Truncated Tissue Plasminogen Activator (tPA) Manufacturing

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  Maximizing Yield in truncated tPA Manufacturing

  Yaohai has also discovered ways to increase the amount of truncated tPA they can generate during manufacturing. The implication of this is that they can produce a high volume of truncated tPA free of other proteins over a relatively short time period. They do this by optimizing processes like fermentation and purification. Fermentation grows the right materials for tPA, while purification makes sure the final product is clean and safe for patients. This is why we aim to streamline those processes so that more people can receive this crucial treatment.

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  Reducing Costs with Truncated tPA Production

  Yaohai can then make the medicine at a lower cost using truncated tPA. This truncated version of tPA is as effective as regular tPA, but at a significantly reduced cost. This is good news for patients and health providers as they can save on the treatment. When costs come down, more people can get the help they need. This this access is key because everyone should be able to access life saving treatment without fear of high cost.

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  Streamlining Truncated tPA Manufacturing for Faster Access to Life-Saving Treatmen

  Now, with much better ways to make truncated tPA, Yaohai can do it dead quick. This is particularly necessary for patients who require this critical medicine urgently. If something bad happens, like a natural disaster or a pandemic, the ability to quickly produce more tPA could save lives. Yaohai promises to make this life-saving treatment available for patients when they need it most. Their quick turnaround in response to increased demand is a big part of what their mission.

Why choose Yaohai Truncated Tissue Plasminogen Activator (tPA) Manufacturing?

• Kvalitetssystem og overholdelse af global lovgivning

  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. Truncated Tissue Plasminogen Activator (tPA) 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.

• Robust forsyningskæde og produktionskapacitet

  Yaohai Bio-Pharma, a top 10 Truncated Tissue Plasminogen Activator (tPA) Manufacturing of biological products, is a specialist in microbial fermentation. We have set up a modern facility that has robust RD capabilities and advanced infrastructure. Five lines of production for drugs conforming to GMP standards to purify and ferment microbial cells along with two fill and finish lines for vials as well as cartridges and needles pre-filled are readily available. The fermentation scales available for use range from 100L to 2000L. Filling specifications for vias are 1ml to 25ml, whereas pre-filled syringe or cartridge filling requirements are between 1-3ml. The production workshop is cGMP certified and offers the availability of commercial and clinical samples. The large molecules manufactured in our facility are available for delivery worldwide.

• Tilpasning, effektivitet og omkostningseffektivitet

  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 Truncated Tissue Plasminogen Activator (tPA) Manufacturing 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.

• Professionel ekspertise og bred erfaring

  Yaohai Bio-Pharma is a leading in microbial biologics CDMO. Our primary focus is the production of microbial vaccinations and therapeutics for managing pets, human and Truncated Tissue Plasminogen Activator (tPA) Manufacturing. We are equipped with cutting-edge RD platforms as well as manufacturing technologies that encompass the entire process beginning with the development of microbial strains and cell banking, to method and process development, to clinical and commercial manufacture that ensures the successful supply of new solutions. Through the years, we have accumulated vast knowledge of microbial-based bio processing. Over 200 projects have been successfully completed and we assist our clients to get through regulations, such as those of the US FDA and EU EMA. We also assist them in navigating Australia TGA and China NMPA. We are able respond promptly to market demands and offer tailored CDMO services thanks to our experience and expertise.

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