CDMO biofarmaceutic România

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  Biopharmaceutical CDMO as Your One-Stop Shop

  We are a team of trained professionals who hold Ph. PhD scientists, engineers & technologists. All of them have numerous years in biopharmaceutical drug development and manufacturing. Based on their extensive know-how and expertise, we are able to meet the highest regulatory standards for the manufacture of our high-quality drugs, which also guarantees safety for patients. 

  
  

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  Biopharmaceutical CDMO Expertise

  Biopharma is such a dynamic industry. With new technologies, regulations and consumer preferences around what they want from their medicines changing; drug manufacturers need to be able to pivot rapidly in order to remain competitive. This is crucial in making sure that patients receive the most up-to-date and optimal therapies that are first tested on animals before being brought into the clinic for human studies. 

  
  

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  Keeping Pace with Evolving Industry Demands

  To sum up, biopharmaceutical CDMO like Yaohai are essential in the intermediate links of drugs development and production. The range of equipment expertise and services available help medicine and biotechnological companies create drugs at affordable cost. And that in turn means we get life-saving medicines to market faster and more easily, so many more people around the world can use the treatments they need. 

  
  

Why choose Yaohai Biopharmaceutical CDMO?

• Personalizare, eficiență și rentabilitate

  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 Biopharmaceutical CDMO 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.

• Lanț de aprovizionare robust și capabilități de producție

  Yaohai Bio-Pharma is a Top 10 biological company that specializes in Biopharmaceutical CDMO. We have built a modern manufacturing facility with robust RD capabilities and modern manufacturing facilities. Five drug substance production lines complying with GMP standards for microbial fermentation and purification along with two fill and final lines for vials and cartridges as well as pre-filled needles are readily available. The available fermentation scales vary between 100L and 2000L. The filling volume ranges from 1ml up to 25ml. Syringes or cartridges that are pre-filled are filled with 3 to 3.5ml. Our production workshop that is cGMP-compliant ensures constant supply of clinical sample and commercial products. Our facility produces large molecules that are exported to all over the world.

• Sistemul de calitate și conformitatea cu reglementările globale

  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 Biopharmaceutical CDMO 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.

• Experiență profesională și experiență vastă

  Yaohai Bio-Pharma is a leading in microbial biologics CDMO. Our main focus has been the production of microbial vaccinations and therapeutics to manage the health of pets, humans and animals. health. We have modern RD and manufacturing technology platforms that cover the entire process, from microbial strain engineering, cell banking, process and method design to commercial and clinical manufacturing, which ensures the success supply of the most cutting-edge solutions. Through the years we have gained vast expertise in using microbial sources. Over 200 projects were successfully completed. In addition, we support our clients in get through regulations, such as those of the US FDA as well as EU EMA. We also help them to navigate Australia TGA and China NMPA. Our expert knowledge and vast experience allow us to quickly respond to market demands and provide Biopharmaceutical CDMO CDMO services.

Categorii de produse înrudite

• Biologice microbiene CDMO
• CDMO biofarmaceutic
• Creșterea procesului microbian biofarmaceutic

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