AR122622A2 - FORMULATION FOR ANTI-a4b7 ANTIBODY - Google Patents

FORMULATION FOR ANTI-a4b7 ANTIBODY

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Publication number
AR122622A2
AR122622A2 ARP210101621A ARP210101621A AR122622A2 AR 122622 A2 AR122622 A2 AR 122622A2 AR P210101621 A ARP210101621 A AR P210101621A AR P210101621 A ARP210101621 A AR P210101621A AR 122622 A2 AR122622 A2 AR 122622A2
Authority
AR
Argentina
Prior art keywords
antibody
seq
set forth
reducing sugar
formulations
Prior art date
Application number
ARP210101621A
Other languages
Spanish (es)
Inventor
Willow Diluzio
Nobel T Truong
Original Assignee
Millennium Pharm Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Millennium Pharm Inc filed Critical Millennium Pharm Inc
Publication of AR122622A2 publication Critical patent/AR122622A2/en

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  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

Abstract

Se describen formulaciones de anticuerpo que comprenden una mezcla de un azúcar no reductor, un anticuerpo anti-a4b7 y al menos un aminoácido. Las formulaciones descritas tienen una estabilidad mejorada, una formación de agregados reducida y pueden retrasar la degradación del anticuerpo anti-a4b7 en las mismas o presentar cualquier combinación de las mismas. La presente invención proporciona además un régimen de dosificación seguro de estas formulaciones de anticuerpo que es fácil de seguir y que da como resultado una cantidad terapéuticamente eficaz del anticuerpo anti-a4b7 in vivo. Reivindicación 1: Una formulación estable caracterizada porque comprende una mezcla de un azúcar no reductor, un anticuerpo humanizado anti-a4b7 y al menos un aminoácido libre, en la que la formulación está en forma sólida, en la que la relación molar del azúcar no reductor con el anticuerpo anti-a4b7 (mol:mol) es superior a 600: 1, y en el que el anticuerpo anti-47 comprende una región variable de cadena pesada que comprende una región determinante de la complementariedad 1 (CDR1) como se establece en la SEQ ID Nº 8, una CDR2 como se establece en la SEQ ID Nº 9, y una CDR3 como se establece en la SEQ ID Nº 10, y comprende una región variable de cadena ligera que comprende una CDR1 como se establece en la SEQ ID Nº 11, una CDR2 como se establece en la SEQ ID Nº 12, y una CDR3 como se establece en la SEQ ID Nº 13.Antibody formulations comprising a mixture of a non-reducing sugar, an anti-a4b7 antibody and at least one amino acid are disclosed. The disclosed formulations have improved stability, reduced aggregate formation, and may delay anti-a4b7 antibody degradation therein or exhibit any combination thereof. The present invention further provides a safe dosage regimen for these antibody formulations that is easy to follow and that results in a therapeutically effective amount of anti-a4b7 antibody in vivo. Claim 1: A stable formulation characterized in that it comprises a mixture of a non-reducing sugar, a humanized anti-a4b7 antibody and at least one free amino acid, in which the formulation is in solid form, in which the molar ratio of the non-reducing sugar with the anti-a4b7 antibody (mol:mol) is greater than 600:1, and wherein the anti-47 antibody comprises a heavy chain variable region comprising a complementarity determining region 1 (CDR1) as set forth in SEQ ID No. 8, a CDR2 as set forth in SEQ ID No. 9, and a CDR3 as set forth in SEQ ID No. 10, and comprises a light chain variable region comprising a CDR1 as set forth in SEQ ID No. No. 11, a CDR2 as set forth in SEQ ID No. 12, and a CDR3 as set forth in SEQ ID No. 13.

ARP210101621A 2011-05-02 2021-06-14 FORMULATION FOR ANTI-a4b7 ANTIBODY AR122622A2 (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US201161481533P 2011-05-02 2011-05-02

Publications (1)

Publication Number Publication Date
AR122622A2 true AR122622A2 (en) 2022-09-21

Family

ID=83444613

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP210101621A AR122622A2 (en) 2011-05-02 2021-06-14 FORMULATION FOR ANTI-a4b7 ANTIBODY

Country Status (1)

Country Link
AR (1) AR122622A2 (en)

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