GMP tuberkulózis (TB) antigéngyártás Magyarország

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  GMP Tuberculosis (TB) Antigen Production

  This test is specially critical as majority of people with TB don't show any symptoms of being sick. They may only feel OK but the germs could still live inside their bodies. Without the antigen test, it becomes difficult for doctors to recognize if they have TB. GMP Tuberculosis (TB) Antigen, though, allows us to see if you would benefit from treatment or not.

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  A Critical Step Towards TB Diagnosis

  Unfortunately, there is currently no way of testing for latent TB that works on all sufferers. And not so much new tests but working on things we can test, more quickly and have them be less expensive to run than what we have now. One of those is finding new ways to minimize the volume of blood required for testing (and therefore make things less stressful on patients). In addition, they would like to create new therapies that can help individuals heal faster and have fewer side effects.

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  Innovations in GMP Tuberculosis (TB) Antigen Manufacturing for Improved Diagnosis and Treatmen

  One such company that is crafting these new advancements are Yaohai The are redeveloping GMP Tuberculosis (TB) Antigen using state-of-the-art technology to make the product and process safer and more efficient. This means that their generated antigen is not only potent but also the safest. They are also developing tests that a faster and require less blood from patients.

Why choose Yaohai GMP Tuberculosis (TB) Antigen Manufacturing?

• Robusztus ellátási lánc és gyártási képességek

  Yaohai Bio-Pharma, a top 10 manufacturer of biological products, specializes in microbial fermentation. We have created a GMP Tuberculosis (TB) Antigen Manufacturing 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.

• Minőségi rendszer és globális szabályozási megfelelőség

  GMP Tuberculosis (TB) Antigen Manufacturing is a Top 10 Microbial CDMO that incorporates quality control and regulatory matters. We have established a robust quality system that complies with the current GMP standards and regulations all over the world. Our regulatory team is well-versed on global regulatory frameworks to speed up biological launches. We guarantee traceable production processes and top-quality products that are compliant with the rules of US FDA, EU EMA, Australia TGA, and China NMPA. Yaohai BioPharma successfully passed an audit on site conducted by an accredited Qualified Person from the European Union (QP) to review our GMP system and production facility. Additionally, we've passed the first certification audits of the ISO9001 Quality Management System, ISO14001 Environmental Management System, and ISO45001 Occupational Health and Safety Management System.

• Szakmai szakértelem és kiterjedt tapasztalat

  Yaohai Bio-Pharma is a leading microbial biologics CDMO. Our main focus has been the production of GMP Tuberculosis (TB) Antigen Manufacturing and therapeutics to treat pets, human and veterinary health. We have state-of-the-art RD platforms and manufacturing technology that cover the entire manufacturing process beginning with the development of microbial strains Cell banking, process and method development, through commercial and clinical manufacture that ensures the successful delivery of innovative solutions. Over time we've gained a vast knowledge of microbial-based bio processing. We have successfully completed more than 200 global projects, and help our clients with navigating the rules and regulations of the US FDA, EU EMA, Australia TGA, and China NMPA. We are able to react promptly to market demands and provide tailored CDMO services due to our experience and expertise.

• Testreszabás, hatékonyság és költséghatékonyság

  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 GMP Tuberculosis (TB) Antigen Manufacturing 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

Kapcsolódó termékkategóriák

• GMP Semaglutide API
• GMP Szemaglutid gyártás
• Vírusszerű részecske (VLP) Vaccine GMP Manufacturing
• GMP Anti-CD8 VHH gyártás
• GMP Anti-EGFR VHH gyártás
• GMP Anti-HER3 VHH gyártás
• GMP Anti-MMRCD206 VHH
• GMP Anti-PD-1PD-L1 VHH
• GMP CMV antigén gyártás
• GMP Fab Fragment Production

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