Rekombinant humant kollagenproduktionsproces

• Udnyttelse af avancerede biofremstillingsteknikker til kollagenproduktion

  Yaohai har udviklet en produktionsproces for Yaohai, der bruger gær som en levende maskine, hvilket er en af ​​de mest innovative måder. I dette tilfælde konstruerede gærcellerne til at spytte de aminosyrer ud, der er nødvendige for at opbygge humant kollagen. Disse gærceller dyrkes i store kar kendt som bioreaktorer, hvor de udskiller kollagenproteinet. Fermentering, som er processen i høj kurs lige nu for at få kollagen på markedet hurtigt og billigt. Gennem dette Rekombinant insulinfremstilling metode, Yaohai kan gennemgå kollagen anmodning og at sans s'agit de rares ressources naturelles.  

• Nøgleovervejelser og udfordringer i rekombinant kollagenfremstilling

  Flere ting skal tages i betragtning, mens man skaber rekombinant humant kollagen. Største barriere: Udvikl det producerede kollagen til at være så godt som naturligt. Så du skal virkelig holde øje med fermenteringsepisoden for at holde tingene kørende. Yderligere er rensningen og oprensningen af ​​slutproduktet også væsentlig. Dette kollagen forarbejdes derefter til forbrugsvarer og er generelt fremstillet til en høj standard. Dette tyder på, at disse processer og foranstaltninger skal underkastes hyppige kontroller, så de fremstilles sikkert, rene og kvalitetsfokuserede.  

• Rollen af ​​rekombinant kollagen i vævsteknologi og regenerativ medicin

  Rekombinant humant kollagen er det vigtige grundlag inden for det medicinske område. Til sidst håber forskerne, at dette materiale kan tjene som et stillads til at dyrke nyt væv in situ. De Rekombinant Insulin Mutation Biofremstilling 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.   

Hvorfor vælge Yaohai Recombinant Human Collagen Production Process?

• Kvalitetssystem og overholdelse af global lovgivning

  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.

• Tilpasning, effektivitet og omkostningseffektivitet

  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

• Professionel ekspertise og bred erfaring

  Yaohai Bio-Pharma, en leder inden for CDMO'er af mikrobielle biologiske stoffer, har hovedkvarter i Jiangsu. Vi har været fokuseret på mikrobielt producerede lægemidler og vacciner, der er velegnede til mennesker, veterinær og styring af rekombinant human kollagenproduktionsproces. Vi har de mest avancerede RD- såvel som produktionsteknologiske platforme, som dækker hele processen fra Microbial strain engineering, cellebanking samt proces- og metodeudvikling til kommerciel og klinisk fremstilling, hvilket sikrer succesfuld levering af de mest banebrydende løsninger. Vi har akkumuleret en enorm mængde erfaring i biobehandling af mikrobielle celler. Vi har leveret over 200 projekter over hele kloden og har hjulpet vores kunder med at navigere i reglerne og forskrifterne fra US FDA, EU EMA, Australia TGA og China NMPA. Vores ekspertviden og store erfaring gør os i stand til hurtigt at tilpasse os markedets behov og tilbyde skræddersyede CDMO-tjenester.

• Robust forsyningskæde og produktionskapacitet

  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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