• Journal of Microbiology and Biotechnology
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• v.12 no.6
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• pp.916-920
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• 2002

This report describes a high-level expression of human alpha-2a interferon ($IFN{\alpha}-2a$) in Escherichia coli and its pilot scale purification by using a monoclonal antibody-independent chromatographic procedure that is based on anion-exchange, cation-exchange, hydrophobic interaction, and gel filtration. The recombinant E. coli produced much more $IFN{\alpha}-2a$ in a soluble form, when cultivated at low temperatures than at high-temperature fermentation. However, if the bacterial growth was taken into consideration, fermentation at $30^{\circ}C$ seemed optimal for the interferon production. By using our new protocol, we recovered approximately 160 mg of $IFN{\alpha}-2a$ with a specific activity of $3.59{\times}10^8$ IU/mg from 201 of the broth. The gel permeation chromatographic and SDS-PAGE indicated that the interferon preparation was purified to homogeneity and was of the correctly folded fast-migrating monomer.

• Toxicological Research
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• v.9 no.1
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• pp.119-123
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• 1993

LBD-007, a newly developed recombinant human interferon ${\alpha}$A, was tested for primary eye and skin irritation in male New Zealand White rabbits. In the primary eye irritation test, 0.1ml of a solution of LBD-007 was instilled into the eye. In rinsing group, the eye was washed with water 30 seconds after instillation. No reaction was observed at the cornea, iris and conjunctivae by LBD-007. In the primary skin irritation test, LBD-007 was applied to the back of rabbits for 24 hours. Primary irritation index was "0" in test and control sites of all animals. Thus LBD-007 was evaluated as a non-irritant on the basis of the criteria of Draize et al.,(1994).

• Toxicological Research
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• v.9 no.1
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• pp.99-105
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• 1993

LBD-007, a newly developed recombinant human interferon alphaA, was at dose levels of 0.3 $\times$$10^6$ , 6 $\times$ $10^6$ and 12 $\times$ $10^6$ IU/kg/day administered subcutaneously to pregnant New Zealand White rabbits during the organogenetic period. Cyclophosphamide was used as a positive control. All pregnant females were subjected to the caesarean section on day 28 of pregnancy. Effect of test substance on dams and embryonal development of fetuses were examined. 1. No treatment-related changes in clinical signs, food consuption, body weight and necropsy findings of dams were observed.

• Toxicological Research
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• v.9 no.1
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• pp.107-118
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• 1993

LBD-007, a newly developed recombinant human interferon alphaA, was at dose levels of 0.3 $\times$$10^6$ , 6 $\times$ $10^6$ and 12 $\times$ $10^6$ IU/kg/day administered subcutaneously to pregnant and subsequent delivered SpragueDawley rats from day 17 of gestation through day 21 of lactation. Effects of test substance on dams and growth, behaviour and mating performance of F1 offspring were examined. 1. No treatmene-related changes in clinical signs, food consumption, body weight, pregnant period and necropsy findings were observed in dams.

• Toxicological Research
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• v.9 no.1
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• pp.73-82
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• 1993

LBD-007, a newly developed recombinant human interferon alphaA, was at dose levels of 0, 3$\times$$10^6$, 6$\times$ $10^6$ and 12$\times$1$10^6$ IU/kg/day administered subcutaneously to Sprague-Dawley male rats from premating to mating period and to females from premating to early gestation period. Effects of test agent on reproductive performance of both sexes and embryonic development were examined. 1. No treatment-relared changes in food consumption, body weight and necropsy findings were observed in parent animals.

• KSBB Journal
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• v.32 no.1
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• pp.16-21
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• 2017

The multiple sclerosis caused by multiple inflammatory disease or immune system disorder, is usually treated by interferon ${\beta}$ through adjusting the abnormal immune reactions. For high production of human interferon ${\beta}$ using recombinant E. coli, codon optimized and wild type genes were synthesized. When pET-15b or pET-21a vector was used as an expression vector with each gene, there was no target protein expression. When pQE30 vector was used as an expression vector, human interferon ${\beta}$ was expressed by recombinant E. coli XL1-blue and E. coli JM109. Using the codon optimized gene, the expression of human interferon ${\beta}$ was slightly increased as compared to that from wild type gene. However, most of expressed human interferon ${\beta}$ was insoluble form.

• Biomolecules & Therapeutics
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• v.1 no.2
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• pp.266-269
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• 1993

The acute toxicity of a recombinant human interferon $\alpha$A (code name: LBD-007) was evaluated in both sexes of ICR mice, 5 weeks old, by the oral, subcutaneous and intravenous routes of administration. Based on the results, LBD-007 was not considered to induce any toxic effect on the mice in mortalities, clinical findigs, body weights and gross findings. It is suggested that LD$_{50}$ values in mice would be $>48{\times}10^8$ IU/kg in the oral, subcutaneous or intravenous routes.s.

• Toxicological Research
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• v.9 no.1
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• pp.83-98
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• 1993

LBD-007, a newly developed recombinant human interferon alpha A, was at dose levels of 0, 3 $\times$ $10^6$, 6 $\times$ $10^6$ and 12 $\times$ $10^6$ IU/kg/day administered subctaneously to pregnant Sprague-Dawley rats during the organogenetic period. Ethylenethiourea was used as a positive control. 2/3 of dams per group were subjected to caesarean section on day 20 of pregnancy and the remaining 10 dams per group were allowed to deliver. Effects of test substance on dams, embryonal development development of F1 fetuses, as well as growth, behaviour and mating performance of F1 offspring were examined. 1. No treatment-related changes in clinical signs, food consumption, body weight and necropsy findings of dams were observed.

• Toxicological Research
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• v.12 no.1
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• pp.87-91
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• 1996

LB00013, a newly developed recombinant human Interferon $\beta$, was tested for primary eye and skin irritation in male New Zealand White rabbits. In the primary eye irritation test, 0.1 ml of a solution of LB00013 was instilled into the eye. In the rinsing group, the eye was washed with water at 30 seconds after instillation. No reaction was produced at the cornea, iris and conjunctivae by LB00013. In the primary skin irritation test, LB00013 was applied to the back of rabbits for 24 hours. Primary irritation index was "0" in test and control sites of all animals. Thus LB00013 was evaluated as a non-irritant on the basis of the criteria of Draize et al. (1944).l. (1944).

• Toxicological Research
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• v.13 no.1_2
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• pp.167-173
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• 1997

LBD-001, a recombinant human interferon $\gamma$ produced by genetically engineered yeast as a host system, was intravenously administered to pregnant female rabbits (New Zealand White strain) from day 6 to 18 of gestation at dose levels of $0.35 \times 10^6$, $0. 69 \times 10^6$, and $1.38 \times 10^6$ I.U./kg/day. Hydrocortisone sodium succinate (0.3 mg/kg/day) was also given in the same way. Teratological effects of the test agents on the organogenesis of fetuses and the development of offsprings (F1 rabbits) were investigated. The results were as followings: (1) No significant changes by the treatment of LBD-001 or hydrocortisone sodium succinate were observed in the body weights, the food and water consumption, the lactating or nurshing behaviors, and the autopsy of the pregnant rabbits. (2) No significant changes in the resorption rate, the fetal organogenesis, and the normal develpoment of offsprings (F1) by the treatment of LBD-001 or hydrocortisone sodium succinate were detected. The results show that LBD-001 at the dose of $1.38 \times 10^6$ I.U./kg/day or less and hydrocortisone sodium succinate at the dose of 0.3 mg/kg/day are neither teratogenic in the organogensis of the fetuses and the development of the offsprings (F1) nor toxic to the mother rabbits.