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1. (WO2007014073) CONCENTRATED PROTEIN LYOPHILATES, METHODS, AND USES
Latest bibliographic data on file with the International Bureau   

Pub. No.:    WO/2007/014073    International Application No.:    PCT/US2006/028476
Publication Date: 01.02.2007 International Filing Date: 20.07.2006
IPC:
A61K 39/395 (2006.01), A61K 9/19 (2006.01), C07K 16/46 (2006.01)
Applicants: AMGEN INC. [US/US]; Mail Stop 28-2-C, One Amgen Center Drive, Thousand Oaks, California 91320-1799 (US) (For All Designated States Except US).
KRISHNAN, Sampathkumar [IN/US]; (US) (For US Only).
PALLITTO, Monica [US/US]; (US) (For US Only).
NAGLE, Samantha [US/US]; (US) (For US Only).
CRAMPTON, Shon Lee [US/US]; (US) (For US Only).
RICCI, Margaret Speed [US/US]; (US) (For US Only).
CAO, Wenjin [US/US]; (US) (For US Only).
LIN, Hong [CN/US]; (US) (For US Only).
XIE, Yong [CN/US]; (US) (For US Only)
Inventors: KRISHNAN, Sampathkumar; (US).
PALLITTO, Monica; (US).
NAGLE, Samantha; (US).
CRAMPTON, Shon Lee; (US).
RICCI, Margaret Speed; (US).
CAO, Wenjin; (US).
LIN, Hong; (US).
XIE, Yong; (US)
Agent: REINECKE, Raz; Amgen Inc., One Amgen Center Drive, Mail Stop 28-2-C, Thousand Oaks, CA 91320-1799 (US)
Priority Data:
60/702,025 22.07.2005 US
Title (EN) CONCENTRATED PROTEIN LYOPHILATES, METHODS, AND USES
(FR) LYOPHILISATS PROTEIQUES CONCENTRES, PROCEDES ASSOCIES ET LEURS UTILISATIONS
Abstract: front page image
(EN)The invention provides, among other things, lyophilized compositions of high surface area that comprise a protein and that reconstitute quickly and efficiently to solution of high protein concentration with minimal formation, if any, of foam, effervescence, bubbles, turbidity, or particulates that might be deleterious. The invention also provides, among other things, methods for making the lyophilized compositions. The invention in additional aspects also provides Raman Imaging Spectrographic methods for real time analyses of polymorphs in a sample using PLS algorithms. By way of particular example, the use of the method for the analysis of mannitol polymorphs is described, and the use of the analysis to determine optimum compositions and lyophilization methods for producing lyophilates of pharmaceutical proteins having a predefined distribution of mannitol polymorphs and having the aforementioned reconstitution properties is also described.
(FR)L'invention concerne, entre autres, des compositions lyophilisées à surface active étendue renfermant une protéine et se reconstituant rapidement et efficacement en une solution de haute concentration protéique avec une formation minimale, voire nulle, de mousse, d'effervescence, de bulles, de turbidité ou de particules indésirables. L'invention concerne également, entre autres, des procédés de production de ces compositions lyophilisées. Dans des aspects additionnels, l'invention concerne des procédés spectrographiques d'imagerie Raman destinés à l'analyse en temps réel de polymorphes dans un échantillon au moyen d'algorithmes PLS. A travers un exemple particulier, on décrit l'utilisation du procédé pour l'analyse de polymorphes de mannitol ainsi que l'utilisation de cette analyse pour déterminer des compositions et des procédés de lyophilisation optimaux pour produire des lyophilisats de protéines pharmaceutiques présentant une distribution prédéfinie de polymorphes de mannitol et présentant les propriétés de reconstitution susmentionnées.
Designated States: AE, AG, AL, AM, AT, AU, AZ, BA, BB, BG, BR, BW, BY, BZ, CA, CH, CN, CO, CR, CU, CZ, DE, DK, DM, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, KR, KZ, LA, LC, LK, LR, LS, LT, LU, LV, LY, MA, MD, MG, MK, MN, MW, MX, MZ, NA, NG, NI, NO, NZ, OM, PG, PH, PL, PT, RO, RS, RU, SC, SD, SE, SG, SK, SL, SM, SY, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW.
African Regional Intellectual Property Organization (BW, GH, GM, KE, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, ZM, ZW)
Eurasian Patent Organization (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM)
European Patent Office (AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HU, IE, IS, IT, LT, LU, LV, MC, NL, PL, PT, RO, SE, SI, SK, TR)
African Intellectual Property Organization (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, ML, MR, NE, SN, TD, TG).
Publication Language: English (EN)
Filing Language: English (EN)