Postopek proizvodnje rekombinantnega človeškega kolagena

• Izkoriščanje naprednih tehnik bioproizvodnje za proizvodnjo kolagena

  Yaohai je za Yaohai razvil proizvodni proces, ki uporablja kvas kot živi stroj, kar je eden najbolj inovativnih načinov. V tem primeru so celice kvasovk zasnovane tako, da izločajo aminokisline, ki so bistvene za izgradnjo človeškega kolagena. Te celice kvasovk gojijo v velikih kadeh, znanih kot bioreaktorji, kjer proizvajajo beljakovine kolagena. Fermentacija, ki je trenutno zelo hiter proces, da bi kolagen prišel na trg hitro in poceni. Skozi to Proizvodnja rekombinantnega insulina metoda, Yaohai lahko opravi zahtevo kolagena in to sans s'agit de rares ressources naturelles.  

• Ključni premisleki in izzivi pri proizvodnji rekombinantnega kolagena

  Pri ustvarjanju rekombinantnega človeškega kolagena je treba upoštevati več stvari. Največja ovira: Razvijte proizvedeni kolagen tako, da bo tako dober kot naraven. Torej moraš biti ves čas fermentacijske epizode pozoren, da stvari ostanejo enakomerne. Poleg tega sta pomembna tudi čiščenje in prečiščevanje končnega izdelka. Ta kolagen se nato predela v potrošniško blago in se na splošno proizvaja po visokih standardih. To pomeni, da je treba te postopke in ukrepe pogosto preverjati, tako da so proizvedeni varni, čisti in osredotočeni na kakovost.  

• Vloga rekombinantnega kolagena v tkivnem inženirstvu in regenerativni medicini

  Rekombinantni človeški kolagen je pomemben temelj na medicinskem področju. Sčasoma raziskovalci upajo, da bi ta material lahko služil kot oder za gojenje novega tkiva in situ. The Bioproizvodnja rekombinantne mutacije insulina also can work as a vessel to carry medicine where it needs to go. That would seem to be the answer, human cells make the reinnovative collagen, so that the body will reject it and get sick due to its presence. Collagen is widely used in cartilage, bone and skin repairs, so Recombinant collagen. It is also widely used in drug delivery system, which makes it a very  target for medical intervention.   

Zakaj izbrati proces proizvodnje rekombinantnega človeškega kolagena Yaohai?

• Sistem kakovosti in globalna skladnost s predpisi

  Yaohai BioPharma is a Top 10 Microbial CDMO that incorporates quality control and Recombinant Human Collagen Production Process. We have developed a solid quality system that adheres to current GMP standards and regulatory requirements worldwide. Our regulatory team is knowledgeable on global regulatory frameworks to expedite biological launches. We make sure that production processes are traceable with high-quality products as well as complying with the rules of the US FDA and EU EMA. Australia TGA and China NMPA are also in compliance. Yaohai BioPharma successfully passed an on-site audit conducted by a Qualified Person from the European Union (QP) to examine our GMP process and manufacturing facility. We also successfully been through the initial certification audits of the ISO9001 Quality Management System and ISO14001 Environmental Management System.

• Prilagoditev, učinkovitost in stroškovna učinkovitost

  Yaohai Bio-Pharma is experienced in the development of microbial-derived biologics We offer tailored RD solutions and manufacturing while keeping risks to a minimum We have used a variety of modalities including recombinant subunits vaccines (including peptides) growth factors hormones and Cytokines We've specialized in several microorganisms like yeast intracellular and extracellular secretion (yields up to 15g/L) and bacteria intracellular soluble and inclusion body (yields as high as 10g/L) We have also created a Recombinant Human Collagen Production Process fermentation system to develop bacteria-based vaccines We are experts in optimizing processes increasing yields as well as reducing production costs Utilizing a strong technology team we ensure timely and quality project delivery to bring your exclusive products to market faster

• Strokovno znanje in bogate izkušnje

  Yaohai Bio-Pharma, vodilna družba CDMO mikrobnih bioloških zdravil, ima sedež v Jiangsuju. Osredotočeni smo bili na mikrobiološko proizvedene terapevtike in cepiva, ki so primerna za ljudi, veterinarje in upravljanje procesa proizvodnje rekombinantnega človeškega kolagena. Imamo najnaprednejše RD kot tudi proizvodne tehnološke platforme, ki pokrivajo celoten proces od inženiringa mikrobnih sevov, celičnega bančništva ter razvoja procesov in metod do komercialne in klinične proizvodnje, kar zagotavlja uspešno dobavo najnaprednejših rešitve. Nabrali smo ogromno izkušenj z biopredelavo mikrobnih celic. Izvedli smo več kot 200 projektov po vsem svetu in našim strankam pomagali pri krmarjenju s pravili in predpisi ameriške FDA, EU EMA, avstralske TGA in kitajske NMPA. Naše strokovno znanje in bogate izkušnje nam omogočajo, da se hitro prilagajamo potrebam trga in nudimo prilagojene CDMO storitve.

• Robustna dobavna veriga in proizvodne zmogljivosti

  Yaohai Bio-Pharma is a Top 10 biological company that specializes in Recombinant Human Collagen Production Process. We have built a modern manufacturing facility with robust RD capabilities and modern manufacturing facilities. Five drug substance production lines complying with GMP standards for microbial fermentation and purification along with two fill and final lines for vials and cartridges as well as pre-filled needles are readily available. The available fermentation scales vary between 100L and 2000L. The filling volume ranges from 1ml up to 25ml. Syringes or cartridges that are pre-filled are filled with 3 to 3.5ml. Our production workshop that is cGMP-compliant ensures constant supply of clinical sample and commercial products. Our facility produces large molecules that are exported to all over the world.

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