Development and characterization of a lyophilized dosage form of IL-1 beta.
The development and characterization of a lyophilized dosage form for recombinant Interleukin-1 beta is described. Included in the evaluation of the drug product are accelerated and long-term stability studies utilizing a number of biophysical techniques (reverse-phase HPLC, SDS-PAGE, isoelectric focusing and ELISA). Data collected with these methods were examined for correlations with biological activity assessments provided by an in-vitro cell culture system (mouse thymocyte proliferation). Results of these studies demonstrate that a lyophilized dosage form of Interleukin-1 beta can be prepared which retains its potency for at least 1 year when stored at ambient temperature. The analytical methodology used to assess the physicochemical integrity of the protein provided a sensitive and reproducible means of predicting changes in biological activity.
Visor
G C
GC
Institute of Pharmaceutical Sciences, Syntex Research, Palo Alto, Ca.
Tsai
K P
KP
Miller
M D
MD
Duffy
J
J
Calderwood
T
T
Lokensgard
D
D
Killian
J
J
Malefyt
T
T
Gu
L
L
Massey
I
I
D000818:Animals; D001681:Biological Assay; D004304:Dosage Forms; D004355:Drug Stability; D005612:Freeze Drying; D066298:In Vitro Techniques; D007275:Injections, Intravenous; D007375:Interleukin-1 / Q000008:administration & dosage* / Q000302:isolation & purification; D008213:Lymphocyte Activation; D051379:Mice; D013601:T-Lymphocytes / Q000276:immunology; D013696:Temperature
D004304:Dosage Forms; D007375:Interleukin-1