VLP-Fermentations- und Reinigungsprozess Deutschland

• Wie die VLP-Fermentation die biopharmazeutische Produktion revolutioniert

  VLPs wurden zur Unterstützung bei der Behandlung einer Vielzahl von Krankheiten vorgeschlagen, von Krebs bis Grippe. Indem sie Viren imitieren, helfen sie unserem Körper, sie zu erkennen und uns vor Krankheiten zu schützen. Das ist so spannend, weil es uns die Mittel gibt, uns bei all diesen Krankheiten zu verbessern, die so große Teile der Menschheit plagen.

• Eine vereinfachte Anleitung zum Fermentations- und Reinigungsprozess

  Aber die Herstellung von VLPs ist keine leichte Aufgabe. Dazu müssen wir sie so herstellen, dass sie die richtige Form annehmen und erst dann als Medikament verwendet werden können. Und genau hier kommt die Kunst der Fermentation ins Spiel. Heutzutage produzieren biopharmazeutische Unternehmen VLPs in einem noch nie dagewesenen Maßstab durch Fermentation und zielen darauf ab, Behandlungen zu erschwinglichen Preisen anzubieten.

• Die Reise der VLP-Produktion".

  Die erste Entscheidung, die die Wissenschaftler treffen müssen, betrifft die Mikroorganismen, die sie für die Fermentation verwenden möchten. Sie müssen auch herausfinden, welche Nährstoffe diesen Mikroorganismen beim Gedeihen helfen und das ideale VLP produzieren. Genau wie bei der Auswahl der richtigen Zutaten für ein Rezept.

Warum sollten Sie sich für das VLP-Fermentations- und Reinigungsverfahren von Yaohai entscheiden?

• Fachkompetenz und langjährige Erfahrung

  Yaohai Bio-Pharma, a leader in CDMOs of microbial biologics, is headquartered in Jiangsu. We have been focused on microbially produced therapeutics and vaccines that are suited for human, veterinary and the management of VLP Fermentation and Purification Process. We have the most the most advanced RD as well as manufacturing technology platforms, which cover the entire process from Microbial strain engineering, cell banking as well as process and method development to commercial and clinical manufacturing, assuring the successful supply of the most cutting-edge solutions. We have accumulated a huge amount of experience in the bio processing of microbial cells. We have delivered over 200 projects across the globe and have assisted our clients with navigating the rules and regulations of the US FDA, EU EMA, Australia TGA, and China NMPA. Our expert knowledge and vast experience enable us to swiftly adapt to market needs and offer tailored CDMO services.

• Qualitätssystem und Einhaltung globaler Vorschriften

  Yaohai BioPharma is a Top 10 Microbial CDMO that incorporates quality control and regulatory matters. We have a quality system which is in line with current GMP standards and international regulations. Our regulatory team is knowledgeable in global regulatory frameworks to accelerate biological launches. We ensure traceable manufacturing processes and top-quality products that are compliant with the requirements of the US FDA, EU EMA, Australia TGA, and VLP Fermentation and Purification Process. Yaohai BioPharma has successfully passed the audit on site of the European Union's qualified Person (QP) for our GMP quality system and production site. In addition, we've cleared 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 VLP Fermentation and Purification Process, 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.

• Anpassung, Effizienz und Kosteneffizienz

  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 VLP Fermentation and Purification 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

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