Fabrication de vaccins à ADN

• Solutions basées sur l'ADN"

  Comment les vaccins à ADN sont-ils fabriqués par les scientifiques ? Ils localisent un gène du germe qu’ils souhaitent utiliser ; Premièrement, il ne s’agit que d’une toute petite longueur d’ADN. C’est un processus très méticuleux car ils doivent sélectionner la bonne partie du germe afin que le système immunitaire puisse l’identifier. Pour commencer, ils copient cet ADN et l’insèrent dans un outil appelé plasmide. (Plasmide = quelque chose qui ressemble à un camion postal) : il aide l'ADN à pénétrer dans les cellules.

• Comment les vaccins à ADN ont un impact important sur la santé publique »

  Le plasmide est maintenant inséré dans une cellule. La cellule commence alors à répliquer l’ADN et à en produire de nombreuses copies. Le vaccin est rapidement fabriqué à partir de ces copies entraînées. Le résultat est que les chercheurs sont capables de produire un gros lot de vaccin en une seule fois, et cette capacité de volume élevée signifie qu'ils peuvent aider davantage de personnes.

• Le processus de fabrication des vaccins à ADN

  Enfin, le vaccin est soumis à des tests rigoureux pour garantir sa sécurité et son efficacité. À FAIRE : Les scientifiques effectuent ces tests pour confirmer que le produit est sûr et efficace. Si le résultat est positif à tous les tests, ils peuvent alors en fabriquer d’énormes quantités et le distribuer à tout le monde. Ainsi, les gens peuvent se faire vacciner et être en bonne santé.

Pourquoi choisir la fabrication de vaccins à ADN Yaohai ?

• Expertise professionnelle et vaste expérience

  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.

• Personnalisation, efficacité et rentabilité

  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.

• Système qualité et conformité réglementaire mondiale

  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.

• Chaîne d’approvisionnement et capacités de fabrication robustes

  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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