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1. WO2021061504 - METHODS AND COMPOSITIONS COMPRISING AN ANTI-CTLA4 MONOCLONAL ANTIBODY WITH REDUCED HOST CELL PROTEINS AND INCREASED POLYSORBATE-80 STABILITY

Publication Number WO/2021/061504
Publication Date 01.04.2021
International Application No. PCT/US2020/051355
International Filing Date 18.09.2020
IPC
C07K 1/22 2006.01
CCHEMISTRY; METALLURGY
07ORGANIC CHEMISTRY
KPEPTIDES
1General processes for the preparation of peptides
14Extraction; Separation; Purification
16by chromatography
22Affinity chromatography or related techniques based upon selective absorption processes
C07K 16/18 2006.01
CCHEMISTRY; METALLURGY
07ORGANIC CHEMISTRY
KPEPTIDES
16Immunoglobulins, e.g. monoclonal or polyclonal antibodies
18against material from animals or humans
C07K 16/22 2006.01
CCHEMISTRY; METALLURGY
07ORGANIC CHEMISTRY
KPEPTIDES
16Immunoglobulins, e.g. monoclonal or polyclonal antibodies
18against material from animals or humans
22against growth factors
C07K 16/32 2006.01
CCHEMISTRY; METALLURGY
07ORGANIC CHEMISTRY
KPEPTIDES
16Immunoglobulins, e.g. monoclonal or polyclonal antibodies
18against material from animals or humans
32against translation products from oncogenes
C07K 16/36 2006.01
CCHEMISTRY; METALLURGY
07ORGANIC CHEMISTRY
KPEPTIDES
16Immunoglobulins, e.g. monoclonal or polyclonal antibodies
18against material from animals or humans
36against blood coagulation factors
C07K 16/00 2006.01
CCHEMISTRY; METALLURGY
07ORGANIC CHEMISTRY
KPEPTIDES
16Immunoglobulins, e.g. monoclonal or polyclonal antibodies
Applicants
  • MERCK SHARP & DOHME CORP. [US]/[US] (AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BE, BF, BG, BH, BJ, BN, BR, BW, BY, BZ, CA, CF, CG, CH, CI, CL, CM, CN, CO, CR, CU, CY, CZ, DE, DJ, DK, DM, DO, DZ, EC, EE, EG, ES, FI, FR, GA, GB, GD, GE, GH, GM, GN, GQ, GR, GT, GW, HN, HR, HU, ID, IE, IL, IN, IR, IS, IT, JO, JP, KE, KG, KH, KM, KN, KP, KR, KW, KZ, LA, LC, LK, LR, LS, LT, LU, LV, LY, MA, MC, MD, ME, MG, MK, ML, MN, MR, MT, MW, MX, MY, MZ, NA, NE, NG, NI, NL, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, SD, SE, SG, SI, SK, SL, SM, SN, ST, SV, SY, SZ, TD, TG, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, UZ, VC, VN, WS, ZA, ZM, ZW)
  • CHMIELOWSKI, Rebecca, A. [US]/[US] (US)
  • INSAIDOO, Francis [US]/[US] (US)
  • MILLER, Justin, B. [US]/[US] (US)
  • SHAH, Darshini [US]/[US] (NZ, US)
  • ROUSH, David, J. [US]/[US] (US)
  • WELSH, John, P. [US]/[US] (US)
Inventors
  • CHMIELOWSKI, Rebecca, A.
  • INSAIDOO, Francis
  • MILLER, Justin, B.
  • SHAH, Darshini
  • ROUSH, David, J.
  • WELSH, John, P.
Common Representative
  • MERCK SHARP & DOHME CORP.
Priority Data
62/904,33123.09.2019US
Publication Language English (EN)
Filing Language English (EN)
Designated States
Title
(EN) METHODS AND COMPOSITIONS COMPRISING AN ANTI-CTLA4 MONOCLONAL ANTIBODY WITH REDUCED HOST CELL PROTEINS AND INCREASED POLYSORBATE-80 STABILITY
(FR) MÉTHODES ET COMPOSITIONS COMPRENANT UN ANTICORPS MONOCLONAL ANTI-CTLA4 COMPORTANT DES PROTÉINES DE CELLULES HÔTES RÉDUITES ET À STABILITÉ ACCRUE DE POLYSORBATE-80
Abstract
(EN)
Provided herein are methods of separating host cell lipases from a production protein in chromatographic processes and methods of improving polysorbate-80 stability in a production protein formulation by separating host cell lipases from the production protein using chromatographic processes. Also provided herein are compositions comprising antibodies or antigen binding fragments thereof that bind to cytotoxic T lymphocyte associated antigen 4 (CTLA4). In another aspect, such compositions further comprise a reduced level of host cell proteins and/or increased level of polysorbate-80 (PS-80) stability.
(FR)
L'invention concerne des procédés de séparation de lipases de cellules hôtes d'une protéine de production lors de processus chromatographiques et des procédés d'amélioration de la stabilité du polysorbate-80 dans une formulation de protéines de production en séparant les lipases de cellules hôtes de la protéine de production à l'aide de processus chromatographiques. L'invention concerne également des compositions comprenant des anticorps ou leurs fragments de liaison à l'antigène qui se lient à l'antigène 4 associé aux lymphocytes T cytotoxiques (CTLA4). Selon un autre aspect, de telles compositions comprennent en outre un niveau réduit de protéines de cellules hôtes et/ou un niveau accru de stabilité du polysorbate-80 (PS-80).
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