VLP-Impfstoffproduktion in E. coli Deutschland

• E.coli VLP-Produktion

  In diesem Verfahren werden synthetische VLPs hergestellt. Mithilfe von E.coli ist dies für Wissenschaftler eine viel schnellere und kostengünstigere Methode. Dies ist sicherlich eine schnellere Methode zur Herstellung von Impfstoffen als alte Methoden, die tierische Zellen erforderten und äußerst komplex waren. Mit den alten Methoden werden Impfstoffe erst nach Monaten oder sogar Jahren hergestellt, was nicht gut ist, da Menschen dabei sterben.

• VLP-Impfstoffproduktion dank E.coli-Technologie möglich

  Die Einführung der E.coli-Technologie in der Impfstoffproduktion hat den Gesundheitssektor revolutioniert, insbesondere während Pandemien. Dadurch können Impfstoffe auch billiger, schneller und einfacher hergestellt werden. Dieser neue Ansatz ermöglicht auch die Entwicklung von Impfstoffen für Krankheiten, gegen die es bisher schwierig war zu impfen, wie zum Beispiel einige besonders komplexe Viren.

• Ein Wendepunkt in der Impfstoffproduktion durch E.coli

  Produktion virusähnlicher Partikel mit E.coli: Die Namedoji-Technologie basiert auf der effizienten Expression selbstassemblierender VLPs in Bakterien zur Entwicklung als Impfstoff gegen Grippe, Ebola und humane Papillomaviren. Diese Impfstoffe schützen Menschen vor Krankheiten. Die Technologie hat auch eine große Rolle bei der Herstellung der Covid-19-Impfstoffe gespielt, die entscheidend zur Beendigung dieser Pandemie und zur Rettung von Menschenleben beigetragen haben.

Warum sollten Sie sich für die VLP-Impfstoffproduktion von Yaohai in E. coli entscheiden?

• Fachkompetenz und langjährige Erfahrung

  Yaohai Bio-Pharma, a leader in CDMOs for microbial biologics, is located in Jiangsu. We are focusing on microbially produced therapeutics and vaccines that are VLP Vaccine Production in E. coli for human, veterinary as well as pet health management. We have the most cutting-edge RD platforms as well as manufacturing technology that cover the entire manufacturing process, from microbial strain development, cell banking, process and method development to clinical and commercial manufacture which ensures successful production of novel solutions. We have gained an extensive amount of experience in bio processing of microbial cells. More than 200 projects have been successfully completed, and we support our clients in get through regulations, such as those of US FDA as well as EU EMA. We also aid them with Australia TGA and China NMPA. Our experience and professional knowledge as well as our extensive knowledge allow us to quickly respond to market demands and provide customized CDMO services.

• Qualitätssystem und Einhaltung globaler Vorschriften

  Yaohai BioPharma, a top 10 Microbial CDMO that integrates quality management and regulatory affairs. Our quality system that is compliant with current GMP standards as well as international regulations. Our team of regulatory experts is proficient in global regulatory frameworks to accelerate biological launches. We ensure traceable production procedures quality products, as well as conformity with the requirements of the VLP Vaccine Production in E. coli and EU EMA. Australia TGA and China NMPA are also met. Yaohai BioPharma successfully passed an in-person audit conducted by a Qualified Person of the European Union (QP) to examine our GMP system and production facility. We also completed 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 producer of biological products, is a specialist in microbial fermentation. We have established an advanced facility that is equipped with modern facilities and strong RD manufacturing capabilities. We have five drug substance manufacturing lines that are in compliance with GMP requirements for microbial fermentation and purification, as well as two fill-finish lines that are automated for cartridges, vials, as well as pre-filled syringes. The available fermentation scales vary from 100L to 500L, 1000L and 2000L. VLP Vaccine Production in E. coli for vias are 1ml to 25ml, whereas the pre-filled syringes and cartridge filling specifications cover 1-3ml. Our production workshop is cGMP compliant and guarantees steady supply of clinical samples as well as commercial items. Our plant produces large molecules which are shipped to the globe.

• Anpassung, Effizienz und Kosteneffizienz

  Yaohai Bio-Pharma has experience in the production of biologics created from VLP Vaccine Production in E. coli. We offer customized RD and manufacturing solutions while making sure that there are no risks. We have been involved in diverse modalities such as subunit vaccines recombinant, peptides hormones, cytokines, growth factors, single-domain antibodies enzymes, plasmid DNA MRNA, and many more. We are a specialist in many microorganisms, including yeast extracellular and intracellular secretion (yields up to 15g/L) as well as bacteria intracellular soluble and inclusion body (yields as high as 10g/L). We have also created a BSL-2 fermentation platform to create bacterial vaccines. We focus on improving processes, increasing product yields, and reducing production costs. Utilizing a strong technology team, we can ensure prompt and reliable project delivery that will bring your product to market faster.

Verwandte Produktkategorien

Finden Sie nicht, was Sie suchen?
Kontaktieren Sie unsere Berater für weitere verfügbare Produkte.