Mikrobieller CDMO für Humanbiologika Deutschland

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  Maximizing Efficiency and Quality with Microbial CDMO Services

  Enter Yaohai Corp, Mikrobieller CDMO für Tierbiologie an innovative company leading this exiting paradigm shift. For human critical drugs, Microbial CDMO services are provided to fulfill the manufacturing processes for other companies. Unlike those luxurious hotels where you wished to be served, these services are not only affordable but economical as well. This is to thereby qualify them to assist companies in their biologics manufacturing outputs. Yaohai select the species of microbes, designs whole fermentation processes to make Women Medicine and invalidutes safety methods for safe and effective use. This partnership let's both Yaohai and companies working with them focus on patients because we know there is a partner to get the medicines made.

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  The Key to Faster and More Cost-Effective Biologic Production

  Reduced Cost Medicine Production Fast

  This is highly beneficial to companies, it makes them save time and money creating best quality medicines with the help of Microbial Fermentation Manufacturing Process. Because the number of patients who need biologics is increasing, we need to find more cost-effective means of making these life-saving products. That in turn will enable companies to produce these drugs faster, given that the entire process is being in favor of using microbes. This is important for their care, as this implies a reduced waiting time to receive treatments and care. By driving costs down, pill-in-a-bottle wins literally save more patients like myself.

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  Enhancing the Safety and Efficacy of Human Biologics through Microbial CDMO Technology

  I mean you can provide Pharma companies with a supply chain de-risking that is, in other words, you can be toxic the entire gamut of Teva chemicals so that Microbial CDMO technology safer drugs are possible to develop and they have fewer impurities. The issue here is that the medications using animal cells can also incorporate contaminants which are harmful to human beings. In patients, the threat of this is very real. However, the risk when using microorganisms-bacteria and yeasts is still high. This has the potential to produce much safer and more efficacious treatments in companies running microbial-based medicines. The MoU said “this agreement will help guarantee to patients that they are being delivered high quality medicines through sophisticated technology which puts their health and well-being first.”

Why choose Yaohai Microbial CDMO for Human Biologics?

• 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 Microbial CDMO for Human Biologics 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

• Qualitätssystem und Einhaltung globaler Vorschriften

  Yaohai BioPharma, a Microbial CDMO for Human Biologics Microbial CDMO, integrates regulatory affairs and quality management. We have a quality system that is compliant with current GMP standards, as well as regulations around the globe. Our regulatory team is knowledgeable in global regulatory frameworks to expedite biological launches. We make sure that production processes are traceable, high-quality products, and complying with the rules of the US FDA and EU EMA. Australia TGA and China NMPA is also fulfilled. Yaohai BioPharma has successfully passed the audit on site of the European Union's Qualified Person (QP) to ensure our GMP quality system and production site. We also have 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 created a Microbial CDMO for Human Biologics manufacturing facility with robust RD capabilities and cutting-edge manufacturing facilities. Five drug substance production lines conforming to GMP standards to purify and ferment microbial cells, as well as two fill and finish lines for vials and cartridges, as well as needles that are pre-filled, are available. The available fermentation scales include 100L, 500L, 1000L and 2000L. Specifications for filling vials range from 1ml - 25ml. the pre-filled cartridge or syringe filling specifications range from between 1-3ml. The production workshop is cGMP-compliant and provides a stable supply of commercial products and clinical samples. Our facility produces large molecules that are shipped worldwide.

• Fachkompetenz und langjährige Erfahrung

  Yaohai Bio-Pharma is a leading in microbial biologics CDMO. Our primary focus is the production of microbial vaccinations and therapeutics for managing pets, human and Microbial CDMO for Human Biologics. We are equipped with cutting-edge RD platforms as well as manufacturing technologies that encompass the entire process beginning with the development of microbial strains and cell banking, to method and process development, to clinical and commercial manufacture that ensures the successful supply of new solutions. Through the years, we have accumulated vast knowledge of microbial-based bio processing. Over 200 projects have been successfully completed and we assist our clients to get through regulations, such as those of the US FDA and EU EMA. We also assist them in navigating Australia TGA and China NMPA. We are able respond promptly to market demands and offer tailored CDMO services thanks to our experience and expertise.

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