{"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\/hu\/__trashed-2\/","title":{"rendered":"Hogyan alkalmazhat\u00f3 a hat\u00e9kony, folyamatos \u00e1raml\u00e1s\u00fa gy\u00e1rt\u00e1si folyamat a biofarm\u00e1cia ter\u00fclet\u00e9n?"},"content":{"rendered":"

Hogyan alkalmazhat\u00f3 a hat\u00e9kony, folyamatos \u00e1raml\u00e1s\u00fa gy\u00e1rt\u00e1si folyamat a biofarm\u00e1cia ter\u00fclet\u00e9n?<\/strong><\/h1>\n

Gy\u00f3gyszerkrist\u00e1lyok kialakul\u00e1s\u00e1nak kutat\u00e1sa \u00e9s fejleszt\u00e9se<\/p>\n

Jelenleg a biofarm\u00e1ciai ipar gyorsan n\u00f6vekszik, k\u00fcl\u00f6n\u00f6sen az upstream expresszi\u00f3 \u00e9s a m\u00e9retn\u00f6vel\u00e9s n\u00f6veked\u00e9s\u00e9vel. A hagyom\u00e1nyos szakaszos gy\u00e1rt\u00e1s korl\u00e1tozott hat\u00e9konys\u00e1g\u00fa, m\u00edg a folyamatos \u00e1raml\u00e1s\u00fa gy\u00e1rt\u00e1s \u00edg\u00e9retes alkalmaz\u00e1sokat mutat a kapacit\u00e1sn\u00f6vel\u00e9s, a k\u00f6lts\u00e9gcs\u00f6kkent\u00e9s \u00e9s az id\u0151cs\u00f6kkent\u00e9s szempontj\u00e1b\u00f3l.<\/p>\n

H\u00e1tt\u00e9r<\/p>\n

A k\u00ednai biofarm\u00e1ciai ipar m\u00e9g csak most indult, \u00e9s a k\u00ednai gy\u00f3gyszeripari v\u00e1llalatoknak nagy a lemarad\u00e1suk a k\u00fclf\u00f6ldi biofarm\u00e1ciai \u00f3ri\u00e1sokhoz k\u00e9pest mind a technol\u00f3giai szint, mind a gy\u00e1rt\u00e1si m\u00e9ret \u00e9s hat\u00e9konys\u00e1g tekintet\u00e9ben. Ha tov\u00e1bbra is a k\u00fclf\u00f6ldi origin\u00e1lis gy\u00f3gyszerek t\u00e9teles gy\u00e1rt\u00e1si m\u00f3dj\u00e1t k\u00f6vetik, akkor nem lesznek el\u0151nyben a gy\u00e1rt\u00e1si k\u00f6lts\u00e9gek ter\u00e9n, \u00e9s h\u00e1tr\u00e1nyos helyzetbe ker\u00fclnek a s\u00e1vos beszerz\u00e9sre vonatkoz\u00f3 licit\u00e1l\u00e1s sor\u00e1n. Ez\u00e9rt az \u00e9les versenyben val\u00f3 gy\u0151zelem \u00e9rdek\u00e9ben a k\u00ednai biofarm\u00e1ciai v\u00e1llalatoknak jobb gy\u00e1rt\u00e1si elj\u00e1r\u00e1ssal, nagyobb gy\u00e1rt\u00e1si hat\u00e9konys\u00e1ggal \u00e9s alacsonyabb gy\u00e1rt\u00e1si k\u00f6lts\u00e9gekkel kell rendelkezni\u00fck, mint az origin\u00e1lis gy\u00f3gyszergy\u00e1rt\u00f3knak. A folyamatos gy\u00e1rt\u00e1si technol\u00f3gia alkalmaz\u00e1sa \u00e1tt\u00f6r\u00e9st jelent majd a k\u00ednai biofarm\u00e1ciai v\u00e1llalatok sz\u00e1m\u00e1ra, hogy versenyel\u0151nyre tegyenek szert. A folyamatos gy\u00e1rt\u00e1si technol\u00f3gia m\u00e9g csak most indult el, \u00e9s a hazai \u00e9s a k\u00fclf\u00f6ldi v\u00e1llalatok alapvet\u0151en ugyanazon a startvonalon \u00e1llnak. Ha a k\u00ednai biohasonl\u00f3 v\u00e1llalatok meg tudj\u00e1k ragadni a lehet\u0151s\u00e9get, hogy priorit\u00e1sk\u00e9nt kezelj\u00e9k a folyamatos gy\u00e1rt\u00e1si technol\u00f3gia fejleszt\u00e9s\u00e9t \u00e9s alkalmaz\u00e1s\u00e1t, akkor k\u00e9pesek lesznek kihaszn\u00e1lni a k\u00e9s\u0151n \u00e9rkez\u0151 v\u00e1llalatok el\u0151ny\u00e9t a gy\u00e1rt\u00e1si hat\u00e9konys\u00e1g jav\u00edt\u00e1s\u00e1ban \u00e9s a gy\u00e1rt\u00e1si k\u00f6lts\u00e9gek cs\u00f6kkent\u00e9s\u00e9ben.<\/p>\n

A hagyom\u00e1nyos biogy\u00f3gyszer-gy\u00e1rt\u00e1s szakaszos gy\u00e1rt\u00e1si folyamatot alkalmaz, amely a gy\u00e1rt\u00e1si l\u00e9p\u00e9sek sorozatos id\u0151k\u00f6z\u00f6nk\u00e9nt t\u00f6rt\u00e9n\u0151 elv\u00e9gz\u00e9s\u00e9t ig\u00e9nyli. A teljes folyamat minden egyes intervallumos l\u00e9p\u00e9se a gy\u00e1rt\u00e1si hat\u00e9konys\u00e1g cs\u00f6kken\u00e9s\u00e9vel \u00e9s k\u00e9sedelm\u00e9vel j\u00e1r, \u00e9s n\u00f6veli a term\u00e9khib\u00e1k \u00e9s a m\u0171k\u00f6d\u00e9si hib\u00e1k val\u00f3sz\u00edn\u0171s\u00e9g\u00e9t. A folyamatos gy\u00e1rt\u00e1s\u00fa gy\u00f3gyszertechnol\u00f3gia egy felt\u00f6rekv\u0151 technol\u00f3gia, amely m\u00e9g mindig sz\u00e1mos szab\u00e1lyoz\u00e1si k\u00e9rd\u00e9ssel \u00e9s technol\u00f3giai kih\u00edv\u00e1ssal n\u00e9z szembe, de a folyamatos gy\u00e1rt\u00e1s f\u00f6l\u00e9nye nyilv\u00e1nval\u00f3 \u00e9s \u00e1ltal\u00e1nos trend a biofarm\u00e1ciai folyamatok fejleszt\u00e9s\u00e9ben, amely jav\u00edthatja a gy\u00e1rt\u00e1si folyamat robusztuss\u00e1g\u00e1t \u00e9s megb\u00edzhat\u00f3s\u00e1g\u00e1t, cs\u00f6kkentheti a gy\u00e1rt\u00e1si \u00e9s \u00e1ll\u00f3eszk\u00f6z-kiad\u00e1sokat, cs\u00f6kkentheti az \u00fczem\u00e9p\u00edt\u00e9si id\u0151t \u00e9s cs\u00f6kkentheti a termel\u00e9sben a term\u00e9kv\u00e1lt\u00e1shoz sz\u00fcks\u00e9ges id\u0151t.<\/p>\n

A downstream termel\u00e9si folyamatban a folyamatos \u00e1raml\u00e1s megval\u00f3s\u00edt\u00e1sa els\u0151sorban a folyamatos \u00e1raml\u00e1s\u00fa kromatogr\u00e1fia, az on-line tesztel\u00e9s \u00e9s m\u00e1s technol\u00f3gi\u00e1k alkalmaz\u00e1s\u00e1val t\u00f6rt\u00e9nik t\u00f6bb folyamategys\u00e9g integr\u00e1l\u00e1sa \u00e9rdek\u00e9ben (1. \u00e1bra), ami jav\u00edthatja a termel\u00e9si hat\u00e9konys\u00e1got \u00e9s az \u00fczem kihaszn\u00e1lts\u00e1g\u00e1t, mik\u00f6zben cs\u00f6kkentheti a k\u00f6ztes t\u00e1rol\u00e1st, a l\u00e9p\u00e9sek k\u00f6z\u00f6tti v\u00e1rakoz\u00e1si id\u0151t, valamint a m\u0171szerek \u00e9s a megfelel\u0151 inputok m\u00e9ret\u00e9t, \u00edgy el\u00e9rheti a ciklusid\u0151 ler\u00f6vid\u00edt\u00e9s\u00e9nek \u00e9s a termel\u00e9si k\u00f6lts\u00e9gek cs\u00f6kkent\u00e9s\u00e9nek c\u00e9lj\u00e1t. A c\u00e9l a termel\u00e9si ciklus ler\u00f6vid\u00edt\u00e9se \u00e9s a termel\u00e9si k\u00f6lts\u00e9gek cs\u00f6kkent\u00e9se.<\/p>\n

\"\"<\/p>\n

Esettanulm\u00e1ny<\/p>\n

Ami a downstream tiszt\u00edt\u00e1si folyamatot illeti, az f\u0151k\u00e9nt a k\u00f6vetkez\u0151kb\u0151l \u00e1ll: az els\u0151 l\u00e9p\u00e9sben az antitestet Protein A affinit\u00e1s\u00fa k\u00f6zeggel fogj\u00e1k be; a m\u00e1sodik l\u00e9p\u00e9sben kationkromatogr\u00e1fi\u00e1t alkalmaznak k\u00f6ztes tiszt\u00edt\u00e1sk\u00e9nt az antitest polimerek, HCP, DNS stb. elt\u00e1vol\u00edt\u00e1s\u00e1ra; a harmadik l\u00e9p\u00e9sben pedig anionkromatogr\u00e1fi\u00e1s k\u00f6zeget haszn\u00e1lnak a marad\u00e9k DNS, HCP, Protein A, endotoxin stb. finom lev\u00e1laszt\u00e1s\u00e1ra a tiszt\u00edt\u00e1s c\u00e9lj\u00e1nak el\u00e9r\u00e9se \u00e9rdek\u00e9ben (2. \u00e1bra). A harmadik l\u00e9p\u00e9s a marad\u00e9k DNS, HCP, Protein A, endotoxin \u00e9s egy\u00e9b szennyez\u0151d\u00e9sek finom elv\u00e1laszt\u00e1sa anionkromatogr\u00e1fi\u00e1s k\u00f6zeggel a tiszt\u00edt\u00e1s el\u00e9r\u00e9se \u00e9rdek\u00e9ben (2. \u00e1bra).<\/p>\n

\"\"<\/p>\n

A tiszt\u00edt\u00e1si folyamat f\u0151 c\u00e9lja a term\u00e9k tisztas\u00e1g\u00e1nak \u00e9s hozam\u00e1nak n\u00f6vel\u00e9se az elv\u00e1laszt\u00e1s \u00e9s tiszt\u00edt\u00e1s r\u00e9v\u00e9n, valamint a term\u00e9k min\u0151s\u00e9g\u00e9nek \u00e9s stabilit\u00e1s\u00e1nak garant\u00e1l\u00e1sa. A folyamatos gy\u00e1rt\u00e1s megk\u00f6veteli az \u00f6sszes l\u00e9p\u00e9s \u00f6sszekapcsol\u00e1s\u00e1t, hogy a gy\u00e1rt\u00e1si folyamat nagym\u00e9rt\u00e9kben integr\u00e1lt \u00e9s automatiz\u00e1lt legyen, valamint a term\u00e9k stabilit\u00e1s\u00e1nak \u00e9s konzisztenci\u00e1j\u00e1nak biztos\u00edt\u00e1sa stb. \u00e9rdek\u00e9ben (3. \u00e1bra).<\/p>\n

\"\"<\/p>\n

A folyamatos \u00e1raml\u00e1si folyamat jav\u00edthatja a t\u00f6lt\u0151anyag-kihaszn\u00e1lts\u00e1got, cs\u00f6kkentheti a folyamat idej\u00e9t \u00e9s n\u00f6velheti a kapacit\u00e1st (4. \u00e1bra). A folyamatos \u00e1raml\u00e1si folyamat alkalmaz\u00e1s\u00e1t az al\u00e1bbiakban t\u00f6bb esettanulm\u00e1nyban ismertetj\u00fck.<\/p>\n

\"\"<\/p>\n

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

Hogyan alkalmazhat\u00f3 a hat\u00e9kony, folyamatos \u00e1raml\u00e1s\u00fa gy\u00e1rt\u00e1si folyamat a biofarm\u00e1cia ter\u00fclet\u00e9n? Gy\u00f3gyszerkrist\u00e1lyok kialakul\u00e1s\u00e1nak kutat\u00e1sa \u00e9s fejleszt\u00e9se Jelenleg a biofarm\u00e1ciai ipar gyorsan n\u00f6vekszik, k\u00fcl\u00f6n\u00f6sen az upstream expresszi\u00f3 \u00e9s a m\u00e9retn\u00f6vel\u00e9s n\u00f6veked\u00e9s\u00e9vel. A hagyom\u00e1nyos szakaszos gy\u00e1rt\u00e1s korl\u00e1tozott hat\u00e9konys\u00e1g\u00fa, m\u00edg a folyamatos \u00e1raml\u00e1s\u00fa gy\u00e1rt\u00e1s \u00edg\u00e9retes alkalmaz\u00e1sokat mutat a kapacit\u00e1s n\u00f6vel\u00e9se, a k\u00f6lts\u00e9gcs\u00f6kkent\u00e9s [...]<\/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\/hu\/__trashed-2\/\" \/>\n<meta property=\"og:locale\" content=\"hu_HU\" \/>\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? Drug Crystal Formation Research and Development Currently, the biopharmaceutical industry is growing rapidly, especially with the increase in upstream expression and scale-up. 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Drug Crystal Formation Research and Development Currently, the biopharmaceutical industry is growing rapidly, especially with the increase in upstream expression and scale-up. 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