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References


BioPharm International


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.

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

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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.

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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.

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


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