1460944268-288982cf-7c95-41d4-a52d-632f4643f02c

1. A process for preparing a purified cell-binding agent cytotoxic agent conjugate comprising subjecting a mixture comprising a cell-binding agent cytotoxic agent conjugate and one or more impurities to a polyvinyl difluoride (PVDF) membrane to remove at least a portion of the impurities from the mixture, thereby providing a purified cell-binding agent cytotoxic agent conjugate.
2. The process of claim 1, wherein the process is sequentially repeated two, three, or four times.
3. The process of claim 1, wherein the process further comprises subjecting the mixture to an ion exchange chromatography membrane to remove at least a portion of the impurities from the mixture.
4. The process of claim 3, wherein the mixture is subjected to a PVDF membrane prior to subjecting the mixture to an ion exchange chromatography membrane.
5. The process of claim 3, wherein the mixture is subjected to an ion exchange chromatography membrane prior to subjecting the mixture to a PVDF membrane.
6. The process of claim 1, wherein the process comprises:
(a) contacting a cell-binding agent with a cytotoxic agent to form a first mixture comprising the cell-binding agent and the cytotoxic agent, then contacting the first mixture with a bifunctional crosslinking reagent comprising a linker, in a solution having a pH of about 4 to about 9, to provide a second mixture comprising the cell-binding agent cytotoxic agent conjugate comprising the cell-binding agent chemically coupled through the linker to the cytotoxic agent and one or more impurities;
(b) subjecting the second mixture to a polyvinyl difluoride (PVDF) membrane to remove at least a portion of the impurities, thereby providing a purified second mixture of the cell-binding agent cytotoxic agent conjugate; and
(c) subjecting the purified second mixture after step (b) to tangential flow filtration, selective precipitation, non-adsorptive chromatography, adsorptive filtration, adsorptive chromatography, or a combination thereof, to further purify the cell-binding agent-cytotoxic agent conjugate from the impurities and thereby prepare a purified third mixture of the cell-binding agent-cytotoxic agent conjugate, wherein the purified third mixture comprises a reduced amount of the impurities as compared to the purified second mixture.
7. The process of claim 6, wherein step (b) is sequentially repeated two, three, or four times prior to step (c).
8. The process of claim 6, wherein adsorptive chromatography is utilized in step (c).
9. The process of claim 6, wherein the adsorptive chromatography is selected from the group consisting of hydroxyapatite chromatography, hydrophobic charge induction chromatography (HCIC), hydrophobic interaction chromatography (HIC), ion exchange chromatography, mixed mode ion exchange chromatography, immobilized metal affinity chromatography (IMAC), dye ligand chromatography, affinity chromatography, reversed phase chromatography, and combinations thereof.
10. The process of claim 9, wherein the adsorptive chromatography is ion exchange chromatography.
11. The process of claim 10, wherein the ion exchange chromatography is ceramic hydroxyapatite (CHT) chromatography.
12. The process of claim 6, wherein tangential flow filtration is utilized in step (c).
13. The process of claim 6, wherein the contacting in step (a) is effected by providing the cell-binding agent in a reaction vessel, adding the cytotoxic agent to the reaction vessel to form the first mixture comprising the cell-binding agent and the cytotoxic agent, and then adding the bifunctional crosslinking reagent to the first mixture.
14. The process of claim 6, further comprising holding the mixture between steps a-b or steps b-c to release the unstably bound linkers from the cell-binding agent.
15. The process of claim 14, wherein the mixture is held for about 20 hours at a temperature of about 2\xb0 C. to about 8\xb0 C.
16. The process of claim 6, further comprising quenching the second mixture between steps (a)-(b) to quench any unreacted cytotoxic agent andor unreacted bifunctional crosslinking reagent.
17. The process of claim 16, wherein the mixture is quenched by contacting the second mixture with a quenching reagent that reacts with the free cytotoxic agent.
18. The process of claim 17, wherein the quenching reagent is selected from the group consisting of 4-maleimidobutyric acid, 3-maleimidopropionic acid, N-ethylmaleimide, iodoacetamide, and iodoacetamidopropionic acid.
19. The process of claim 6, wherein the process further comprises subjecting the mixture to an ion exchange chromatography membrane between steps (a) and (b).
20. The process of claim 6, wherein the process further comprises subjecting the mixture to an ion exchange chromatography membrane between steps (b) and (c).
21. The process of claim 1, wherein the process comprises:
(a) contacting a cell-binding agent with a bifunctional crosslinking reagent to covalently attach a linker to the cell-binding agent and thereby prepare a first mixture comprising cell-binding agents having linkers bound thereto,
(b) subjecting the first mixture to tangential flow filtration, selective precipitation, non-adsorptive chromatography, adsorptive filtration, adsorptive chromatography, or a combination thereof and thereby prepare a purified first mixture of cell-binding agents having linkers bound thereto,
(c) conjugating a cytotoxic agent to the cell-binding agents having linkers bound thereto in the purified first mixture by reacting the cell-binding agents having linkers bound thereto with a cytotoxic agent in a solution having a pH of about 4 to about 9 to prepare a second mixture comprising the cell-binding agent-cytotoxic agent conjugate comprising the cell-binding agent chemically coupled to the cytotoxic agent through the linker and one or more impurities,
(d) subjecting the second mixture to a polyvinyl difluoride (PVDF) membrane to remove at least a portion of the impurities, thereby providing a purified second mixture of the cell-binding agent cytotoxic agent conjugate; and
(e) subjecting the purified second mixture after step (d) to tangential flow filtration, selective precipitation, non-adsorptive chromatography, adsorptive filtration, adsorptive chromatography, or a combination thereof, to further purify the cell-binding agent-cytotoxic agent conjugate from the impurities and thereby prepare a purified third mixture of the cell-binding agent-cytotoxic agent conjugate, wherein the purified third mixture comprises a reduced amount of the impurities as compared to the purified second mixture.
22. The process of claim 21, wherein step (d) is sequentially repeated two, three, or four times prior to step (e).
23. The process of claim 21, wherein the process further comprises subjecting the mixture to an ion exchange chromatography membrane between steps (c) and (d).
24. The process of claim 21, wherein the process further comprises subjecting the mixture to an ion exchange chromatography membrane between steps (d) and (e).
25. The process of claim 21, wherein adsorptive chromatography is utilized in steps (b) and (d).
26. The process of claim 21, wherein tangential flow filtration is utilized in step (b) and adsorptive chromatography is utilized in step (d).
27. The process of claim 21, wherein adsorptive chromatography is utilized in step (b) and tangential flow filtration is utilized in step (d).
28. The process of claim 21, wherein the adsorptive chromatography is selected from the group consisting of hydroxyapatite chromatography, hydrophobic charge induction chromatography (HCIC), hydrophobic interaction chromatography (HIC), ion exchange chromatography, mixed mode ion exchange chromatography, immobilized metal affinity chromatography (IMAC), dye ligand chromatography, affinity chromatography, reversed phase chromatography, and combinations thereof.
29. The process of claim 28, wherein the adsorptive chromatography is ion-exchange chromatography.
30. The process of claim 29, wherein the ion-exchange chromatography is ceramic hydroxyapatite (CHT) chromatography.
31. The process of claim 21, wherein tangential flow filtration is utilized in steps (b) and (d).
32. The process of claim 21, wherein non-adsorptive chromatography is utilized in steps (b) and (d).
33. The process of claim 21, wherein the solution in step (c) comprises sucrose.
34. The process of claim 21, wherein the solution in step (c) comprises a buffering agent selected from the group consisting of a citrate buffer, an acetate buffer, a succinate buffer, and a phosphate buffer.
35. The process of claim 21, wherein the solution in step (c) comprises a buffering agent selected from the group consisting of HEPPSO (N-(2-Hydroxyethyl)piperazine-N\u2032-(2-hydroxypropanesulfonic acid)), POPSO (Piperazine-1,4-bis-(2-hydroxy-propane-sulfonic acid) dehydrate), HEPES (4-(2-hydroxyethyl)piperazine-1-ethanesulfonic acid), HEPPS (EPPS) (4-(2-hydroxyethyl)piperazine-1-propanesulfonic acid), TES (N-tris(hydroxymethyl)methyl-2-aminoethanesulfonic acid), and a combination thereof.
36. The process of claim 21, further comprising
(f) holding the mixture between at least one of steps a-b, steps b-c, steps c-d, and steps d-e to release the unstably bound linkers from the cell-binding agent.
37. The process of claim 1, wherein the process comprises:
(a) contacting a cell-binding agent with a bifunctional crosslinking reagent to covalently attach a linker to the cell-binding agent and thereby prepare a first mixture comprising cell-binding agents having linkers bound thereto,
(b) conjugating a cytotoxic agent to the cell-binding agents having linkers bound thereto in the first mixture by reacting the cell-binding agents having linkers bound thereto with a cytotoxic agent to prepare a second mixture comprising the cell-binding agent-cytotoxic agent conjugate comprising the cell-binding agent chemically coupled through the linker to the cytotoxic agent and one or more impurities,
(c) subjecting the second mixture to a polyvinyl difluoride (PVDF) membrane to remove at least a portion of the impurities, thereby providing a purified second mixture of the cell-binding agent cytotoxic agent conjugate; and
(d) subjecting the purified second mixture after step (c) to tangential flow filtration, selective precipitation, non-adsorptive chromatography, adsorptive filtration, adsorptive chromatography, or a combination thereof, to further purify the cell-binding agent-cytotoxic agent conjugate from the impurities and thereby prepare a purified third mixture of the cell-binding agent-cytotoxic agent conjugate, wherein the purified third mixture comprises a reduced amount of the impurities as compared to the purified second mixture.
38. The process of claim 37, wherein the first mixture is not subjected to purification between steps (a) and (b).
39. The process of claim 37, wherein step (c) is sequentially repeated two, three, or four times prior to step (d).
40. The process of claim 37, wherein the process further comprises subjecting the mixture to an ion exchange chromatography membrane between steps (b) and (c).
41. The process of claim 37, wherein the process further comprises subjecting the mixture to an ion exchange chromatography membrane between steps (c) and (d).
42. The process of claim 37, wherein adsorptive chromatography is utilized in step (d).
43. The process of claim 42, wherein the adsorptive chromatography is selected from the group consisting of hydroxyapatite chromatography, hydrophobic charge induction chromatography (HCIC), hydrophobic interaction chromatography (HIC), ion exchange chromatography, mixed mode ion exchange chromatography, immobilized metal affinity chromatography (IMAC), dye ligand chromatography, affinity chromatography, reversed phase chromatography, and combinations thereof.
44. The process of claim 43, wherein the adsorptive chromatography is ion-exchange chromatography.
45. The process of claim 44, wherein the ion-exchange chromatography is ceramic hydroxyapatite (CHT) chromatography.
46. The process of claim 37, wherein tangential flow filtration is utilized in step (d).
47. The process of claim 37, wherein non-adsorptive chromatography is utilized in step (d).
48. The process of claim 37, wherein the solution in step (b) comprises sucrose.
49. The process of claim 37, wherein the solution in step (b) comprises a buffering agent selected from the group consisting of a citrate buffer, an acetate buffer, a succinate buffer, and a phosphate buffer.
50. The process of claim 37, wherein the solution in step (b) comprises a buffering agent selected from the group consisting of HEPPSO (N-(2-Hydroxyethyl)piperazine-N\u2032-(2-hydroxypropanesulfonic acid)), POPSO (Piperazine-1,4-bis-(2-hydroxy-propane-sulfonic acid) dehydrate), HEPES (4-(2-hydroxyethyl)piperazine-1-ethanesulfonic acid), HEPPS (EPPS) (4-(2-hydroxyethyl)piperazine-1-propanesulfonic acid), TES (N-tris(hydroxymethyl)methyl-2-aminoethanesulfonic acid), and a combination thereof.
51. The process of claim 37, further comprising
(e) holding the mixture between at least one of steps a-b, steps b-c, and steps c-d to release the unstably bound linkers from the cell-binding agent.
52. The process of claim 1, wherein the one or more impurities are selected from the group of cytotoxic agent dimers, aggregates of the cell-binding agent cytotoxic agent conjugate, free cytotoxic agent, unconjugated linker, and mixtures thereof.
53. The process of claim 51, wherein the mixture comprises cytotoxic agent dimers as an impurity, and some portion of the cytotoxic agent dimers is removed from the mixture to provide the purified cell-binding agent cytotoxic agent conjugate.
54. The process of claim 53, wherein the cytotoxic agent dimer comprises DM1-DM1.
55. The process of claim 53, wherein the cytotoxic agent dimer comprises DM1-MCC-DM1.
56. The process of claim 53, wherein the cytotoxic agent dimer comprises DM1-DM1 and DM1-MCC-DM1.
57. The process of claim 52, wherein the mixture comprises aggregates of the cell-binding agent cytotoxic agent conjugate as an impurity, and some portion of the aggregates of the cell-binding agent cytotoxic agent conjugate is removed from the mixture to provide the purified cell-binding agent cytotoxic agent conjugate.
58. The process of claim 52, wherein the mixture comprises free cytotoxic agent as an impurity, and some portion of the free cytotoxic agent is removed from the mixture to provide the purified cell-binding agent cytotoxic agent conjugate.
59. The process of claim 52, wherein the mixture comprises unconjugated linker as an impurity, and some portion of the unconjugated linker is removed from the mixture to provide the purified cell-binding agent cytotoxic agent conjugate.
60. The process of claim 1, wherein the pH of the mixture that is subjected to PVDF membrane is about 4 to about 9.
61. The process of claim 60, wherein the pH of the mixture is about 7 to about 8.
62. The process of claim 60, wherein the pH of the mixture is about 8 to about 9.
63. The process of claim 62, wherein the pH of the mixture is about 8.5.
64. The process of claim 60, wherein the pH of the mixture is about 4.5 to about 5.5.
65. The process of claim 64, wherein the pH of the mixture is about 4.8.
66. The process of claim 1, wherein at least 50% of the one or more impurities are removed from the mixture.
67. The process of claim 1, wherein at least 75% of the one or more impurities are removed from the mixture.
68. The process of claim 1, wherein at least 90% of the one or more impurities are removed from the mixture.
69. The process of claim 1, wherein the PVDF membrane is selected from the group consisting of a 0.22 micron pore size membrane, a 0.45 micron pore size membrane, and a dual layer 0.450.22 micron pore size membrane.
70. The process of claim 1, wherein the PVDF membrane is gamma irradiated.
71. The process of claim 6, wherein the contacting in step (a) occurs in a solution having a pH of about 7 to about 9.
72. The process of claim 6, wherein the solution in step (a) comprises a buffering agent selected from the group consisting of a citrate buffer, an acetate buffer, a succinate buffer, and a phosphate buffer.
73. The process of claim 71, wherein the solution in step (a) comprises a buffering agent selected from the group consisting of HEPPSO (N-(2-Hydroxyethyl)piperazine-N\u2032-(2-hydroxypropanesulfonic acid)), POPSO (Piperazine-1,4-bis-(2-hydroxy-propane-sulfonic acid) dehydrate), HEPES (4-(2-hydroxyethyl)piperazine-1-ethanesulfonic acid), HEPPS (EPPS) (4-(2-hydroxyethyl)piperazine-1-propanesulfonic acid), TES (N-tris(hydroxymethyl)methyl-2-aminoethanesulfonic acid), and a combination thereof.
74. The process of claim 6, wherein the contacting in step (a) occurs at a temperature of about 16\xb0 C. to about 24\xb0 C.
75. The process of claim 6, wherein the contacting in step (a) occurs at a temperature of about 0\xb0 C. to about 15\xb0 C.
76. The process of claim 6, wherein the bifunctional crosslinking reagent is an acid labile linker, a disulfide containing linker, a photolabile linker, a peptidase labile linker, or an esterase labile linker.
77. The process of claim 6, wherein the bifunctional crosslinking reagent is a disulfide-containing cleavable linker.
78. The process of claim 6, wherein the bifunctional crosslinking reagent is a non-cleavable linker.
79. The process of claim 6, wherein the bifunctional crosslinking reagent comprises an N-succinimidyl ester moiety, an N-sulfosuccinimidyl ester moiety, a maleimido-based moiety, or a haloacetyl-based moiety.
80. The process of claim 77, wherein the bifunctional crosslinking reagent is selected from the group consisting of N-succinimidyl 3-(2-pyridyldithio)propionate (SPDP), N-succinimidyl 4-(2-pyridyldithio)butanoate (SPDB), N-succinimidyl 4-(2-pyridyldithio)pentanoate (SPP), and N-succinimidyl-4-(2-pyridyldithio)2-sulfo butanoate (sulfo-SPDB).
81. The process of claim 78, wherein the bifunctional crosslinking reagent is selected from the group consisting of N-succinimidyl 4-(maleimidomethyl)cyclohexanecarboxylate (SMCC), N-succinimidyl-4-(N-maleimidomethyl)-cyclohexane-1-carboxy-(6-amidocaproate) (LC-SMCC), \u03ba-maleimidoundecanoic acid N-succinimidyl ester (KMUA), \u03b3-maleimidobutyric acid N-succinimidyl ester (GMBS), \u03b2-maleimidopropyloxy-succinimidyl ester (BMPS), \u03b5-maleimidocaproic acid N-hydroxysuccinimide ester (EMCS), m-maleimidobenzoyl-N-hydroxysuccinimide ester (MBS), N-(\u03b1-maleimidoacetoxy)-succinimide ester (AMAS), succinimidyl-6-(\u03b2-maleimidopropionamido)hexanoate (SMPH), N-succinimidyl 4-(p-maleimidophenyl)-butyrate (SMPB), and N-(p-maleimidophenyl)isocyanate (PMPI), sulfo-Mal, PEG4-Mal and CX1-1.
82. The process of claim 1, wherein the cell-binding agent is selected from the group consisting of antibodies, interferons, interleukin 2 (IL-2), interleukin 3 (IL-3), interleukin 4 (IL-4), interleukin 6 (IL-6), insulin, EGF, TGF-\u03b1, FGF, G-CSF, VEGF, MCSF, GM-CSF, and transferrin.
83. The process of claim 82, wherein the cell-binding agent is an antibody.
84. The process of claim 83, wherein the antibody is a monoclonal antibody.
85. The process of claim 84, wherein the antibody is a humanized monoclonal antibody.
86. The process of claim 82, wherein the cell-binding agent is an antibody selected from the group consisting of huB4, huC242, trastuzumab, bivatuzumab, sibrotuzumab, huDS6, rituximab, anti-CD33 antibody, anti-CD27L antibody, anti-Her2 antibody, anti-EGFR antibody, anti-EGFRvIII antibody, Cripto, anti-CD138 antibody, anti-CD38 antibody, anti-EphA2 antibody, integrin targeting antibody, anti-CD37 antibody, anti-folate receptor antibody, anti-Her3 antibody, B-B4 antibody and anti-IGFIR antibody.
87. The process of claim 1, wherein the cytotoxic agent is selected from the group consisting of maytansinoids, taxanes, and CC1065.
88. The process of claim 87, wherein the cytotoxic agent is a maytansinoid.
89. The process of claim 88, wherein the maytansinoid comprises a thiol group.
90. The process of claim 89, wherein the maytansinoid is N2\u2032-deacetyl-N2\u2032-(3-mercapto-1-oxopropyl)-maytansine (DM1) or N2\u2032-de acetyl-N2\u2032-(4-methyl-4-mercapto-1-oxopentyl)-maytansine (DM4).
91. The process of claim 1, wherein the cytotoxic agent is DM1, the bifunctional crosslinking agent is SMCC, and the cell-binding agent is huCD37-3 antibody.
92. The process of claim 1, wherein the cytotoxic agent is DM1, the bifunctional crosslinking agent is SMCC, and the cell-binding agent is EGFR-7R antibody.
93. The process of claim 1, wherein the cytotoxic agent is DM1, the bifunctional crosslinking agent is SMCC, and the cell-binding agent is an anti-EFGRvIII antibody.
94. The process of claim 1, wherein the cytotoxic agent is DM1, the bifunctional crosslinking agent is SMCC, and the cell-binding agent is an anti-CD27L antibody.
95. The process of claim 1, wherein the cytotoxic agent is DM1, the bifunctional crosslinking agent is SMCC, and the cell-binding agent is trastuzumab.
96. The process of claim 6, wherein the process comprises
(a) contacting a cell-binding agent with a cytotoxic agent to form a first mixture comprising the cell-binding agent and the cytotoxic agent, then contacting the first mixture with a bifunctional crosslinking reagent comprising a linker, in a solution having a pH of about 4 to about 9, to provide a second mixture comprising the cell-binding agent cytotoxic agent conjugate comprising the cell-binding agent chemically coupled through the linker to the cytotoxic agent and one or more impurities;
(b) subjecting the second mixture to a PVDF membrane to remove at least a portion of the impurities from the mixture, thereby providing a purified second mixture of the cell-binding agent cytotoxic agent conjugate;
(c) quenching the purified second mixture after step (b) to quench any unreacted cytotoxic agent andor unreacted bifunctional crosslinking reagent;
(d) subjecting the quenched mixture after step (c) to a PVDF membrane to remove at least a portion of the impurities from the mixture, thereby providing a purified third mixture of the cell-binding agent cytotoxic agent conjugate;
(e) holding the purified third mixture to release the unstably bound linkers from the cell-binding agent;
(f) optionally subjecting the purified third mixture after step (c) to a PVDF membrane to remove at least a portion of the impurities from the mixture, thereby providing a purified fourth mixture of the cell-binding agent cytotoxic agent conjugate; and
(g) subjecting the purified fourth mixture after step (f) to tangential flow filtration, selective precipitation, non-adsorptive chromatography, adsorptive filtration, adsorptive chromatography, or a combination thereof, to further purify the cell-binding agent-cytotoxic agent conjugate from the impurities and thereby prepare a purified third mixture of the cell-binding agent-cytotoxic agent conjugate, wherein the purified third mixture comprises a reduced amount of the impurities as compared to the purified second mixture.
97. The process of claim 96, wherein the second mixture of step (b) has a pH of about 8.5.
98. The process of claim 97, wherein the quenched mixture of step (d) has a pH of about 4.8.

The claims below are in addition to those above.
All refrences to claim(s) which appear below refer to the numbering after this setence.

1. A method for providing point-to-multipoint services in a radio communication system, the method comprising:
performing Internet protocol header compression to form header compressed data;
in a point-to-point service, transmitting the header compressed data to one or more user equipment (UE) of the radio communication system;
in a point-to-multipoint service, transmitting the header compressed data from a packet data convergence protocol (PDCP) entity to a plurality of UEs, wherein the header compressed data is transmitted over a common transport channel to each of the plurality of UEs of the radio communication system;
wherein the Internet protocol header compression is performed in a PDCP entity located within a serving radio network controller (SRNC) in the case of the point-to-point service and within a controlling radio network controller (CRNC) in the case of the point-to-multipoint service,
wherein in the case of the point-to-point service, the PDCP entity is located within a layer of a first network protocol stack that is located above a layer in which a radio link control (RLC) entity is located and above a layer in which a medium access control (MAC) entity is located;
wherein the point-to-multipoint service is a multimedia broadcastmulticast service (MBMS) and one PDCP entity exists in the CRNC for the plurality of UEs of the radio communication system which individually receive the point-to-multipoint service from the CRNC in the case of the point-to-multipoint service, and
wherein in the case of the point-to-multipoint service, the PDCP entity is located within a layer of a second network protocol stack, which does not include a physical layer, that is located above a layer in which a radio link control (RLC) entity is located, and above a layer in which a medium access control (MAC) entity is located.
2. The method of claim 1, wherein the point-to-point service is employed if a total number of users within a cell is below the threshold value.
3. The method of claim 1, wherein the point-to-multipoint service is employed if a total number of users within a cell is at or above the threshold value.
4. The method of claim 1, wherein the Internet protocol header compression is respectively performed for each type of MBMS service to be provided.
5. The method of claim 1, wherein the point-to-point service is transmitting data from a single sending point to a single receiving point.
6. The method of claim 5, wherein the point-to-point service is based upon a total number of users within a cell of the radio communication system.
7. The method of claim 6, wherein the transmitting by point-to-point manner is via a dedicated channel.
8. The method of claim 1, wherein the point-to-multipoint service is transmitting data from a single sending point to multiple receiving points.
9. The method of claim 8, wherein the point-to-multipoint service is based upon a total number of users within a cell of the radio communication system.
10. The method of claim 1, wherein the header compression is performed at a central location for each type of MBMS service.
11. The method of claim 1, wherein the MBMS service is a service that is provided to a specified plurality of users.
12. A method of receiving data of a point-to-multipoint service in a radio communication system, the method comprising:
in a point-to-point service, receiving header compressed data from a radio communication system;
in a point-to-multipoint service, receiving the header compressed data from a packet data convergence protocol (PDCP) entity over a common transport channel;
decompressing the received header compressed data to allow a user to access the point-to-multipoint service,
wherein the header compressed data is formed in a PDCP entity located within a serving radio network controller (SRNC) in the case of the point-to-point service and within a controlling radio network controller (CRNC) in the case of the point-to-multipoint service,
wherein in the case of the point-to-point service, the PDCP entity is located within a layer of a first network protocol stack that is located above a layer in which a radio link control (RLC) entity is located and above a layer in which a medium access control (MAC) entity is located;
wherein the point-to-multipoint service is a multimedia broadcastmulticast service (MBMS) and one PDCP entity exists in the CRNC for the users of the radio communication system which individually receive the point-to-multipoint service from the CRNC in the case of the point-to-multipoint service, and
wherein in the case of the point-to-multipoint service, the PDCP entity is located within a layer of a second network protocol stack, which does not include a physical layer, that is located above a layer in which a radio link control (RLC) entity is located, and above a layer in which a medium access control (MAC) entity is located.
13. The method of claim 12, wherein the point-to-point service is receiving data by a single receiving point from a single sending point.
14. The method of claim 13, wherein the point-to-point service is based upon a total number of users within a cell of the radio communication system.
15. The method of claim 13, wherein the receiving by point-to-point service is via a dedicated channel.
16. The method of claim 12, wherein the point-to-multipoint service is receiving data by multiple receiving points from a single sending point.
17. The method of claim 16, wherein the point-to-multipoint service is based upon a total number of users within a cell of the radio communication system.
18. The method of claim 12, wherein the MBMS service is a service that is received by a specified plurality of users.
19. A radio communication system for providing and receiving data of a point-to-multipoint service, the radio communication system comprising:
one or more terminals;
a radio network controller coupled to the one or more terminals, the radio network controller comprising:
a header compressing portion that performs Internet protocol header compression to form header compressed data; and
a transmitter portion configured to:
in a point-to-point service, transmit the header compressed data to one or more user equipment (UE) of the radio communication system;
in a point-to-multipoint service, transmit the header compressed data from a packet data convergence protocol (PDCP) entity to a plurality of UEs, wherein the header compressed data is transmitted over a common transport channel to each of the plurality of UEs of the radio communication system;

wherein the point-to-multipoint service is a multimedia broadcastmulticast service (MBMS) and one PDCP entity exists in the CRNC for the plurality of UEs of the radio communication system which individually receive the point-to-multipoint service from the CRNC in the case of the point-to-multipoint service, and
wherein in the case of the point-to-point service, the PDCP entity is located within a aver of a first network protocol stack that is located above a layer in which a radio link control (RLC) entity is located and above a layer in which a medium access control (MAC) entity is located, and
wherein in the case of the point-to-multipoint service, the PDCP entity is located within a layer of a second network protocol stack, which does not include a physical layer, that is located above a layer in which a radio link control (RLC) entity is located, and above a layer in which a medium access control (MAC) entity is located.
20. The radio network controller of claim 19, wherein the PDCP entity respectively performs header compression for each type of MBMS service to be provided.
21. The radio network controller of claim 19, wherein the SRNC transmits via a dedicated transport channel.
22. In a radio communication system for providing and receiving data of a point-to-multipoint service, a user equipment comprising:
a receiving portion configured to:
in a point-to-point service, receive header compressed data from a radio communication system;
in a point-to-multipoint service, receive the header compressed data from a packet data convergence protocol (PDCP) entity over a common transport channel;

a header decompressing portion operatively connected with the receiving portion, the header decompressing portion decompressing the received header compressed data to allow a user to access the point-to-multipoint service,
wherein the header compressed data is formed in a PDCP entity Located within a serving radio network controller (SRNC) in the case of the point-to-point service and within a controlling radio network controller (CRNC) in the case of the point-to-multipoint service,
wherein in the case of the point-to-point service, the PDCP entity is located within a layer of a first network protocol stack that is located above a layer in which a radio link control (RLC) entity is located and above a layer in which a medium access control (MAC) entity is located;
wherein the point-to-multipoint service is a multimedia broadcastmulticast service (MBMS) and one PDCP entity exists in the CRNC for the users of the radio communication system which individually receive the point-to-multipoint service from the CRNC in the case of the point-to-multipoint service, and
wherein in the case of the point-to-multipoint service, the PDCP entity is located within a layer of a second network protocol stack, which does not include a physical layer, that is located above a layer in which a radio link control (RLC) entity is located, and above a layer in which a medium access control (MAC) entity is located.
23. The user equipment of claim 22, wherein the receiving portion receives via a dedicated transport channel.
24. A method for providing point-to-multipoint services in a radio communication system, the method comprising:
performing Internet protocol header compression to form header compressed data; and
in a point-to-point service, transmitting the header compressed data to one or more user equipment (UE) of the radio communication system;
in a point-to-multipoint service, transmitting the header compressed data from a packet data convergence protocol (PDCP) entity to a plurality of UEs, wherein the header compressed data is transmitted over a common transport channel to each of the plurality of UEs of the radio communication system;
wherein the Internet protocol header compression is performed in a PDCP entity located within a serving radio network controller (SRNC) in the case of the point-to-point service and within a controlling radio network controller (CRNC) in the case of the point-to-multipoint service,
wherein in the case of the point-to-point service, the PDCP entity is located within a layer of a first network protocol stack that is located above a layer in which a radio link control (RLC) entity is located and above a layer in which a medium access control (MAC) entity is located;
wherein the point-to-multipoint service is a multimedia broadcastmulticast service (MBMS) and one PDCP entity exists in the CRNC for the plurality of UEs of the radio communication system which individually receive the point-to-multipoint service from the CRNC in the case of the point-to-multipoint service, and
wherein in the case of the point-to-multipoint service, the PDCP entity is located within a layer of a second network protocol stack, which does not include a physical layer, that is located above a layer in which a radio link control (RLC) entity is located, and above a layer in which a medium access control (MAC) entity is located.
25. A method of providing Internet protocol header information in a wireless communication system, the method comprising:
performing header compression of Internet protocol header information to form compressed header data; and
in a point-to-point service, transmitting the header compressed data to one or more terminals of the wireless communication system;
in a point-to-multipoint service, transmitting the header compressed data from a packet data convergence protocol (PDCP) entity to a plurality of terminals, wherein the header compressed data is transmitted over a common transport channel to each of the plurality of terminals of the wireless communication system;
wherein the Internet protocol header compression is performed in a PDCP entity located within a serving radio network controller (SRNC) in the case of the point-to-point service and within a controlling radio network controller (CRNC) in the case of the point-to-multipoint service,
wherein in the case of the point-to-point service, the PDCP entity is located within a layer of a first network protocol stack that is located above a layer in which a radio link control (RLC) entity is located and above a layer in which a medium access control (MAC) entity is located;
wherein the point-to-multipoint service is a multimedia broadcastmulticast service (MBMS) and one PDCP entity exists in the CRNC for the plurality of terminals of the wireless communication system which individually receive the point-to-multipoint service from the CRNC in case of the point-to-multipoint service, and
wherein in the case of the point-to-multipoint service, the PDCP entity is located within a layer of a second network protocol stack, which does not include a physical layer, that is located above a layer in which a radio link control (RLC) entity is located, and above a layer in which a medium access control (MAC) entity is located.
26. The method of claim 25, wherein the header compression is performed once for the data transmitted to the plurality of terminals when the data is transmitted in the point-to-multipoint manner.
27. The method of claim 25, wherein the compressed header data is provided to the plurality of terminals when the data is transmitted in the point-to-multipoint manner.
28. The method of claim 25, wherein the threshold value is associated with a number of terminals.
29. The method of claim 25, wherein at least part of the Internet protocol header information is not compressed.
30. A wireless communication system for providing Internet protocol header information, the wireless communication system comprising:
one or more terminals;
a radio network controller coupled to the one or more terminals, the radio network controller comprising:
a header compression module adapted to receive Internet protocol header information from an internet protocol module and compress the Internet protocol header information to form compressed header data;
a transmitter module configured to:
in a point-to-point service, transmit the header compressed data to one or more terminals of the wireless communication system; and
in a point-to-multipoint service, transmit the header compressed data from a packet data convergence protocol (PDCP) entity to a plurality of terminals, wherein the header is transmitted over a common transport channel to each of the plurality of terminals of the wireless communication system;

a receiving module configured to:
in a point-to-point service, receive header compressed data from the wireless communication system;
in a point-to-multipoint service, receive the header compressed data over a common transport channel from the wireless communication system;

wherein in the case of the point-to-point service, the PDCP entity is located within a layer of a first network protocol stack that is located above a layer in which a radio link control (RLC) entity is located and above a layer in which a medium access control (MAC) entity is located;
wherein a multimedia broadcastmulticast service (MBMS) is provided to the plurality of terminals and one PDCP entity exists in the CRNC for the plurality of terminals of the wireless communication system which individually receive the point-to-multipoint service from the CRNC in the case of the point-to-multipoint service, and
wherein in the case of the point-to-multipoint service, the PDCP entity is located within a layer of a second network protocol stack, which does not include a physical layer, that is located above a layer in which a radio link control (RLC) entity is located, and above a layer in which a medium access control (MAC) entity is located.
31. The wireless communication system of claim 30, wherein the compressed header data is provided to the plurality of terminals when the data is transmitted in a point-to-multipoint manner.
32. The wireless communication system of claim 30, wherein the compressed header data is transmitted in the point-to-point manner if the number of terminals is below the threshold value.
33. The wireless communication system of claim 30, wherein the compressed header data is transmitted in the point-to-multipoint manner if the number of terminals is at or above the threshold value.