SaRNA-Qualitätskontrolle Deutschland

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  Häufige Probleme und Lösungen

  A second key tactic is to put tons of tests on the saRNA. This way, scientists are able to detect any issues that may crop up by carrying out a number of tests. In this way, the saRNA remains essentially constant so it will always act in the same predictable manner each time they make more of it. The key to making a saRNA that works in medicine and experimentation alike is consistency. 

  
  

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  SaRNA Quality Control Strategies

  The technology of nucleotide sequencing has been revolutionized in the past few years. Next-Generation Sequencing (NGS) is one such example. They are also sequenced on an NGS platform in n number which reads millions of nucleotides at a time. This does not only help the scientist to collect a lot of data very fast but also saves them from any data capture error. 

  
  

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  Advancements in Nucleotide Analysis and More

  You can use the companies facilities for NGS so that scientists on the other end can control the saRNA to make certain it is specific and not doing any off targeting of DNA. This is critical as we want to ensure that saRNA targets only at our gene of interest. In addition to healthy control samples, the saRNA stability and mutation or change of nucleotide sequence can also be detected through NGS. This helps to ensure that the saRNA does its job without running. 

  
  

Why choose Yaohai SaRNA Quality Control?

• Anpassung, Effizienz und Kosteneffizienz

  Yaohai Bio-Pharma is saRNA Quality Control in microbial-derived biologics. We offer custom RD as well as manufacturing solutions, while minimising the risk. We've been involved in numerous modalities like recombinant subunit vaccines, peptides hormones, cytokines growth factors, single-domain antibodies, enzymes, plasmid DNA, the mRNA, and other. We are experts in several Microbial hosts, such as yeast extracellular and intracellular (yield up to 15 grams per liter) bacteria periplasmic secretion as well as soluble intracellular inclusion bodies (yield up to 10 grams/L). Additionally, we have developed the BSL-2 microbial fermentation platform for the development of bacterial vaccines. We have a track record of improving production processes, thereby increasing yields, and reducing costs. With a highly efficient technology team, we guarantee prompt and reliable project delivery and bring your products to market quicker.

• Fachkompetenz und langjährige Erfahrung

  saRNA Quality Control is a leading in microbial biologics CDMO. Our focus has been on microbial-produced vaccines and therapeutics that are suited for human, veterinary, as well as pet health management. We have the most cutting-edge RD platforms and manufacturing technology which cover the entire procedure beginning with the development of microbial strains and cell banking, to process and method development, to commercial and clinical production which ensures successful delivery of innovative solutions. Over time, we have accumulated vast knowledge of microbial-based bio processing. Over 200 projects have been successfully completed, and we assist our clients to comply with regulations like those of US FDA and EU EMA. We also help them to navigate Australia TGA and China NMPA. Our professional expertise and extensive experience allows us to quickly respond to market demands and provide bespoke CDMO services.

• Qualitätssystem und Einhaltung globaler Vorschriften

  saRNA Quality Control is a Top 10 Microbial CDMO that incorporates quality control and regulatory matters. We have established a robust quality system that complies with the current GMP standards and regulations all over the world. Our regulatory team is well-versed on global regulatory frameworks to speed up biological launches. We guarantee traceable production processes and top-quality products that are compliant with the rules of US FDA, EU EMA, Australia TGA, and China NMPA. Yaohai BioPharma successfully passed an audit on site conducted by an accredited Qualified Person from the European Union (QP) to review our GMP system and production facility. Additionally, we've passed the first certification audits of the ISO9001 Quality Management System, ISO14001 Environmental Management System, and ISO45001 Occupational Health and Safety Management System.

• Robuste Lieferkette und Fertigungskapazitäten

  Yaohai Bio-Pharma, a top 10 producer of saRNA Quality Control, specializes in microbial fermentation. We have set up a modern facility with advanced facilities as well as robust RD manufacturing capabilities. Five production lines for drug substances complying with GMP standards for microbial purification and ferment along with two automated fill and finish lines for vials as well as cartridges as well as pre-filled needles are readily available. The available fermentation scales range between 100L and 2000L. Vial filling specifications cover 1ml - 25ml. the pre-filled cartridge or syringe filling specifications are between 1-3ml. The production workshop is cGMP certified and offers the availability of commercial and clinical samples. Our plant produces big molecules that are exported to all over the world.

Verwandte Produktkategorien

• Entwicklung eines SaRNA-Reinigungsprozesses
• SaRNA-Reinheitstest
• SaRNA-Qualitätskontrolle

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