nūhou

Ka ʻike ʻana i kahi Leachable Oxidizing mai kahi pahu pahu lāʻau lapaʻau

Hoʻohana nui ʻia nā mea polymeric hoʻohana hoʻokahi i nā ʻano hana hana biopharmaceutical.Hiki ke hoʻopili ʻia kēia i kā lākou laulā o nā noi a me ka maʻalahi e pili ana a me ka hoʻololi ʻana, a me kā lākou mau kumukūʻai haʻahaʻa a no ka mea ʻaʻole koi ʻia kahi hōʻoia hoʻomaʻemaʻe.[1][2]

ʻO ka mea maʻamau, ma lalo o nā kūlana hoʻohana maʻamau, ʻo ka neʻe ʻana i nā pūhui kemika i kapa ʻia ʻo "leachables," aʻo nā pūhui e neʻe ana ma lalo o nā kūlana ʻoihana hoʻonui i kapa ʻia ʻo "extractables."ʻO ka loaʻa ʻana o nā leachable ka mea e hopohopo nui ai e pili ana i ka ʻoihana lapaʻau, no ka mea, ʻoi aku ka maʻalahi o nā protein therapeutic i ka hoʻololi ʻana i ka hoʻololi ʻana i hiki ke hana ʻia ma muli o ka hiki ʻana mai o nā mea haumia, inā loaʻa ia mau mea i nā pūʻulu hana.[3][4]Hiki ke noʻonoʻo ʻia ka hoʻolele ʻana mai nā mea hoʻokele waiwai, ʻoiai ʻaʻole lōʻihi ka lōʻihi o ka hoʻopili ʻana i ka hoʻohālikelike ʻana i ka mālama ʻana i ka huahana no ka wā lōʻihi.[5]
E pili ana i nā koi hoʻoponopono, ʻōlelo ka US Code of Federal Regulations Title 21 ʻaʻole e hoʻololi nā lako hana [6] a me nā pani pahu [7] i ka palekana, ka maikaʻi a i ʻole ka maʻemaʻe o kahi lāʻau.No laila a i mea e hōʻoia ai i ka maikaʻi o ka huahana a me ka palekana o ka poʻe maʻi, ʻo ka loaʻa ʻana o kēia mau mea haumia, i loaʻa mai ka nui o nā mea pili DP, pono e nānā ʻia a mālama ʻia i nā hana hana āpau, i ka wā o ka hana ʻana, mālama a me ka hoʻokele hope.
Ma muli o ka helu ʻia ʻana o nā mea hoʻokele e like me nā lāʻau lapaʻau, hoʻoholo a loiloi pinepine nā mea hoʻolako a me nā mea hana i ka hiki ʻana mai o nā migrants kemika e like me ka manaʻo o ka hoʻohana ʻana o kahi huahana, no ka laʻana, no nā ʻeke infusion, ʻo ka hopena wai wale nō i loaʻa, e laʻa, 0.9% (w. /v) NaCl, nānā ʻia.Eia naʻe, ua hōʻike mua ʻia e hiki ke hoʻololi a hoʻonui i ka neʻe ʻana o nā pūhui non-polar i ka hoʻohālikelike ʻana i nā mea hoʻonā wai maʻalahi.[7][8] ]
No laila, ʻo ia ka pahuhopu o ka papahana o kēia manawa e ʻike i nā mea hoʻoheheʻe ʻia mai kahi syringe lapaʻau maʻamau.No laila, hana mākou i nā haʻawina leachable i hoʻohana ʻia me ka hoʻohana ʻana i ka wai 0.1% (w/v) PS20 ma ke ʻano he DP surrogate solution.Ua kālailai ʻia nā haʻina leachables i loaʻa e nā mea unuhi maʻamau a me nā ʻano analytical leachables.Ua wehe ʻia nā ʻāpana syringe e ʻike i ke kumu hoʻokuʻu leachable mua.[9]
I ka wā o ka hoʻohana ʻana i nā leachables noiʻi e pili ana i ka syringe hoʻohana hoʻohana ʻia a me ka CE-certified disposable administration syringe, ua ʻike ʻia kahi pūhui kemika carcinogenic41, ʻo ia hoʻi, ʻo 1,1,2,2-tetrachloroethane i nā ʻike ma luna o ka paepae loiloi analytical mai ICH M7 (AET). ).Ua hoʻomaka ʻia kahi hoʻokolokolo hoʻopaʻapaʻa e ʻike i ka pahu pahu pahu i loko o ke kumu kumu TCE.[10]
ʻOiaʻiʻo, hiki iā mākou ke hōʻike maopopo ʻaʻole ʻo TCE he leachable mai ka pahu pahu.Eia hou, ua hōʻike ʻia ka hoʻokolohua ʻana i kahi pūhui i ʻike ʻole ʻia me nā waiwai oxidizing e lele ana mai ka pahu pahu, hiki ke hoʻokahe i ka DCM i TCE.[11]
I mea e ʻike ai i ka hui leaching, ua ʻike ʻia ka pahu pahu a me kāna ʻāpana me nā ʻano analytical methodologies. ʻO nā peroxide organik ʻokoʻa, hiki ke hoʻohana ʻia e like me ka polymerization initiators i ka wā o ka hana ʻana i ka plastic， nā mea i noiʻi ʻia no ko lākou hiki ke hoʻokahe i ka DCM i TCE. No ka hōʻoia maopopo ʻana o ka ʻōnaehana Luperox⑧ 101 paʻa e like me ka pūhui leachable oxidizing, ua hana ʻia ka loiloi NMR.Ua hoʻoheheʻe ʻia kahi ʻāpana methanolic rubber a me kahi methanolic Luperox 101 reference standard a maloʻo.Hoʻohui hou ʻia nā koena i ka methanol-d4 a nānā ʻia e NMR.ʻO ka polymerization initiator Luperox⑧101 ua hōʻoia ʻia ʻo ia ka leachable oxidizing o ka pahu pahu syringe hoʻopau.[12]
Me ka haʻawina i hōʻike ʻia ma ʻaneʻi, manaʻo nā mea kākau e hoʻonui i ka ʻike e pili ana i ka pono leaching kemika mai nā mea hoʻokele i hoʻohana ʻia i ke kino, e pili ana i ka loaʻa ʻana o nā kemika leaching "ʻike ʻole ʻia" akā ikaika loa.ʻO ka nānā ʻana i ka TCE he ala maʻalahi a maʻalahi hoʻi e nānā i ka maikaʻi o ka DP ma nā ʻanuʻu hana āpau a laila e kōkua i ka palekana o nā maʻi.[13]

Nā kuhikuhi

[1] Shukla AA, Gottschalk U. Nā ʻenehana hoʻohana hoʻokahi no ka hana biopharmaceutical.Nā Kūlana Biotechnol.2013;31(3):147-154.

[2] Lopes AG.Hoʻohana hoʻokahi i ka ʻoihana biopharmaceutical: kahi loiloi o ka hopena tech-nology o kēia manawa, nā pilikia a me nā palena.Kaʻina Hana Bioprod Meaʻai.2015;93:98-114.

[3] Paskiet D, Jenke D, Ball D, Houston C, Norwood DL, Markovic I. ʻO ka Product QualityResearch Institute (PQRI) leaachables and extractable working group initiatives forparenteral and ophthalmic drug product (PODP).PDA ] Pharm Sci Technol.2013;67(5):430-447.

[4] Wang W, Ignatius AA, Thakkar SV.Ka hopena o nā koena haumia a me nā mea haumia i ka paʻa o ka protein.J Pharmaceut Sci.2014;103(5):1315-1330.

[5] Paudel K, Hauk A, Maier TV, Menzel R. ʻO ke ʻano o ka nui o nā leachable e hāʻule i loko o ka hana biopharmaceutical downstream.Eur J Pharmaceut Sci.2020;143: 1 05069.

[6] ʻAmelika Hui Pū ʻIa a me ʻAmelika Hui Pū ʻIa FDA.21 CFR Sec.211.65, Ka hana lako.Hoʻoponopono hou ʻia mai ʻApelila 1, 2019.

[7] ʻAmelika Hui Pū ʻIa a me ʻAmelika Hui Pū ʻIa FDA.21 CFR Sec.211.94, Nā pahu huahana lāʻau a me nā pani.Hoʻoponopono hou ʻia mai ʻApelila 1, 2020.

[8] Jenke DR.[Appl Polvmer Sci.2003:89(4):1049- 1057.

[9] Pūʻulu Hana BioPhorum BPOG.ʻO ke alakaʻi hoʻomaʻamaʻa maikaʻi loa no ka hoʻāʻo ʻana i nā mea hoʻohana hoʻokahi polymeric i hoʻohana ʻia i ka hana biopharmaceutical.BioPhorum Operations Group Ltd (paʻi pūnaewele);2020.

[10] Khan TA, Mahler HC, Kishore RS.ʻO nā pilina koʻikoʻi o nā surfactants i nā formulations protein therapeutic: kahi loiloi.FurJ Pharm Riopharm.2015;97(Pt A):60- -67.

[11] Ke Keʻena Ola Ola a me nā lawelawe kanaka o ʻAmelika Hui Pū ʻIa, Food and Drug Administration FDA, Center for Drug Evaluation and Research CDER, Center for BiologicsEvaluation and Reseach CBER.Ke alakaʻi no ka ʻoihana - ka loiloi immunogenicity

[12] Bee JS, Randolph TW, Kamana JF, Bishop SM, Dimitrova MN.Nā hopena o nā ʻili a me nā leachable i ka paʻa o nā biopharmaceuticals.J Pharmaceut Sci.2011;100 (10):4158- -4170.

[13] Kishore RS, Kiese S, Fischer S, Pappenberger A, Grauschopf U, Mahler HC.ʻO ka hoʻohaʻahaʻa o polysorbates 20 a me 80 a me kona hopena kūpono i ka paʻa o nā biotherapeutics.Pharm Res.2011;28(5):1194-1210.