RU2001126396A - SET FOR RADIOACTIVE LABELING OF PROTEINS ITTREM-90 - Google Patents

SET FOR RADIOACTIVE LABELING OF PROTEINS ITTREM-90

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Publication number
RU2001126396A
RU2001126396A RU2001126396/04A RU2001126396A RU2001126396A RU 2001126396 A RU2001126396 A RU 2001126396A RU 2001126396/04 A RU2001126396/04 A RU 2001126396/04A RU 2001126396 A RU2001126396 A RU 2001126396A RU 2001126396 A RU2001126396 A RU 2001126396A
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RU
Russia
Prior art keywords
kit
buffer
chelator
dtpa
radioisotope
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RU2001126396/04A
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Russian (ru)
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RU2221807C2 (en
Inventor
Пол ЧИНН
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Айдек Фармасьютикалз Корпорейшн
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Claims (48)

1. Способ радиоактивного мечения конъюгированного с хелатором белка или пептида терапевтическим радиоактивным изотопом для введения пациенту, заключающийся в том, что смешивают конъюгированный с хелатором белок или пептид с раствором, содержащим радиоактивный изотоп или его соль, и инкубируют эту смесь в течение достаточного количества времени при подходящих условиях, при этом образуется радиоактивно меченый белок или пептид, имеющий достаточные чистоту, удельную активность и специфичность связывания, так что полученное радиоактивно меченое антитело может вводиться непосредственно пациенту без дополнительной очистки.1. A method for radiolabelling a chelator-conjugated protein or peptide with a therapeutic radioactive isotope for administration to a patient, the method is that the chelator-conjugated protein or peptide is mixed with a solution containing the radioactive isotope or its salt, and the mixture is incubated for a sufficient amount of time at under suitable conditions, a radioactively labeled protein or peptide is formed having sufficient purity, specific activity and binding specificity, so that the resulting radioactively labeled antibody can be administered directly to the patient without further purification. 2. Способ по п.1, в котором указанный терапевтический радиоизотоп выбирают из группы, состоящей из альфа- и бета-излучателей.2. The method according to claim 1, wherein said therapeutic radioisotope is selected from the group consisting of alpha and beta emitters. 3. Способ по п.2, в котором в качестве указанного радиоизотопа используют бета-излучатель.3. The method according to claim 2, in which a beta emitter is used as the specified radioisotope. 4. Способ по п.3, в котором указанный бета-излучатель представляет собой 90Y.4. The method according to claim 3, wherein said beta emitter is 90 Y. 5. Способ по п.1, в котором указанный белок является антителом или фрагментом антитела.5. The method according to claim 1, wherein said protein is an antibody or antibody fragment. 6. Способ по п.4, в котором указанное достаточное время инкубации составляет менее восьми минут.6. The method according to claim 4, in which the indicated sufficient incubation time is less than eight minutes. 7. Способ по п.6, в котором указанное достаточное время инкубации находится в пределах от около двух до около пяти минут.7. The method according to claim 6, in which the specified sufficient incubation time is in the range from about two to about five minutes. 8. Способ по п.1, в котором используют хелатор, являющийся бифункциональным хелатором, выбранным из группы, состоящей из MX-DTPA, фенил-DTPA, бензил-DTPA, CHX-DTPA, DOTA и их производных.8. The method according to claim 1, wherein a chelator is used, which is a bifunctional chelator selected from the group consisting of MX-DTPA, phenyl-DTPA, benzyl-DTPA, CHX-DTPA, DOTA and their derivatives. 9. Способ по п.8, в котором указанный хелатор представляет собой MX-DTPA.9. The method of claim 8, wherein said chelator is MX-DTPA. 10. Способ по п.4, в котором в качестве подходящих условий рассматривают приемлемые условия температуры, рН и буфера.10. The method according to claim 4, in which suitable conditions are considered acceptable conditions of temperature, pH and buffer. 11. Способ по п.10, в котором указанная приемлемая температура находится в диапазоне от около 25 до около 43°С.11. The method according to claim 10, in which the specified acceptable temperature is in the range from about 25 to about 43 ° C. 12. Способ по п.10, в котором указанная приемлемая величина рН находится в диапазоне от около 3,0 до около 6,0.12. The method according to claim 10, in which the specified acceptable pH is in the range from about 3.0 to about 6.0. 13. Способ по п.10, в котором указанный приемлемый буфер является ацетатным буфером.13. The method of claim 10, wherein said acceptable buffer is an acetate buffer. 14. Способ по п.13, в котором указанный буфер является ацетатом натрия и присутствует в концентрации от около 10 до около 1000 мМ.14. The method according to item 13, in which the specified buffer is sodium acetate and is present in a concentration of from about 10 to about 1000 mm. 15. Способ по п.10, в котором указанный приемлемый буфер содержит мягкий радиопротектор.15. The method of claim 10, wherein said acceptable buffer comprises a soft radioprotector. 16. Способ по п.15, в котором в качестве мягкого радиопротектора используют аскорбат.16. The method according to clause 15, in which ascorbate is used as a soft radioprotector. 17. Способ по п.1, в котором достигают уровень включения радиоизотопа по меньшей мере приблизительно 95%.17. The method according to claim 1, wherein the radioisotope incorporation level of at least about 95% is achieved. 18. Способ по п.1, в котором специфичность связывания равна по меньшей мере 70%.18. The method according to claim 1, in which the specificity of the binding is at least 70%. 19. Способ по п.5, в котором используют антитело, являющееся меченым до удельной активности по меньшей мере 5 мКи/мг.19. The method according to claim 5, in which an antibody is used that is labeled to a specific activity of at least 5 mCi / mg. 20. Набор для радиоактивного мечения конъюгированного с хелатором белка или пептида терапевтическим радиоактивным изотопом для введения пациенту, содержащий флакон, содержащий конъюгированный с хелатором белок или пептид в подходящем буфере, флакон, содержащий буфер композиции для стабилизации и введения радиоактивно меченого антитела пациенту, и инструкции для проведения процедуры радиоактивного мечения, при которой конъюгированный с хелатором белок или пептид экспонируется радиоизотопу или его соли в течение достаточного количества времени при подходящих условиях, рекомендуемых в указанных инструкциях, с получением радиоактивно меченого белка или пептида, имеющего достаточные чистоту, удельную активность и специфичность связывания, так что полученное радиоактивно меченое антитело подвергается разведению до подходящей концентрации в указанном буфере композиции и введению непосредственно пациенту без дополнительной очистки.20. A kit for radiolabeling a chelator-conjugated protein or peptide with a therapeutic radioactive isotope for administration to a patient, comprising a vial containing a chelator-conjugated protein or peptide in a suitable buffer, a vial containing a composition buffer for stabilizing and administering a radiolabeled antibody to a patient, and instructions for a radiolabeling procedure in which a chelator-conjugated protein or peptide is exposed to a radioisotope or its salt for a sufficient amount at appropriate conditions recommended in these instructions, to obtain a radiolabeled protein or peptide having sufficient purity, specific activity and binding specificity, so that the resulting radiolabeled antibody is diluted to a suitable concentration in the indicated buffer of the composition and administered directly to the patient without additional cleaning up. 21. Набор по п.20, в котором указанный терапевтический радиоизотоп является альфа- или бета-излучающим радиоизотопом.21. The kit of claim 20, wherein said therapeutic radioisotope is an alpha or beta emitting radioisotope. 22. Набор по п.21, в котором указанный терапевтический радиоизотоп является бета-излучателем.22. The kit of claim 21, wherein said therapeutic radioisotope is a beta emitter. 23. Набор по п.22, в котором указанный бета-излучатель является 90Y.23. The kit of claim 22, wherein said beta emitter is 90 Y. 24. Набор по п.20, в котором указанный белок является антителом или фрагментом антитела.24. The kit of claim 20, wherein said protein is an antibody or antibody fragment. 25. Набор по п.23, в котором указанное достаточное время инкубации составляет менее восьми минут.25. The kit of claim 23, wherein said sufficient incubation time is less than eight minutes. 26. Набор по п.25, в котором указанное достаточное время инкубации находится в пределах от около двух до около пяти минут.26. The kit of claim 25, wherein said sufficient incubation time is in the range of about two to about five minutes. 27. Набор по п.20, в котором указанный хелатор является бифункциональным хелатором, выбранным из группы, состоящей из MX-DTPA, фенил-DTPA, бензил-DTPA, CHX-DTPA, DOTA и их производных.27. The kit of claim 20, wherein said chelator is a bifunctional chelator selected from the group consisting of MX-DTPA, phenyl-DTPA, benzyl-DTPA, CHX-DTPA, DOTA and derivatives thereof. 28. Набор по п.27, в котором указанный хелатор представляет собой MX-DTPA.28. The kit of claim 27, wherein said chelator is MX-DTPA. 29. Набор по п.20, в котором указанные подходящие условия обозначают приемлемые условия температуры, рН и буфера.29. The kit of claim 20, wherein said suitable conditions indicate acceptable conditions of temperature, pH, and buffer. 30. Набор по п.29, в котором указанная приемлемая температура находится в диапазоне от около 25 до около 43°С.30. The kit according to clause 29, in which the specified acceptable temperature is in the range from about 25 to about 43 ° C. 31. Набор по п.29, в котором указанная приемлемая величина рН находится в диапазоне от приблизительно 3,0 до приблизительно 6,0.31. The kit according to clause 29, in which the specified acceptable pH is in the range from about 3.0 to about 6.0. 32. Набор по п.29, в котором указанный приемлемый буфер является ацетатным буфером.32. The kit according to clause 29, wherein said acceptable buffer is an acetate buffer. 33. Набор по п.32, в котором указанный буфер является ацетатом натрия и присутствует в концентрации от около 10 до около 1000 мМ.33. The kit of claim 32, wherein said buffer is sodium acetate and is present in a concentration of from about 10 to about 1000 mM. 34. Набор по п.29, в котором указанный приемлемый буфер содержит мягкий радиопротектор.34. The kit according to clause 29, in which the specified acceptable buffer contains a soft radioprotector. 35. Набор по п.34, в котором мягким радиопротектором является аскорбат.35. The kit according to clause 34, in which the soft radioprotector is ascorbate. 36. Набор по п.20, в котором достигается уровень включения радиоизотопа по меньшей мере приблизительно 95%.36. The kit of claim 20, wherein the radioisotope incorporation level of at least about 95% is achieved. 37. Набор по п.20, в котором специфичность связывания равна по меньшей мере 70%.37. The kit of claim 20, wherein the binding specificity is at least 70%. 38. Набор по п.23, в котором антитело является меченым до удельной активности по меньшей мере 5 мКи/мг.38. The kit of claim 23, wherein the antibody is labeled to a specific activity of at least 5 mCi / mg. 39. Набор по п.20, который дополнительно содержит флакон стерильного буфера для коррекции рН радиоизотопа.39. The kit according to claim 20, which further comprises a bottle of sterile buffer for adjusting the pH of the radioisotope. 40. Набор по п.39, в котором указанный флакон содержит ацетатный буфер.40. The kit of claim 39, wherein said vial contains acetate buffer. 41. Набор по п.20, в котором указанный буфер композиции содержит физиологический солевой раствор, радиопротектор и неконъюгированный хелатор.41. The kit of claim 20, wherein said composition buffer comprises physiological saline, a radioprotector, and an unconjugated chelator. 42. Набор по п.41, в котором радиопротектор выбран из группы, состоящей из человеческого сывороточного альбумина (HSA), аскорбата, аскорбиновой кислоты, фенола, сульфитов, глутатиона, цистеина, гентизиновой кислоты, никотиновой кислоты, аскорбилпальмитата, НОР(:О)Н2, глицерина, сульфоксилата формальдегида натрия, Na2S2O5, Na2S2О3 и SO2.42. The kit according to paragraph 41, wherein the radioprotector is selected from the group consisting of human serum albumin (HSA), ascorbate, ascorbic acid, phenol, sulfites, glutathione, cysteine, gentisic acid, nicotinic acid, ascorbyl palmitate, HOP (: O) H 2 , glycerol, sodium formaldehyde sulfoxylate, Na 2 S 2 O 5 , Na 2 S 2 O 3 and SO 2 . 43. Набор по п.42, в котором радиопротектор является аскорбатом.43. The kit of claim 42, wherein the radioprotector is an ascorbate. 44. Набор по п.43, в котором концентрация аскорбата составляет приблизительно 1-100 мг/мл.44. The kit according to item 43, in which the concentration of ascorbate is approximately 1-100 mg / ml 45. Набор по п.42, в котором неконъюгированным хелатором является DTPA.45. The kit of claim 42, wherein the unconjugated chelator is DTPA. 46. Набор по п.45, в котором концентрация DTPA равна приблизительно 1 мМ.46. The kit according to item 45, in which the concentration of DTPA is approximately 1 mm. 47. Набор по п.20, который дополнительно содержит реакционный флакон.47. The kit according to claim 20, which further comprises a reaction vial. 48. Набор по п.20, который дополнительно содержит флакон радиоизотопа.48. The kit according to claim 20, which further comprises a bottle of a radioisotope.
RU2001126396/04A 1999-03-01 2000-02-29 Method for radioactive labeling proteins with therapeutic radioactive isotope and set for method realization RU2221807C2 (en)

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