JPWO2021062372A5 - - Google Patents
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- JPWO2021062372A5 JPWO2021062372A5 JP2022518964A JP2022518964A JPWO2021062372A5 JP WO2021062372 A5 JPWO2021062372 A5 JP WO2021062372A5 JP 2022518964 A JP2022518964 A JP 2022518964A JP 2022518964 A JP2022518964 A JP 2022518964A JP WO2021062372 A5 JPWO2021062372 A5 JP WO2021062372A5
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- antibody composition
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Description
本明細書では、本開示の好ましい実施形態が説明されており、例えば本開示を実行するための本発明者らに既知の最良の形態が説明されている。それらの好ましい実施形態の変形形態は、上記の記載を読めば当業者には明らかであろう。本発明者らは、当業者が必要に応じてこのような変形形態を採用することを期待し、また、本発明者らは、本明細書で具体的に記載されている形態以外で本開示が実施されることを意図している。したがって、本開示は、適用される法により認められる通り、本明細書に添付される特許請求の範囲に列挙されている主題の全ての変更形態及び均等物を含む。さらに、上記の要素の任意の組み合わせは、別途本明細書で指示されない限り又は文脈と明らかに矛盾しない限り、その全ての可能な変形形態で本開示に包含される。
本発明は、例えば、以下の項目を提供する。
（項目１）
抗体組成物の製品品質を決定する方法であって、前記抗体組成物のＡＤＣＣ活性レベルが、前記抗体組成物の製品品質の基礎となる基準であり、前記方法が、
ｉ．抗体組成物のサンプルの総非フコシル化（ＴＡＦ）グリカン含量を決定する工程、並びに
ｉｉ．（ｉ）で決定された前記ＴＡＦグリカン含量が目標範囲内である場合に、前記抗体組成物の前記製品品質を、許容できる、及び／又はＡＤＣＣ活性レベル基準を達成していると決定する工程
を含み、
ＴＡＦグリカン含量の前記目標範囲は、（１）参照抗体のＡＤＣＣ活性レベルの目標範囲、及び（２）前記抗体組成物のＡＤＣＣ活性レベルを前記抗体組成物の前記ＴＡＦグリカン含量と相関させる第１のモデルに基づき、
前記第１のモデルによって予測されるＡＤＣＣが、第２のモデルによって予測されるＡＤＣＣの約９５％～約１０５％であり、ここで、前記第２のモデルが、前記抗体組成物のＡＤＣＣ活性レベルを、前記抗体組成物の高マンノース（ＨＭ）グリカン含量及び前記抗体組成物の非フコシル化（ＡＦ）グリカン含量と相関させる、方法。
（項目２）
前記第１のモデルによって予測されるＡＤＣＣが、前記第２のモデルによって予測されるＡＤＣＣの約１００％である、項目１に記載の方法。
（項目３）
前記第１のモデルのｐ値が０．０００１未満であり、及び／又は前記第２のモデルのｐ値が０．０００１未満である、項目１又は２に記載の方法。
（項目４）
前記第１のモデルによって予測されるＡＤＣＣ活性レベルが約１２Ｑ×ＴＡＦ％であり、ここで、Ｑは前記抗体が結合する抗原の抗体結合部位の数であり、ＴＡＦ％が前記抗体組成物のＴＡＦグリカン含量である、項目１～３のいずれか一項に記載の方法。
（項目５）
Ｑが２である、項目４に記載の方法。
（項目６）
前記第１のモデルによって予測されるＡＤＣＣ活性レベルが、約２４×ＴＡＦ％である、項目１～５のいずれか一項に記載の方法。
（項目７）
前記第２のモデルによって予測されるＡＤＣＣ活性レベルが、約２７×ＨＭ％＋約２２×ＡＦ％であり、ここで、ＡＦ％は前記抗体組成物のＡＦグリカン含量であり、ＨＭ％が前記抗体組成物のＨＭグリカン含量である、項目１～６のいずれか一項に記載の方法。
（項目８）
Ｑが１である、項目４に記載の方法。
（項目９）
前記第１のモデルによって予測されるＡＤＣＣ活性レベルが、約１２×ＴＡＦ％である、項目１～４及び８のいずれか一項に記載の方法。
（項目１０）
前記第２のモデルによって予測されるＡＤＣＣ活性レベルが、約１４．８×ＨＭ％＋約１２．８×ＡＦ％である、項目１～３、７及び８のいずれか一項に記載の方法。
（項目１１）
前記参照抗体がリツキシマブである、項目１～１０のいずれか一項に記載の方法。
（項目１２）
前記参照抗体がインフリキシマブである、項目１～１１のいずれか一項に記載の方法。
（項目１３）
前記方法が品質管理（ＱＣ）アッセイである、項目１～１２のいずれか一項に記載の方法。
（項目１４）
前記方法がインプロセスＱＣアッセイである、項目１～１３のいずれか一項に記載の方法。
（項目１５）
前記サンプルが、インプロセス材料のサンプルである、項目１～１４のいずれか一項に記載の方法。
（項目１６）
前記ＴＡＦグリカン含量が、回収前又は回収後に決定される、項目１～１５のいずれか一項に記載の方法。
（項目１７）
前記ＴＡＦグリカン含量が、クロマトグラフィ工程後に決定される、項目１～１６のいずれか一項に記載の方法。
（項目１８）
前記クロマトグラフィ工程が、キャプチャークロマトグラフィ、中間クロマトグラフィ、及び／又はポリッシュクロマトグラフィを含む、項目１７に記載の方法。
（項目１９）
前記ＴＡＦグリカン含量が、ウイルス不活化及び中和、ウイルス濾過、又は緩衝液交換の後に決定される、項目１７又は１８に記載の方法。
（項目２０）
前記方法がロットリリースアッセイである、項目１～１９のいずれか一項に記載の方法。
（項目２１）
前記サンプルが製造ロットから得られる、項目１～２０のいずれか一項に記載の方法。
（項目２２）
前記ＴＡＦグリカン含量が目標範囲内である場合、前記抗体組成物を下流プロセスのために選択する工程をさらに含む、項目１～２１のいずれか一項に記載の方法。
（項目２３）
（ｉ）で決定されたＴＡＦグリカン含量が前記目標範囲内でない場合、細胞培養の１つ以上の条件を改変して、改変細胞培養物を得る、項目１～２２のいずれか一項に記載の方法。
（項目２４）
前記細胞培養の１つ以上の条件を改変した後に得られる前記抗体組成物のサンプルのＴＡＦグリカン含量を決定する工程をさらに含む、項目２３に記載の方法。
（項目２５）
（ｉ）で決定されたＴＡＦグリカン含量が前記目標範囲内でない場合、前記方法が、（ｉｉｉ）前記細胞培養の１つ以上の条件を改変して改変細胞培養物を得る工程、及び（ｉｖ）前記改変細胞培養物から得られる前記抗体組成物のサンプルのＴＡＦグリカン含量を決定する工程をさらに含む、項目１～２４のいずれか一項に記載の方法。
（項目２６）
（ｉ）で決定されたＴＡＦグリカン含量が前記目標範囲内でない場合、前記方法が、（ｉｖ）で決定されたＴＡＦグリカン含量が前記目標範囲内になるまで、（ｉｉｉ）及び（ｉｖ）をさらに含む、項目２５に記載の方法。
（項目２７）
前記抗体組成物のＡＤＣＣ活性を直接測定するアッセイが、前記ＴＡＦグリカン含量が前記目標範囲外である場合にのみ、前記抗体組成物に対して実施される、項目１～２６のいずれか一項に記載の方法。
（項目２８）
前記抗体組成物のＡＤＣＣ活性を直接測定するアッセイが、前記ＴＡＦグリカン含量が前記目標範囲内である場合、前記抗体組成物に対して実施されない、項目１～２７のいずれか一項に記載の方法。
（項目２９）
抗体組成物のＡＤＣＣ活性を直接測定する前記アッセイが、抗原発現細胞及びエフェクター細胞の両方に結合する抗体に結合するエフェクター細胞によって、検出可能な薬剤を含む抗原発現細胞の溶解時の前記検出可能な薬剤の放出を測定する細胞ベースのアッセイである、項目２３又は２４に記載の方法。
（項目３０）
項目１～２９のいずれか一項に記載の方法に従って、第１の時点で得られた第１のサンプルと、前記第１の時点とは異なる第２の時点で採取された第２のサンプルとを用いて、抗体組成物の製品品質を決定する工程を含む、抗体組成物の製品品質をモニターする方法。
（項目３１）
前記第１のサンプル及び前記第２のサンプルのそれぞれが、インプロセス材料のサンプルである、項目３０に記載の方法。
（項目３２）
前記第１のサンプルがインプロセス材料のサンプルであり、前記第２のサンプルが製造ロットのサンプルである、項目３０に記載の方法。
（項目３３）
前記第１のサンプルが、前記細胞培養の１つ以上の条件を改変する前に得られるサンプルであり、前記第２のサンプルが、前記細胞培養の１つ以上の条件を改変した後に得られるサンプルである、項目３０に記載の方法。
（項目３４）
抗体組成物を製造する方法であって、前記抗体組成物の製品品質を決定する工程を含み、前記抗体組成物の製品品質は項目１～２９のいずれか一項に記載の方法に従って決定され、前記サンプルはインプロセス材料であり、（ｉ）で決定されたＴＡＦグリカン含量が前記目標範囲でない場合、前記方法は、（ｉｉｉ）前記細胞培養の１つ以上の条件を改変して改変細胞培養物を得る工程、及び（ｉｖ）前記改変細胞培養物から得られた前記抗体組成物のサンプルのＴＡＦグリカン含量を決定する工程、任意選択で、前記ＴＡＦグリカン含量が前記目標範囲内になるまで、工程（ｉｉｉ）及び（ｉｖ）を繰り返す工程をさらに含む方法。
（項目３５）
前記ＴＡＦグリカン含量の目標範囲を達成するため、前記細胞培養の１つ以上の条件を改変して、主にＨＭグリカン含量を改変する、項目３４に記載の方法。
（項目３６）
前記ＴＡＦグリカン含量の目標範囲を達成するため、前記細胞培養の１つ以上の条件を改変して、主にＡＦグリカン含量を改変する、項目３４に記載の方法。
Preferred embodiments of this disclosure are described herein, including the best mode known to the inventors for carrying out the disclosure. Variations on these preferred embodiments will be apparent to those skilled in the art upon reading the above description. The inventors expect those skilled in the art to adopt such variations as necessary, and the inventors do not intend to use the present disclosure in other forms than those specifically described herein. is intended to be implemented. Accordingly, this disclosure includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Furthermore, any combination of the above elements is encompassed by this disclosure in all possible variations thereof, unless otherwise indicated herein or clearly contradicted by context.
The present invention provides, for example, the following items.
(Item 1)
A method for determining product quality of an antibody composition, wherein the ADCC activity level of the antibody composition is a criterion underlying the product quality of the antibody composition, the method comprising:
i. determining the total afucosylated (TAF) glycan content of a sample of the antibody composition; and
ii. determining the product quality of the antibody composition as acceptable and/or achieving ADCC activity level criteria if the TAF glycan content determined in (i) is within a target range;
including;
The target range of TAF glycan content comprises: (1) a target range of ADCC activity levels of a reference antibody; and (2) a first method that correlates the ADCC activity level of the antibody composition with the TAF glycan content of the antibody composition. Based on the model
the ADCC predicted by the first model is about 95% to about 105% of the ADCC predicted by the second model, wherein the second model with high mannose (HM) glycan content of said antibody composition and non-fucosylated (AF) glycan content of said antibody composition.
(Item 2)
2. The method of item 1, wherein the ADCC predicted by the first model is about 100% of the ADCC predicted by the second model.
(Item 3)
The method according to item 1 or 2, wherein the first model has a p-value of less than 0.0001, and/or the second model has a p-value of less than 0.0001.
(Item 4)
The ADCC activity level predicted by the first model is approximately 12Q x TAF%, where Q is the number of antibody binding sites on the antigen to which the antibody binds and TAF% is the TAF of the antibody composition. The method according to any one of items 1 to 3, wherein the glycan content is glycan content.
(Item 5)
The method according to item 4, wherein Q is 2.
(Item 6)
6. The method of any one of items 1-5, wherein the ADCC activity level predicted by the first model is about 24 x TAF%.
(Item 7)
The ADCC activity level predicted by the second model is about 27 x HM% + about 22 x AF%, where AF% is the AF glycan content of the antibody composition and HM% is the antibody composition. 7. The method according to any one of items 1 to 6, wherein the HM glycan content of the composition.
(Item 8)
The method according to item 4, wherein Q is 1.
(Item 9)
9. The method of any one of items 1-4 and 8, wherein the ADCC activity level predicted by the first model is about 12 x TAF%.
(Item 10)
9. The method of any one of items 1-3, 7 and 8, wherein the ADCC activity level predicted by the second model is about 14.8 x HM% + about 12.8 x AF%.
(Item 11)
The method according to any one of items 1 to 10, wherein the reference antibody is rituximab.
(Item 12)
The method according to any one of items 1 to 11, wherein the reference antibody is infliximab.
(Item 13)
13. The method according to any one of items 1 to 12, wherein the method is a quality control (QC) assay.
(Item 14)
14. The method according to any one of items 1 to 13, wherein the method is an in-process QC assay.
(Item 15)
15. The method of any one of items 1-14, wherein the sample is a sample of an in-process material.
(Item 16)
16. The method of any one of items 1-15, wherein the TAF glycan content is determined before or after recovery.
(Item 17)
17. The method according to any one of items 1 to 16, wherein the TAF glycan content is determined after a chromatography step.
(Item 18)
18. The method according to item 17, wherein the chromatography step comprises capture chromatography, intermediate chromatography, and/or polish chromatography.
(Item 19)
19. The method of item 17 or 18, wherein the TAF glycan content is determined after virus inactivation and neutralization, virus filtration, or buffer exchange.
(Item 20)
20. The method according to any one of items 1 to 19, wherein said method is a lot release assay.
(Item 21)
21. The method of any one of items 1-20, wherein the sample is obtained from a manufacturing lot.
(Item 22)
22. The method of any one of items 1-21, further comprising selecting the antibody composition for downstream processing if the TAF glycan content is within the target range.
(Item 23)
If the TAF glycan content determined in (i) is not within the target range, one or more conditions of the cell culture are modified to obtain a modified cell culture. Method.
(Item 24)
24. The method of item 23, further comprising determining the TAF glycan content of a sample of the antibody composition obtained after altering one or more conditions of the cell culture.
(Item 25)
If the TAF glycan content determined in (i) is not within the target range, the method comprises (iii) modifying one or more conditions of the cell culture to obtain a modified cell culture; and (iv) 25. The method of any one of items 1-24, further comprising determining the TAF glycan content of a sample of the antibody composition obtained from the modified cell culture.
(Item 26)
If the TAF glycan content determined in (i) is not within the target range, the method further comprises (iii) and (iv) until the TAF glycan content determined in (iv) is within the target range. The method according to item 25, comprising:
(Item 27)
According to any one of items 1 to 26, an assay that directly measures the ADCC activity of the antibody composition is performed on the antibody composition only if the TAF glycan content is outside the target range. Method described.
(Item 28)
28. The method of any one of items 1-27, wherein an assay that directly measures the ADCC activity of the antibody composition is not performed on the antibody composition if the TAF glycan content is within the target range. .
(Item 29)
The assay directly measures the ADCC activity of an antibody composition, wherein said detectable agent upon lysis of an antigen-expressing cell containing a detectable agent is detected by an effector cell binding to an antibody that binds both an antigen-expressing cell and an effector cell. 25. The method of item 23 or 24, which is a cell-based assay for measuring drug release.
(Item 30)
A first sample obtained at a first time point and a second sample taken at a second time point different from the first time point according to the method described in any one of items 1 to 29. A method for monitoring the product quality of an antibody composition, comprising the step of determining the product quality of the antibody composition using a method.
(Item 31)
31. The method of item 30, wherein each of the first sample and the second sample is a sample of an in-process material.
(Item 32)
31. The method of item 30, wherein the first sample is an in-process material sample and the second sample is a manufacturing lot sample.
(Item 33)
the first sample is a sample obtained before altering one or more conditions of the cell culture, and the second sample is a sample obtained after altering the one or more conditions of the cell culture. The method according to item 30.
(Item 34)
A method for producing an antibody composition, the method comprising: determining the product quality of the antibody composition, the product quality of the antibody composition being determined according to the method according to any one of items 1 to 29; If the sample is an in-process material and the TAF glycan content determined in (i) is not in the target range, the method includes (iii) modifying one or more conditions of the cell culture to produce a modified cell culture. and (iv) determining the TAF glycan content of a sample of the antibody composition obtained from the modified cell culture, optionally until the TAF glycan content is within the target range. A method further comprising repeating (iii) and (iv).
(Item 35)
35. The method of item 34, wherein one or more conditions of the cell culture are modified to primarily modify HM glycan content to achieve the target range of TAF glycan content.
(Item 36)
35. The method of item 34, wherein one or more conditions of the cell culture are modified to primarily modify AF glycan content to achieve the target range of TAF glycan content.
Claims (22)
ｉ．前記抗体組成物の製品品質を決定する工程であって、前記抗体組成物のＡＤＣＣ活性レベルが、前記抗体組成物の製品品質の基礎となる基準であり、前記抗体組成物の製品品質が、前記抗体組成物のサンプルの総非フコシル化（ＴＡＦ）グリカン含量を決定することによって決定され、前記サンプルが、前記抗体組成物の抗体を発現する細胞を含む細胞培養物のインプロセス材料のサンプルである、工程； i. A step of determining the product quality of the antibody composition, wherein the ADCC activity level of the antibody composition is a standard on which the product quality of the antibody composition is based, and the product quality of the antibody composition is determined by the determined by determining the total afucosylated (TAF) glycan content of a sample of the antibody composition, said sample being a sample of in-process material of a cell culture comprising cells expressing antibodies of said antibody composition. , process;
ｉｉ．前記ＴＡＦグリカン含量が目標範囲内でない場合、細胞培養の１つ以上の条件を改変して、改変細胞培養物を得る工程； ii. if the TAF glycan content is not within the target range, modifying one or more conditions of cell culture to obtain a modified cell culture;
ｉｉｉ．前記改変細胞培養物から得られる前記抗体組成物のサンプルのＴＡＦグリカン含量を決定する工程；および iii. determining the TAF glycan content of a sample of the antibody composition obtained from the modified cell culture; and
ｉｖ．必要に応じて、前記ＴＡＦグリカン含量が前記目標範囲内になるまで、（ｉｉ）および（ｉｉｉ）を繰り返す工程 iv. Optionally, repeating (ii) and (iii) until the TAF glycan content is within the target range.
を含み、ＴＡＦグリカン含量の前記目標範囲は、（１）参照抗体のＡＤＣＣ活性レベルの目標範囲、及び（２）前記抗体組成物のＡＤＣＣ活性レベルを前記抗体組成物の前記ＴＡＦグリカン含量と相関させる第１のモデルに基づいており、(1) a target range of ADCC activity levels of a reference antibody, and (2) correlating the ADCC activity level of the antibody composition with the TAF glycan content of the antibody composition. Based on the first model,
前記第１のモデルによって予測されるＡＤＣＣが、第２のモデルによって予測されるＡＤＣＣの約９５％～約１０５％であり、ここで、前記第２のモデルが、前記抗体組成物のＡＤＣＣ活性レベルを、前記抗体組成物の高マンノース（ＨＭ）グリカン含量及び非フコシル化（ＡＦ）グリカン含量と相関させる、方法。 the ADCC predicted by the first model is about 95% to about 105% of the ADCC predicted by the second model, wherein the second model with high mannose (HM) glycan content and non-fucosylated (AF) glycan content of the antibody composition.
ｉ．第１の時点で得られた前記抗体組成物の第１のサンプルの総非フコシル化（ＴＡＦ）グリカン含量を決定する工程； i. determining the total afucosylated (TAF) glycan content of a first sample of said antibody composition obtained at a first time point;
ｉｉ．前記ＴＡＦグリカン含量が目標範囲内でない場合、細胞培養の１つ以上の条件を改変して改変細胞培養物を得る工程； ii. if the TAF glycan content is not within the target range, modifying one or more conditions of cell culture to obtain a modified cell culture;
ｉｉｉ．前記第１の時点とは異なる第２の時点で採取された第２のサンプルのＴＡＦグリカン含量を決定する工程であって、前記第２のサンプルが、前記改変細胞培養物から得られる前記抗体組成物のサンプルである、工程；および iii. determining the TAF glycan content of a second sample taken at a second time point different from the first time point, the second sample comprising the antibody composition obtained from the modified cell culture; a process that is a sample of a thing; and
ｉｖ．必要に応じて、前記ＴＡＦグリカン含量が前記目標範囲内になるまで、（ｉｉ）及び（ｉｉｉ）を繰り返す工程 iv. If necessary, repeating (ii) and (iii) until the TAF glycan content is within the target range.
を含み、ＴＡＦグリカン含量の前記目標範囲は、（１）参照抗体のＡＤＣＣ活性レベルの目標範囲、及び（２）前記抗体組成物のＡＤＣＣ活性レベルを前記抗体組成物の前記ＴＡＦグリカン含量と相関させる第１のモデルに基づいており、(1) a target range of ADCC activity levels of a reference antibody, and (2) correlating the ADCC activity level of the antibody composition with the TAF glycan content of the antibody composition. Based on the first model,
前記第１のモデルによって予測されるＡＤＣＣが、第２のモデルによって予測されるＡＤＣＣの約９５％～約１０５％であり、ここで、前記第２のモデルが、前記抗体組成物のＡＤＣＣ活性レベルを、前記抗体組成物の高マンノース（ＨＭ）グリカン含量及び非フコシル化（ＡＦ）グリカン含量と相関させる、方法。 the ADCC predicted by the first model is about 95% to about 105% of the ADCC predicted by the second model, wherein the second model with high mannose (HM) glycan content and non-fucosylated (AF) glycan content of the antibody composition.
ｉ．第１の時点で得られた前記抗体組成物の第１のサンプルの総非フコシル化（ＴＡＦ）グリカン含量を決定する工程； i. determining the total afucosylated (TAF) glycan content of a first sample of said antibody composition obtained at a first time point;
ｉｉ．前記第１の時点とは異なる第２の時点で得られた前記抗体組成物の第２のサンプルの総非フコシル化（ＴＡＦ）グリカン含量を決定する工程 ii. determining the total afucosylated (TAF) glycan content of a second sample of the antibody composition obtained at a second time point different from the first time point;
を含み、前記ＴＡＦグリカン含量が目標範囲内である場合に、前記抗体組成物の前記製品品質を、許容できる、及び／又はＡＤＣＣ活性レベル基準を達成していると決定され、the product quality of the antibody composition is determined to be acceptable and/or achieving ADCC activity level criteria when the TAF glycan content is within a target range;
ＴＡＦグリカン含量の前記目標範囲は、（１）参照抗体のＡＤＣＣ活性レベルの目標範囲、及び（２）前記抗体組成物のＡＤＣＣ活性レベルを前記抗体組成物の前記ＴＡＦグリカン含量と相関させる第１のモデルに基づいており、 The target range of TAF glycan content comprises: (1) a target range of ADCC activity levels of a reference antibody; and (2) a first method that correlates the ADCC activity level of the antibody composition with the TAF glycan content of the antibody composition. Based on the model
前記第１のモデルによって予測されるＡＤＣＣが、第２のモデルによって予測されるＡＤＣＣの約９５％～約１０５％であり、ここで、前記第２のモデルが、前記抗体組成物のＡＤＣＣ活性レベルを、前記抗体組成物の高マンノース（ＨＭ）グリカン含量及び非フコシル化（ＡＦ）グリカン含量と相関させる、方法。 the ADCC predicted by the first model is about 95% to about 105% of the ADCC predicted by the second model, wherein the second model with high mannose (HM) glycan content and non-fucosylated (AF) glycan content of the antibody composition.
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