Weiner AL. Developing lipid-based vehicles for peptide and protein drugs. BioPharm 1990; 3(2):27.

Weiner AL. Lipid-based vehicles for peptide and protein drugs, part 2: manufacturing variables. BioPharm 1990; 3(3):16.