Ontwikkeling en productie van microbiële biologische producten Nederland

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  Microbial Biologics Development from Lab to Marke

  Did You Know: It takes a long time to make a microbial biologic and for it to be ready for people to use—years sometimes. For hours on end, scientists study and compare microbes to discover which ones are best at producing GMP Anti-HER3 VHH-productie medicine. After they locate the right kind, they scale up production of it to make the medicine. Their testing and refining process starts with the design stage followed by many subsequent steps to ensure everything is needs to be done right while remaining safe.

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  Process Optimization for Cost-effective and Sustainable Microbial Biologics Manufacturing

  We are excited to create safe, and environmentally friendly microbial biologics in all our processes at Yaohai GMP Anti-MMRCD206 VHH. Of course, we aspire to ensure that our products will not only be lucrative but actually help the earth. That matters because manufacturing microbial biologics requires a large input of resources — water and energy in particular. This is good, because so much focus has gone into cleaner processes which means we can keep on producing the medicine we need for true sustainability.

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  Regulatory Considerations for Microbial Biologics Development and Production

  A Microbial biologic must be thoroughly tested and approved by crucial regulatory agencies before it can be marketed to the public, such as FDA (Food and Drug Administration). This is so important because it verifies the safety of the medicine for human use and also that it will work. The development and production of GMP Anti-PD-1PD-L1 VHH microbial biologics involve a major role of regulatory checks, the nature of which must assure high quality standards in final product.

Why choose Yaohai Microbial Biologics Development and Manufacturing?

• Professionele expertise en uitgebreide ervaring

  Yaohai Bio-Pharma is a leading microbiological CDMO. Our focus has been on microbially produced Microbial Biologics Development and 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.

• Robuuste toeleveringsketen en productiecapaciteiten

  Yaohai Bio-Pharma, a Microbial Biologics Development and Manufacturing manufacturer of biological products, is a specialist in microbial fermentations. We have built a modern factory equipped with modern facilities and strong RD and manufacturing capabilities. Five drug substance production lines that are compliant with GMP standards for microbial purification and ferment, as well as two fill and finish lines for vials as well as cartridges, as well as needles that are pre-filled, are readily available. The available fermentation scales vary from 100L to 500L, 1000L, to 2000L. Filling volumes vary from 1ml to 25ml. Syringes or cartridges pre-filled are filled with the equivalent of 1-3ml. Our cGMP-compliant production facility ensures the availability of stable clinical samples and commercial products. The big molecules that are produced at our plant are readily available for international delivery.

• Kwaliteitssysteem en wereldwijde naleving van regelgeving

  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. Microbial Biologics Development and 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.

• Maatwerk, efficiëntie en kosteneffectiviteit

  Yaohai Bio-Pharma is Microbial Biologics Development and Manufacturing in microbial-derived biologics. We offer custom RD as well as manufacturing solutions, while minimising the risk. We've been involved in numerous modalities like recombinant subunit vaccines, peptides hormones, cytokines growth factors, single-domain antibodies, enzymes, plasmid DNA, the mRNA, and other. We are experts in several Microbial hosts, such as yeast extracellular and intracellular (yield up to 15 grams per liter) bacteria periplasmic secretion as well as soluble intracellular inclusion bodies (yield up to 10 grams/L). Additionally, we have developed the BSL-2 microbial fermentation platform for the development of bacterial vaccines. We have a track record of improving production processes, thereby increasing yields, and reducing costs. With a highly efficient technology team, we guarantee prompt and reliable project delivery and bring your products to market quicker.

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