{"id":3262,"date":"2024-03-06T06:06:03","date_gmt":"2024-03-06T06:06:03","guid":{"rendered":"https:\/\/longchangextracts.com\/?p=2970"},"modified":"2024-03-06T06:06:03","modified_gmt":"2024-03-06T06:06:03","slug":"__trashed-2","status":"publish","type":"post","link":"https:\/\/longchangextracts.com\/da\/__trashed-2\/","title":{"rendered":"Hvordan kan en effektiv produktionsproces med kontinuerligt flow anvendes i biofarmaceutiske produkter?"},"content":{"rendered":"

Hvordan kan en effektiv produktionsproces med kontinuerligt flow anvendes i biofarmaceutiske produkter?<\/strong><\/h1>\n

Forskning og udvikling i dannelse af l\u00e6gemiddelkrystaller<\/p>\n

I \u00f8jeblikket vokser den biofarmaceutiske industri hurtigt, is\u00e6r med stigningen i upstream-ekspression og opskalering. Konventionel batch-produktion er af begr\u00e6nset effektivitet, mens kontinuerlig flow-produktion viser lovende anvendelser med hensyn til \u00f8get kapacitet, omkostningsreduktion og tidsreduktion.<\/p>\n

Baggrund<\/p>\n

Kinas biofarmaceutiske industri er lige startet, og kinesiske l\u00e6gemiddelvirksomheder har et stort forspring i forhold til udenlandske biofarmaceutiske giganter, b\u00e5de n\u00e5r det g\u00e6lder teknologiniveau, produktionsskala og effektivitet. Hvis de stadig f\u00f8lger batchproduktionsmetoden for udenlandske originalpr\u00e6parater, vil de ikke have nogen fordel i produktionsomkostningerne og vil v\u00e6re i en ufordelagtig position i udbuddet af b\u00e5ndindk\u00f8b. For at vinde i den h\u00e5rde konkurrence skal kinesiske biofarmaceutiske virksomheder derfor have en bedre produktionsproces, h\u00f8jere produktionseffektivitet og lavere produktionsomkostninger end de oprindelige l\u00e6gemiddelproducenter. Anvendelsen af kontinuerlig produktionsteknologi vil v\u00e6re et gennembrud for kinesiske biofarmaceutiske virksomheder for at opn\u00e5 en konkurrencem\u00e6ssig fordel. Kontinuerlig produktionsteknologi er lige startet, og indenlandske og udenlandske virksomheder er stort set p\u00e5 samme startlinje. Hvis kinesiske biosimil\u00e6re virksomheder kan gribe muligheden for at prioritere udviklingen og brugen af kontinuerlig produktionsteknologi, vil de v\u00e6re i stand til at drage fordel af den sene komforts fordel ved at forbedre produktionseffektiviteten og s\u00e6nke produktionsomkostningerne.<\/p>\n

Traditionel produktion af biologiske l\u00e6gemidler bruger en batchproduktionsproces, som kr\u00e6ver en r\u00e6kke intervaller af produktionstrin. Hvert intervalltrin i hele processen vil medf\u00f8re en reduktion og forsinkelse i produktionseffektiviteten og \u00f8ge sandsynligheden for produktfejl og driftsfejl. Kontinuerlig produktion af farmaceutisk teknologi er en ny teknologi, der stadig st\u00e5r over for mange lovgivningsm\u00e6ssige sp\u00f8rgsm\u00e5l og teknologiske udfordringer, men overlegenheden ved kontinuerlig produktion er indlysende og en generel tendens i udviklingen af biofarmaceutiske processer, som kan forbedre produktionsprocessens robusthed og p\u00e5lidelighed, reducere udgifterne til produktion og anl\u00e6gsaktiver, reducere anl\u00e6gstiden og reducere den tid, der kr\u00e6ves til produktskift i produktionen.<\/p>\n

I den efterf\u00f8lgende produktionsproces sker implementeringen af kontinuerligt flow hovedsageligt ved brug af kontinuerlig flowkromatografi, onlinetestning og andre teknologier til at integrere flere procesenheder (figur 1), hvilket kan forbedre produktionseffektiviteten og anl\u00e6gsudnyttelsen, samtidig med at mellemlagring, ventetid mellem trin og omfanget af instrumentering og tilsvarende input reduceres for at n\u00e5 m\u00e5let om at forkorte cyklustiden og s\u00e6nke produktionsomkostningerne. M\u00e5let er at forkorte produktionscyklussen og reducere produktionsomkostningerne.<\/p>\n

\"\"<\/p>\n

Casestudie<\/p>\n

Hvad ang\u00e5r downstream-rensningsprocessen, best\u00e5r den hovedsageligt af f\u00f8lgende: Det f\u00f8rste trin involverer indfangning af antistoffet med Protein A-affinitetsmedier; det andet trin bruger kationkromatografi som en mellemliggende rensning til at fjerne antistofpolymerer, HCP, DNA osv.; og det tredje trin bruger anionkromatografimedier til fint at adskille resterende DNA, HCP, Protein A, endotoksin osv. for at opn\u00e5 form\u00e5let med rensning (figur 2). Det tredje trin er den fine adskillelse af resterende DNA, HCP, protein A, endotoksin og andre urenheder ved hj\u00e6lp af anionkromatografimedium for at opn\u00e5 rensning (figur 2).<\/p>\n

\"\"<\/p>\n

Hovedform\u00e5let med downstream-rensningsprocessen er at \u00f8ge produktets renhed og udbytte gennem separation og rensning og at garantere produktets kvalitet og stabilitet. Kontinuerlig produktion kr\u00e6ver sammenkobling af alle trin, s\u00e5 produktionsprocessen kan blive meget integreret og automatiseret, og for at sikre produktstabilitet og -konsistens osv. (figur 3).<\/p>\n

\"\"<\/p>\n

Den kontinuerlige flowproces kan forbedre fyldstofudnyttelsen, reducere procestiden og \u00f8ge kapaciteten (figur 4). Anvendelsen af den kontinuerlige flowproces vil blive beskrevet i flere casestudier nedenfor.<\/p>\n

\"\"<\/p>\n

 <\/p>","protected":false},"excerpt":{"rendered":"

How can an efficient continuous flow manufacturing process be applied in biopharmaceuticals? Drug Crystal Formation Research and Development Currently, the biopharmaceutical industry is growing rapidly, especially with the increase in upstream expression and scale-up. Conventional batch production is of limited efficiency, while continuous flow production shows promising applications in terms of increased capacity, cost reduction […]<\/p>","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[20],"tags":[],"yoast_head":"\nHow can an efficient continuous flow manufacturing process be applied in biopharmaceuticals? - China Chemical Manufacturer<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/longchangextracts.com\/da\/__trashed-2\/\" \/>\n<meta property=\"og:locale\" content=\"da_DK\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"How can an efficient continuous flow manufacturing process be applied in biopharmaceuticals? - China Chemical Manufacturer\" \/>\n<meta property=\"og:description\" content=\"How can an efficient continuous flow manufacturing process be applied in biopharmaceuticals? 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