GLP-1 Analoge Fertigung Deutschland

• Effiziente Herstellung eines GLP-1-Analogons für verbesserte Patientenergebnisse

  3D-Druck ist eine sehr interessante Technologie, die auch bei der Entwicklung von GLP-1-Medikamenten eingesetzt wurde. Diese neue Technologie hat es Herstellern ermöglicht, einzigartige Komponenten für die Maschinen herzustellen, die sie in der Produktion verwenden. Durch die Verwendung maßgeschneiderter Teile können Hersteller sicherstellen, dass ihre Maschinen ordnungsgemäß funktionieren und hochwertige Medikamente produzieren, die auf die Bedürfnisse der Patienten zugeschnitten sind.

• Maßgeschneiderte Herstellung von GLP-1-Analoga für maßgeschneiderte Behandlungspläne

  Verbesserung des Supply Chain Managements: Ein weiterer entscheidender Faktor auf dem Weg zu mehr Effizienz. Dazu gehört die Pflege enger Beziehungen zu den Lieferanten, um sicherzustellen, dass alle benötigten Zutaten und Materialien rechtzeitig an ihren Bestimmungsorten ankommen. Dies wiederum bedeutet, dass es weniger Produktionsunterbrechungen gibt und Ihr Medikament sofort verfügbar ist, wenn Sie es am dringendsten benötigen.

• Nachhaltige GLP-1-Analogherstellungsverfahren für eine grünere Zukunft

  Eine Möglichkeit, nachhaltig zu sein, besteht darin, den Energieverbrauch im Herstellungsprozess zu senken. Sie müssen Wege finden, den Energieverbrauch von Maschinen und Prozessen zur Herstellung von Medikamenten zu senken. Hersteller können beispielsweise ihren Energieverbrauch senken, indem sie Solarmodule oder effizientere Maschinen installieren, um dieses Ziel zu erreichen.

Warum sollten Sie sich für Yaohai GLP-1 Analog Manufacturing entscheiden?

• Robuste Lieferkette und Fertigungskapazitäten

  Yaohai Bio-Pharma, a top 10 producer of GLP-1 Analog Manufacturing, 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 has experience in manufacturing biologics that are created from microorganisms. We offer bespoke RD solutions as well as manufacturing services while minimising potential risks. We have worked with diverse techniques, such as recombinant cellular subunits, vaccines (including peptides), growth factors, hormones, and the GLP-1 Analog Manufacturing. We are a specialist in many microorganisms like yeast extracellular and intracellular secretion (yields up to 15g/L) and bacteria intracellular soluble, and inclusion body (yields up to 10g/L). We have also developed a BSL-2 fermentation platform to create bacterial vaccines. We have a track record of improving production processes, thereby increasing yields and reducing costs. We have a highly-efficient technology team to ensure timely and high-quality delivery of projects. This helps us bring your products that are unique faster to the market.

• Qualitätssystem und Einhaltung globaler Vorschriften

  Yaohai BioPharma is a Top 10 Microbial CDMO that incorporates quality management and regulatory issues. We have developed a solid quality management system that conforms to the current GMP standards and regulations globally. Our regulatory team has an in-depth understanding of the world-wide regulatory frameworks. This allows us to accelerate biological launches. We ensure traceable production processes as well as high-quality products and in compliance with the guidelines of the US FDA and EU EMA. GLP-1 Analog Manufacturing and China NMPA are also satisfied. Yaohai BioPharma successfully passed an on-site audit conducted by an accredited Qualified Person of the European Union (QP) to review our GMP system and production facility. We have also been through the first certification audits of the ISO9001 Quality Management System and ISO14001 Environmental Management System.

• Fachkompetenz und langjährige Erfahrung

  Yaohai Bio-Pharma is a leading microbiological CDMO. Our focus has been on microbially produced GLP-1 Analog Manufacturing and vaccines for human, veterinary and the management of pet health. We have state-of-the-art RD platforms and manufacturing methods which cover the entire procedure starting with microbial strain creation and cell banking, to process and method development to commercial and clinical production and implementation of cutting-edge solutions. Over the years we have gained vast expertise in bio processing using microbial sources. We have successfully delivered over 200 projects across the globe and have assisted our clients with navigating the regulations from the US FDA, EU EMA, Australia TGA, and China NMPA. We are able to react rapidly to market requirements and offer a customized CDMO services due to our expertise and knowledge.

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