Microbial Cell Substrate for Biological Products Indonesia

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  The future of biological product development utilizing microbial cell substrates.

  In its work, Yaohai is always seeking out new and innovative ways of employing microbial cells. Through these tiny cells they think that they can deliver many more products to improve our health, and as a team help protect our planet. They aim to create in the future new drugs that can cure much more diseases. They also want to be creating products that are good for the environment like biodegradable plastic. This is a way of natural breakdown of this plastic without releasing any harmful things into the environment. Using the power of microbial cell engineering, Yaohai Microbial CDMO for Human Biologics is working to create a better world for everyone. 

  
  

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  A sustainable and efficient solution for bioproduction.

  It makes great sense to produce things using microbial cells, with their ability to make complicated molecules in sustainable way. It consumes less energy, and a few resources of the people's ways to use it. Secondly, the particular cells of microorganisms can be developed at an exceptionally huge scope in the territory which is very little; this makes them amazingly productive. This implies that Yaohai will be able to manufacturer a great no. of products without causing harm to environment. This is a win-win, both helping people and the soil. 

  
  

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  An innovative approach to biotechnology.

  Yaohai believes that biotechnology will be used in a creative way. The deeper insight they gain, the more ways they look at using these living microbial cells to improve in their research. For example, create novel products, which will eventually help people more healthier and also support the environment. They are also helping in evolving the biotech industry by establishing new methodologies and techniques that can be deployed in the coming times. 

  
  

Why choose Yaohai Microbial Cell Substrate for Biological Products?

• Keahlian Profesional & Pengalaman Luas

  Yaohai Bio-Pharma is a leading Microbial biologics CDMO. We have been focused on microbial-produced therapeutics and vaccines for human, veterinary, and the management of pet health. We are equipped with Microbial Cell Substrate for Biological Products RD platforms as well as manufacturing technology that encompass the entire process beginning with the development of microbial strains cells, methods and processes, to commercial and clinical manufacturing which ensures successful implementation of cutting-edge solutions. We have acquired a large amount of experience in bio processing of microbial cells. We have delivered over 200 global projects, and help our clients with navigating the laws from the US FDA, EU EMA, Australia TGA, and China NMPA. Our professional expertise and extensive experience allows us to quickly respond to market demands and provide tailored CDMO services.

• Kustomisasi, Efisiensi & Efektivitas Biaya

  Yaohai Bio-Pharma is experienced in biologicals derived from microbial sources. We provide customized RD solutions and manufacturing, while minimising potential risks. We have worked on various modalities, including recombinant subunit vaccines, peptides hormones, cytokines growth factors, single-domain antibodies enzymes, plasmid DNA various mRNAs, and more. We have specialized in multiple microorganisms, including Microbial Cell Substrate for Biological Products intracellular and extracellular secretion (yields up to 15g/L) and intracellular soluble bacteria and inclusion body (yields up to 10g/L). We have also established a BSL-2 fermentation platform to create bacteria-based vaccines. We are experts in improving processes, boosting product yields, and decreasing production costs. We have a highly efficient technology team that ensures timely and top-quality project delivery. This allows us to bring your unique products faster to market.

• Sistem Mutu & Kepatuhan Terhadap Peraturan Global

  Yaohai BioPharma is a Top 10 Microbial CDMO that integrates quality management and regulatory affairs. We have a quality management system that is in compliance with current Microbial Cell Substrate for Biological Products and regulations around the globe. Our regulatory team is knowledgeable in the global regulatory frameworks that help accelerate biological launches. We ensure traceable production procedures quality products, as well as in compliance with the guidelines of the US FDA and EU EMA. Australia TGA and China NMPA are also in compliance. Yaohai BioPharma has successfully passed the on-site audit by the European Union's qualified Person (QP) for our GMP quality system and production site. We also successfully cleared the first certification audits of the ISO9001 Quality Management System and ISO14001 Environmental Management System.

• Rantai Pasokan & Kemampuan Manufaktur yang Kuat

  Yaohai Bio-Pharma, a Microbial Cell Substrate for Biological Products 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.

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