Development of stable lyophilized protein drug products

Current Pharmaceutical Biotechnology

Volumn 13, Issue 3, 2012, Pages 471-496

  Remmele, Richard L ^a   Krishnan, Sampathkumar ^c   Callahan, William J ^b  

^a MEDIMMUNE   (United States)

^b AMGEN INC   (United States)

^c Hospira Inc   (United States)

Author keywords

Analytical methods; Biopharmaceuticals; Excipients; Lyophilization; Proteins

Indexed keywords

ALBUMIN; ANTIOXIDANT; BUFFER; BULKING AGENT; EXCIPIENT; IMIGLUCERASE; IMMUNOGLOBULIN; MANNITOL; OMALIZUMAB; OVALBUMIN; PRESERVATIVE; RECOMBINANT BLOOD CLOTTING FACTOR 9; RECOMBINANT INTERLEUKIN 2; RECOMBINANT PROTEIN; RETEPLASE; SILICONE OIL; STABILIZING AGENT; SUCROSE; SURFACTANT; TENECTEPLASE; TRASTUZUMAB;

ANALYTIC METHOD; BRUNAUER, EMMETT AND TELLER METHOD; DRUG DEGRADATION; DRUG FORMULATION; DRUG PACKAGING; DRUG QUALITY; DRUG STABILITY; DRUG STORAGE; DRUG STRUCTURE; FOURIER TRANSFORM INFRARED PHOTOACOUSTIC SPECTROSCOPY; FREEZE DRYING; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; LYOPHILISATE; MASS SPECTROMETRY; MOISTURE; NONHUMAN; NUCLEAR MAGNETIC RESONANCE; PHOSPHORESCENCE; QUALITY CONTROL; RAMAN SPECTROMETRY; REVIEW; SILICONIZATION; STORAGE TEMPERATURE; SYRINGE; THERMOGRAVIMETRY; VISCOSITY; X RAY POWDER DIFFRACTION;

EID: 84857746385     PISSN: 13892010     EISSN: 18734316     Source Type: Journal    
DOI: 10.2174/138920112799361990     Document Type: Review

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