Herstellung von DNA-Impfstoffen Deutschland

• DNA-basierte Lösungen"

  Wie stellen Wissenschaftler DNA-Impfstoffe her? Sie lokalisieren ein Gen aus dem Keim, das sie verwenden möchten. Zunächst handelt es sich dabei nur um ein winziges Stück DNA. Dies ist ein sehr sorgfältiger Prozess, da sie den richtigen Teil des Keims auswählen müssen, damit das Immunsystem ihn erkennt. Zunächst kopieren sie diese DNA und fügen sie in ein Werkzeug namens Plasmid ein. (Plasmid = so etwas wie ein Postwagen): Es hilft der DNA, in die Zellen zu gelangen.

• Wie DNA-Impfstoffe einen großen Einfluss auf die öffentliche Gesundheit haben"

  Das Plasmid wird nun in eine Zelle eingefügt. Die Zelle beginnt nun, die DNA zu replizieren und produziert zahlreiche Kopien davon. Aus diesen trainierten Kopien wird rasch ein Impfstoff hergestellt. Dadurch können die Forscher eine große Menge des Impfstoffs auf einmal herstellen und dank dieser hohen Kapazität können sie mehr Menschen helfen.

• Der Prozess der Herstellung von DNA-Impfstoffen

  Schließlich wird der Impfstoff strengen Tests unterzogen, um seine Sicherheit und Wirksamkeit sicherzustellen. DO: Wissenschaftler führen diese Tests durch, um zu bestätigen, dass das Produkt sicher und wirksam ist. Wenn es bei allen Tests gut abschneidet, können sie große Mengen davon herstellen und an alle verteilen. So können sich die Menschen impfen lassen und gesund bleiben.

Warum sollten Sie sich für die DNA-Impfstoffherstellung von Yaohai entscheiden?

• Fachkompetenz und langjährige Erfahrung

  Yaohai Bio-Pharma, a leader in DNA Vaccine Manufacturing of microbial biologics, is located in Jiangsu. We are focusing on microbially produced therapeutics and vaccines that are suited for human, veterinary, and pet health management. We have modern RD as well as manufacturing technology platforms that cover the entire process, from engineering microbial strains, cell banking, process and method development, through to commercial and clinical manufacturing, making sure that we can ensure the successful supply of the most cutting-edge solutions. We have acquired a large amount of experience in the microbial bio processing field. More than 200 projects have been completed successfully and we support our clients in overcome regulations such as those of the US FDA and EU EMA. We also aid them with Australia TGA and China NMPA. We are able to respond rapidly to market requirements and offer customized CDMO services thanks to our experience and expertise.

• Anpassung, Effizienz und Kosteneffizienz

  Yaohai Bio-Pharma has experience in the manufacture of biologics derived from microorganisms. We offer tailored RD solutions and manufacturing while minimizing the risk. We have worked with diverse methods, such as DNA Vaccine Manufacturing of vaccines (including peptides), growth factors, hormones, and Cytokines. We specialized in multiple microbial hosts, including yeast extracellular and intracellular (yield up to 15 g/L) bacteria periplasmic secretion, soluble intracellular, and inclusion bodies (yield up to 10 grams/L). We also have a BSL-2 fermentation platform to create bacterial vaccines. We specialize in improving processes, increasing product yields, as well as reducing production costs. We have an efficient technology team that guarantees timely and quality project delivery. This allows us to deliver your exclusive products quicker to market.

• Qualitätssystem und Einhaltung globaler Vorschriften

  Yaohai BioPharma, a top 10 DNA Vaccine Manufacturing, combines regulatory affairs and quality control. We have a quality system that is compliant with current GMP standards and regulations around the globe. Our regulatory team has deep understanding of world-wide regulatory frameworks. This lets us accelerate biological launches. We ensure traceable production procedures with high-quality products as well as compliance with the regulations of the US FDA and EU EMA. Australia TGA and China NMPA is also fulfilled. Yaohai BioPharma successfully passed an in-person audit conducted by an accredited Qualified Person of the European Union (QP) to examine our GMP system and production facility. We have also passed the initial certification audits of the ISO9001 Quality Management System and ISO14001 Environmental Management System.

• Robuste Lieferkette und Fertigungskapazitäten

  Yaohai Bio-Pharma, a top 10 manufacturer of biological products, specializes in microbial fermentation. We have built a modern facility with robust RD capabilities and advanced equipment. We have five drug substance manufacturing lines that conform to GMP requirements for microbial fermentation and purification. We also have two automated fill-finish lines for cartridges, vials and pre-filled syringes. The fermentation scales available for use range from DNA Vaccine Manufacturing to 2000L. The specifications for the filling of a vial range from 1ml up to 25ml. pre-filled syringe or cartridge filling specifications range from approximately 1-3ml. Our cGMP-compliant production facility ensures constant supply of clinical sample as well as commercial items. Our plant produces big molecules which are shipped to the globe.

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