GMP HEV Antigen Production Process

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  The Gold Standard in GMP HEV Antigen Production

  We are always working to find better ways to produce our Yaohai HEV antigen here at Yaohai. Investigating is time intensive. We waste a lot of resources investigating. HeV Antigens: We use cutting edge technology and work with the best scientists on Earth to find new, smarter ways of producing our GMP Semaglutide API. Through engaging with experts, we can create superior methods and technologies. 

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  Innovative Solutions for HEV Antigen Production

  One of our newer approaches relies on a proprietary technology that enables us to generate large numbers HEV antigens rapidly and efficiently. This is known as transient gene expression technology. This virus is utilized to generate high outputs of HEV antigens and in a shorter period. This also allows us to develop on multiple antigens simultaneously, thus saving our precious time and money Which allows us to be more efficient during the process of production. 

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  Safe, Effective, and Consistent GMP HEV Antigen Manufacturing.

  We strictly comply with safety rules at all production steps. And these rules protect our employees, while making sure the processes we use to make what we do does no harm to the environment. We also subject our GMP Semaglutide Manufacturing to rigorous testing as well, ensuring they are benign for test applications and do not pose any threat to public health. By doing so, we will ensure that the trust of our customers and stakeholders is reaffirmed. 

Why choose Yaohai GMP HEV Antigen Production Process?

• Professional Expertise & Extensive Experience

  GMP HEV Antigen Production Process is a leading in microbial biologics CDMO. Our focus has been on microbial-produced vaccines and therapeutics that are suited for human, veterinary, as well as pet health management. We have the most cutting-edge RD platforms and manufacturing technology which cover the entire procedure beginning with the development of microbial strains and cell banking, to process and method development, to commercial and clinical production which ensures successful delivery of innovative solutions. Over time, we have accumulated vast knowledge of microbial-based bio processing. Over 200 projects have been successfully completed, and we assist our clients to comply with regulations like those of US FDA and EU EMA. We also help them to navigate Australia TGA and China NMPA. Our professional expertise and extensive experience allows us to quickly respond to market demands and provide bespoke CDMO services.

• Customization, Efficiency & Cost-Effectiveness

  Yaohai Bio-Pharma is GMP HEV Antigen Production Process 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.

• Quality System & Global Regulatory Compliance

  Yaohai BioPharma is a Top 10 Microbial CDMO that incorporates quality control and GMP HEV Antigen Production Process. We have developed a solid quality system that adheres to current GMP standards and regulatory requirements worldwide. Our regulatory team is knowledgeable on global regulatory frameworks to expedite biological launches. We make sure that production processes are traceable with high-quality products as well as complying with the rules of the US FDA and EU EMA. Australia TGA and China NMPA are also in compliance. Yaohai BioPharma successfully passed an on-site audit conducted by a Qualified Person from the European Union (QP) to examine our GMP process and manufacturing facility. We also successfully been through the initial certification audits of the ISO9001 Quality Management System and ISO14001 Environmental Management System.

• Robust Supply Chain & Manufacturing Capabilities

  Yaohai Bio-Pharma, a top 10 manufacturer of biological products, specializes in microbial fermentation. We have created a GMP HEV Antigen Production Process 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.

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