Sterile Abfüllung und Fertigstellung Deutschland

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  Minimizing Risk with Sterile Fill and Finish Techniques

  Maintaining the quality of our medicines we choose to utilize clean fill and finish methods. These methods are intended to increase the effort necessary for germs to enter into medicines during the final parts of their manufacture. There are special methods and equipment so that everything looks clean. Such as the special robes that we wear to protect our body, or the specially designed machine that keeps everything sterile. We rigorously test our products to ensure they are of high quality as well. 

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  Meeting Regulatory Standards with Sterile Fill and Finish Operations

  All medicines are of course made with the highest level of vigilance to make sure they will be safe for patients by these health agencies. Institutions such as the FDA are very vigilant for cleaning processes and product quality. The latter are designed to protect patients and make sure they get the right medicines. Therefore, through the use of clean fill and finish lines, Yaohai can follow these rules closely to ensure that we give our clients pharmaceuticals that are safe and high-quality. These rules are not a mere compliance but they serve the commitment to our patients and their health.

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  Maximizing Product Safety with Sterile Fill and Finish Protocols

  The initial steps involved in clean fill and finish are specifically designed so that you remain safe and germs are kept out so that the medicine remains effective. Diversified to check quality for Yaohai These checks ensure that medicaments are safe and work the same way. For example, we employ unique filters that trap any germs before entering our medication. We have far more thorough methods of cleaning the bins so that everything is sanitized. We also test thoroughly to ensure contamination, and then we use our clean down system to eliminate the contamination so it cannot seep into any of the pharmaceuticals in production. 

Why choose Yaohai Sterile Fill and Finish?

• Robuste Lieferkette und Fertigungskapazitäten

  Yaohai Bio-Pharma, a top 10 Sterile Fill and Finish of biological products, is a specialist in microbial fermentation. We have set up a modern facility that has robust RD capabilities and advanced infrastructure. Five lines of production for drugs conforming to GMP standards to purify and ferment microbial cells along with two fill and finish lines for vials as well as cartridges and needles pre-filled are readily available. The fermentation scales available for use range from 100L to 2000L. Filling specifications for vias are 1ml to 25ml, whereas pre-filled syringe or cartridge filling requirements are between 1-3ml. The production workshop is cGMP certified and offers the availability of commercial and clinical samples. The large molecules manufactured in our facility are available for delivery worldwide.

• Anpassung, Effizienz und Kosteneffizienz

  Yaohai Bio-Pharma has experience in the manufacture of biologics created from microorganisms We offer bespoke RD solutions as well as manufacturing services while minimizing the risk We've worked with diverse modalities such as recombinant subunit vaccines peptides hormones cytokines growth factors mono-domain antibodies enzymes plasmid DNA the mRNA and other We've specialized in several microorganisms like yeast extracellular and intracellular secretion (yields up to 15g/L) bacteria intracellular soluble and inclusion bodies (yields up to 10g/L) We have also created a BSL-2 fermentation system to create Sterile Fill and Finish vaccines We are experts in optimizing production processes increasing yields and decreasing costs We have a highly efficient technology team that ensures timely and top-quality project delivery This allows us to deliver your products that are unique faster to the market

• 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 Sterile Fill and Finish 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.

• Fachkompetenz und langjährige Erfahrung

  Yaohai Bio-Pharma is a leading microbiological CDMO. Our focus has been on microbially produced Sterile Fill and Finish 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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